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Tiotropium/Salmeterol Inhalation Powder (Spiriva Handihaler and Salmeterol Polyethylene (PE) Capsule) in Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Tiotropium/Salmeterol QD

Placebo

Salmeterol

Tiotropium/Salmeterol QD+ Salmeterol

Tiotropium (Spiriva®)

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:

Main:

Diagnosis of COPD Post-bronchodilator FEV1<80% predicted and FEV1/FVC<70% predicted

Exclusion criteria:

Main:

Significant other diseases then COPD Recent MI Unstable or life-threatening arrythmia requiring intervention or change in drug therapy Hospitalisation for cardiac failure in past year History of asthma

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Tiotropium/Salmeterol quaque die (QD, once daily)

Tiotropium quaque die (QD, once daily)

Salmeterol bis in die (BID, twice daily)

Tiotropium/Salmeterol quaque die (QD, once daily)+ Salmeterol

Placebo

Arm Description

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule

Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)

Salmeterol Inhalation Powder, hard PE capsule

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule

Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule

Outcomes

Primary Outcome Measures

Trough forced expiratory volume in one second (FEV1) response

FEV1 area under the curve (AUC) 0-8h response

Mahler Transition Dyspnoea Index (TDI) focal score

St George Respiratory Questionnaire (SGRQ) total score

Time to first moderate to severe COPD exacerbation

Secondary Outcome Measures

FEV1 AUC 0-8h response

Trough FEV1 response

Peak FEV1 response

Use of rescue medication (weekly mean number of puffs of as-needed salbutamol/albuterol per day, daytime and night-time)

Forced vital capacity (FVC) AUC0-8h and trough FVC response

Individual FEV1, FVC and peak expiratory flow (PEF) measurements

Weekly mean morning pre-dose and evening pre-dose PEFs and FEV1 (recorded by Asthma Monitor® 2 (AM2+)); PEFs determined by spirometry ]

Weekly mean number of COPD related night time awakenings

Mahler TDI focal score

Mahler Dyspnoea Indices (Functional Impairment, Magnitude of Task and Magnitude of Effort)

SGRQ total score, and the impact, activity and symptoms domain scores from the SGRQ

All adverse events

Vital signs: pulse rate and blood pressure

Routine blood chemistry, haematology and urinalysis

Vital status of randomised patients

Number of days in hospital (including ambulance transportation

Number of unscheduled health care provider visits

Number of visits in emergency room (including ambulance transportation)

Number of days in intensive care unit

Concomitant medications (for instance antibiotics and systemic steroids).

Full Information

NCT ID

NCT00662740

First Posted

April 17, 2008

Last Updated

August 18, 2023

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00662740

Brief Title

Tiotropium/Salmeterol Inhalation Powder (Spiriva Handihaler and Salmeterol Polyethylene (PE) Capsule) in Chronic Obstructive Pulmonary Disease (COPD)

Official Title

1-yr Study Comparing TioSal Combo Regimens Versus Single Agent Therapies (Spiriva HandiHaler and Salmeterol PE Capsule)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Terminated

Study Start Date

April 15, 2008 (Actual)

Primary Completion Date

November 21, 2008 (Actual)

Study Completion Date

November 21, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

The primary objectives of this study are to assess bronchodilator efficacy as determined by forced expiratory volume in one second (FEV1), the effect on dyspnoea as determined by the Baseline Dyspnoea Index/Transition Dyspnoea Index (BDI/TDI), the effect on health status as determined by the St George Respiratory Questionnaire (SGRQ) and the effect on chronic obstructive pulmonary disease (COPD) exacerbations.

6. Conditions and Keywords

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

Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

220 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tiotropium/Salmeterol quaque die (QD, once daily)

Arm Type

Experimental

Arm Description

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule

Arm Title

Tiotropium quaque die (QD, once daily)

Arm Type

Active Comparator

Arm Description

Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)

Arm Title

Salmeterol bis in die (BID, twice daily)

Arm Type

Active Comparator

Arm Description

Salmeterol Inhalation Powder, hard PE capsule

Arm Title

Tiotropium/Salmeterol quaque die (QD, once daily)+ Salmeterol

Arm Type

Active Comparator

Arm Description

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule

Intervention Type

Drug

Intervention Name(s)

Tiotropium/Salmeterol QD

Intervention Description

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule

Intervention Type

Drug

Intervention Name(s)

Salmeterol

Intervention Description

Salmeterol Inhalation Powder, hard PE capsule

Intervention Type

Drug

Intervention Name(s)

Tiotropium/Salmeterol QD+ Salmeterol

Intervention Description

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule

Intervention Type

Drug

Intervention Name(s)

Tiotropium (Spiriva®)

Intervention Description

Tiotropium, Spiriva®

Primary Outcome Measure Information:

Title

Trough forced expiratory volume in one second (FEV1) response

Time Frame