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Tiotropium In Exercise

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Exercise

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

tiotropium 18 mcg

Placebo

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

All patients must sign an informed consent
Diagnosis of COPD with specific spirometric criteria (determined at study visits)
Age >= 40 years
Medical Research Council Dyspnoea score >= 2
Current or ex-smoker with a >= 10 pack-year smoking history
Ability to exercise on treadmill

Exclusion criteria

Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment
Clinical history of asthma
Use of supplemental oxygen therapy
Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)
Recent history (<= 12 months) of myocardial infarction
Unstable or life-threatening cardiac arrhythmia
Malignancy treated with radiation therapy or chemotherapy in the last 5 years
Pregnant or nursing women
Known hypersensitivity to anticholinergic drugs or any component of the study medications
Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1
Estimated life expectancy < 2 years
Symptomatic prostatic hyperplasia or bladder neck obstruction
Known narrow-angle glaucoma
Any condition that is contraindicated for exercise
Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing
Body mass index < 18 kg/m2 or >35 kg/m2 list truncated for space

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tiotropium 18mcg

Placebo

Arm Description

Oral inhalation once daily of 18mcg tiotropium via handihaler

Oral inhalation once daily of placebo matching tiotropium via handihaler

Outcomes

Primary Outcome Measures

90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Secondary Outcome Measures

90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase

Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)

Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase

Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)

Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase

Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)

Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase

COPD exacerbation is a complex of symptoms related to COPD with a duration of three days or more requiring a change of treatment.

90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status

Clinical Relevant Abnormalities for Vital Signs and Physical examination, including vital status. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.

Full Information

NCT ID

NCT00525512

First Posted

September 3, 2007

Last Updated

November 27, 2013

Sponsor

Boehringer Ingelheim

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00525512

Brief Title

Tiotropium In Exercise

Official Title

A Randomized, Double-blind, Placebo-controlled Two-year Trial to Examine the Changes in Exercise Endurance and COPD Treated With Tiotropium Once Daily (EXACTT)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Boehringer Ingelheim

Collaborators

Pfizer

4. Oversight

5. Study Description

Brief Summary

The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with COPD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive, Exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

519 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tiotropium 18mcg

Arm Type

Experimental

Arm Description

Oral inhalation once daily of 18mcg tiotropium via handihaler

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Oral inhalation once daily of placebo matching tiotropium via handihaler

Intervention Type

Drug

Intervention Name(s)

tiotropium 18 mcg

Intervention Description

Oral inhalation once daily of 18mcg tiotropium via handihaler

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral inhalation of once-daily placebo matching tiotropium via handihaler

Primary Outcome Measure Information:

Title

90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase

Description

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Time Frame

baseline, 96 weeks

Secondary Outcome Measure Information:

Title

90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase

Description

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Time Frame

baseline, 8 weeks

Title

90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase

Description

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Time Frame

baseline, 16 weeks

Title

90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase

Description

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Time Frame

baseline, 32 weeks

Title

90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase

Description

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Time Frame

baseline, 48 weeks

Title

90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase

Description

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Time Frame

baseline, 64 weeks

Title

90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase

Description

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Time Frame

baseline, 80 weeks

Title

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase

Description

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time Frame

baseline, 8 weeks

Title

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase

Description

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time Frame

baseline, 16 weeks

Title

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase

Description

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time Frame

baseline, 32 weeks

Title

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase

Description

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time Frame

baseline, 48 weeks

Title

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase

Description

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time Frame

baseline, 64 weeks

Title

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase

Description

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time Frame

baseline, 80 weeks

Title

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase

Description

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time Frame

baseline, 96 weeks

Title

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase

Description

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time Frame

baseline, 8 weeks

Title

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase

Description

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time Frame

baseline, 16 weeks

Title

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase

Description

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time Frame

baseline, 32 weeks

Title

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase

Description

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time Frame

baseline, 48 weeks

Title

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase

Description

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time Frame

baseline, 64 weeks

Title

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase

Description

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time Frame

baseline, 80 weeks

Title

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase

Description

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time Frame

baseline, 96 weeks

Title

Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase

Description

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time Frame

baseline, 8 weeks

Title

Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase

Description

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time Frame

baseline, 16 weeks

Title

Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase

Description

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time Frame

baseline, 32 weeks

Title

Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase

Description

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time Frame

baseline, 48 weeks

Title

Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase

Description

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time Frame

baseline, 64 weeks

Title

Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase

Description

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time Frame

baseline, 80 weeks

Title

Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase

Description

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time Frame

baseline, 96 weeks

Title

Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase

Description

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time Frame

baseline, 8 weeks

Title

Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase

Description

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time Frame

baseline, 16 weeks

Title

Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase

Description

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time Frame

baseline, 32 weeks

Title

Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase

Description

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time Frame

baseline, 48 weeks

Title

Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase

Description

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time Frame

baseline, 64 weeks

Title

Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase

Description

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time Frame

baseline, 80 weeks

Title

Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase

Description

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time Frame

baseline, 96 weeks

Title

Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase

Description

Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)

Time Frame

baseline, 96 weeks

Title

Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase

Description

Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)

Time Frame

baseline, 96 weeks

Title

Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase

Description

Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)

Time Frame

baseline, 96 weeks

Title

Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase

Description

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Time Frame

baseline, 8 weeks

Title

Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase

Description

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Time Frame

baseline, 16 weeks

Title

Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase

Description

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Time Frame

baseline, 32 weeks

Title

Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase

Description

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Time Frame

baseline, 48 weeks

Title

Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase

Description

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Time Frame

baseline, 64 weeks

Title

Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase

Description

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Time Frame

baseline, 80 weeks

Title

Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase

Description

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Time Frame

baseline, 96 weeks

Title

Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase

Description

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Time Frame

baseline, 8 weeks

Title

Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase

Description

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Time Frame

baseline, 16 weeks

Title

Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase

Description

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Time Frame

baseline, 32 weeks

Title

Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase

Description

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Time Frame

baseline, 48 weeks

Title

Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase

Description

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Time Frame

baseline, 64 weeks

Title

Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase

Description

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Time Frame

baseline, 80 weeks

Title

Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase

Description

The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

Time Frame

baseline, 96 weeks

Title

Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase

Description

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Time Frame

baseline, 96 weeks

Title

Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase

Description

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Time Frame

baseline, 96 weeks

Title

Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase

Description

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Time Frame

baseline, 96 weeks

Title

Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase

Description

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Time Frame

baseline, 96 weeks

Title

Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase

Description

COPD exacerbation is a complex of symptoms related to COPD with a duration of three days or more requiring a change of treatment.

Time Frame

baseline, 96 weeks

Title

90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase

Description

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Time Frame

baseline, 100 weeks

Title

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase

Description

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time Frame

baseline, 100 weeks

Title

Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase

Description

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time Frame

baseline, 100 weeks

Title

Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase

Description

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Time Frame

baseline, 100 weeks

Title

Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase

Description

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Time Frame

baseline, 100 weeks

Title

Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase

Description

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Time Frame

baseline, 100 weeks

Title

Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase

Description

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Time Frame

baseline, 100 weeks

Title

Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status

Description

Clinical Relevant Abnormalities for Vital Signs and Physical examination, including vital status. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.

Time Frame

From first drug administration until 30 days after last drug administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria All patients must sign an informed consent Diagnosis of COPD with specific spirometric criteria (determined at study visits) Age >= 40 years Medical Research Council Dyspnoea score >= 2 Current or ex-smoker with a >= 10 pack-year smoking history Ability to exercise on treadmill Exclusion criteria Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment Clinical history of asthma Use of supplemental oxygen therapy Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery) Recent history (<= 12 months) of myocardial infarction Unstable or life-threatening cardiac arrhythmia Malignancy treated with radiation therapy or chemotherapy in the last 5 years Pregnant or nursing women Known hypersensitivity to anticholinergic drugs or any component of the study medications Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1 Estimated life expectancy < 2 years Symptomatic prostatic hyperplasia or bladder neck obstruction Known narrow-angle glaucoma Any condition that is contraindicated for exercise Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing Body mass index < 18 kg/m2 or >35 kg/m2 list truncated for space

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

205.368.01023 Boehringer Ingelheim Investigational Site

City

Jasper

State/Province

Alabama

Country

United States

Facility Name

205.368.01022 Boehringer Ingelheim Investigational Site

City

Phoenix

State/Province

Arizona

Country

United States

Facility Name

205.368.01003 Boehringer Ingelheim Investigational Site

City

Los Angeles

State/Province

California

Country

United States

Facility Name

205.368.01008 Boehringer Ingelheim Investigational Site

City

Fort Collins

State/Province

Colorado

Country

United States

Facility Name

205.368.01017 Boehringer Ingelheim Investigational Site

City

Hartford

State/Province

Connecticut

Country

United States

Facility Name

205.368.01028 Boehringer Ingelheim Investigational Site

City

Waterbury

State/Province

Connecticut

Country

United States

Facility Name

205.368.01004 Boehringer Ingelheim Investigational Site

City

Bay Pines

State/Province

Florida

Country

United States

Facility Name

205.368.01013 Boehringer Ingelheim Investigational Site

City

North Miami Beach

State/Province

Florida

Country

United States

Facility Name

205.368.01025 Boehringer Ingelheim Investigational Site

City

Hazard

State/Province

Kentucky

Country

United States

Facility Name

205.368.01029 Boehringer Ingelheim Investigational Site

City

Biddeford

State/Province

Maine

Country

United States

Facility Name

205.368.01016 Boehringer Ingelheim Investigational Site

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

205.368.01002 Boehringer Ingelheim Investigational Site

City

Boston

State/Province

Massachusetts

Country

United States

Facility Name

205.368.01021 Boehringer Ingelheim Investigational Site

City

Kansas City

State/Province

Missouri

Country

United States

Facility Name

205.368.01014 Boehringer Ingelheim Investigational Site

City

Albany

State/Province

New York

Country

United States

Facility Name

205.368.01030 Boehringer Ingelheim Investigational Site

City

Tulsa

State/Province

Oklahoma

Country

United States

Facility Name

205.368.01018 Boehringer Ingelheim Investigational Site

City

Charleston

State/Province

South Carolina

Country

United States

Facility Name

205.368.01027 Boehringer Ingelheim Investigational Site

City

Gaffney

State/Province

South Carolina

Country

United States

Facility Name

205.368.01019 Boehringer Ingelheim Investigational Site

City

Greenville

State/Province

South Carolina

Country

United States

Facility Name

205.368.01020 Boehringer Ingelheim Investigational Site

City

Spartanburg

State/Province

South Carolina

Country

United States

Facility Name

205.368.01024 Boehringer Ingelheim Investigational Site

City

Union

State/Province

South Carolina

Country

United States

Facility Name

205.368.01015 Boehringer Ingelheim Investigational Site

City

Dallas

State/Province

Texas

Country

United States

Facility Name

205.368.54001 Boehringer Ingelheim Investigational Site

City

Rosario

Country

Argentina

Facility Name

205.368.54002 Boehringer Ingelheim Investigational Site

City

Vicente López

Country

Argentina

Facility Name

205.368.55003 Boehringer Ingelheim Investigational Site

City

Goiânia

Country

Brazil

Facility Name

205.368.55004 Boehringer Ingelheim Investigational Site

City

Porto Alegre - RS

Country

Brazil

Facility Name

205.368.55002 Boehringer Ingelheim Investigational Site

City

Sao Paulo

Country

Brazil

Facility Name

205.368.07006 Boehringer Ingelheim Investigational Site

City

Vancouver

State/Province

British Columbia

Country

Canada

Facility Name

205.368.07001 Boehringer Ingelheim Investigational Site

City

Winnipeg

State/Province

Manitoba

Country

Canada

Facility Name

205.368.07003 Boehringer Ingelheim Investigational Site

City

Winnipeg

State/Province

Manitoba

Country

Canada

Facility Name

205.368.07004 Boehringer Ingelheim Investigational Site

City

Hamilton

State/Province

Ontario

Country

Canada

Facility Name

205.368.07005 Boehringer Ingelheim Investigational Site

City

Hamilton

State/Province

Ontario

Country

Canada

Facility Name

205.368.07008 Boehringer Ingelheim Investigational Site

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

205.368.49005 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

205.368.49004 Boehringer Ingelheim Investigational Site

City

Freiburg/Breisgau

Country

Germany

Facility Name

205.368.49003 Boehringer Ingelheim Investigational Site

City

Köln

Country

Germany

Facility Name

205.368.49006 Boehringer Ingelheim Investigational Site

City

Münster

Country

Germany

Facility Name

205.368.49002 Boehringer Ingelheim Investigational Site

City

Schmallenberg

Country

Germany

Facility Name

205.368.49001 Boehringer Ingelheim Investigational Site

City

Tübingen

Country

Germany

Facility Name

205.368.39006 Boehringer Ingelheim Investigational Site

City

Ferrara

Country

Italy

Facility Name

205.368.39004 Boehringer Ingelheim Investigational Site

City

Milano

Country

Italy

Facility Name

205.368.39002 Boehringer Ingelheim Investigational Site

City

Parma

Country

Italy

Facility Name

205.368.39001 Boehringer Ingelheim Investigational Site

City

Pisa

Country

Italy

Facility Name

205.368.35103 Boehringer Ingelheim Investigational Site

City

Coimbra

Country

Portugal

Facility Name

205.368.35102 Boehringer Ingelheim Investigational Site

City

Matosinhos

Country

Portugal

Facility Name

205.368.70001 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

205.368.70004 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

205.368.70005 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

205.368.70006 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

205.368.70007 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

205.368.34005 Hospital Germans Trias i Pujol

City

Badalona (Barcelona)

Country

Spain

Facility Name

205.368.34002 Hospital de Cruces

City

Barakaldo (Bilbao)

Country

Spain

Facility Name

205.368.34001 Hospital Clinic i Provincial de Barcelona

City

Barcelona

Country

Spain

Facility Name

205.368.34003 Hospital Gregorio Maranon

City

Madrid

Country

Spain

Facility Name

205.368.34004 Hospital Universitario Vírgen del Rocío

City

Sevilla

Country

Spain

Facility Name

205.368.34006 Boehringer Ingelheim Investigational Site

City

Sevilla

Country

Spain

Facility Name

205.368.88604 Boehringer Ingelheim Investigational Site

City

Keelung

Country

Taiwan

Facility Name

205.368.88602 Boehringer Ingelheim Investigational Site

City

Taichung

Country

Taiwan

Facility Name

205.368.88603 Boehringer Ingelheim Investigational Site

City

Taipei City

Country

Taiwan

Facility Name

205.368.88601 Chang Gung Memorial Hosp-Linkou

City

Taoyuan

Country

Taiwan

Facility Name

205.368.38003 Boehringer Ingelheim Investigational Site

City

Dnyepropyetrovsk

Country

Ukraine

Facility Name

205.368.38001 Boehringer Ingelheim Investigational Site

City

Kiev

Country

Ukraine

Facility Name

205.368.38002 Boehringer Ingelheim Investigational Site

City

Kiev

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

23558890

Citation

Cooper CB, Celli BR, Jardim JR, Wise RA, Legg D, Guo J, Kesten S. Treadmill endurance during 2-year treatment with tiotropium in patients with COPD: a randomized trial. Chest. 2013 Aug;144(2):490-497. doi: 10.1378/chest.12-2613.

Results Reference

derived

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.368_U11-3094.pdf

Description

Related Info

Learn more about this trial

Tiotropium In Exercise

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Tiotropium In Exercise

Pulmonary Disease, Chronic Obstructive, Exercise

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial