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A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
tiotropium
Combivent (Ipratropium/Albuterol)
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

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: Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Age: greater than or equal to 40 years Current or ex-smoker with a >= 10 pack-year smoking history Use of Combivent® Metered Dose Inhaler (MDI)for >= 1 month prior to Visit 1 Spirometric criteria (determined at study visits): Post-bronchodilator Forced Expiratory Volume in one second (FEV1) <= 70% (Visit 1) Pre-bronchodilator FEV1 <= 65% of predicted and FEV1/Forced Vital Capacity (FVC) <= 70% (Visit 2) Exclusion Criteria: Clinical history of asthma History of thoracotomy with pulmonary resection History of Cystic Fibrosis, alpha 1 antitrypsin deficiency or interstitial lung disease Daytime use of oxygen therapy for > 1 hour per day or if unable to abstain fr om using oxygen during Pulmonary Function Tests Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1 Recent history 6 months or less of Myocardial Infarction Unstable or life-threatening cardiac arrhythmias Hospitalization for Congestive Heart Failure during past year Malignancy for which patient is receiving chemo or radiation therapy Pregnant or nursing women Known hypersensitivity to ipratropium or carrier substances, including related food products such as soybean, peanuts, or lactose Use of SPIRIVA® 3 months prior to Visit 1 Symptomatic of prostatic hypertrophy or bladder neck obstruction Known narrow- angle glaucoma Participating in a pulmonary rehab program within 4 weeks of Visit 1

Sites / Locations

  • 205.325.904 Boehringer Ingelheim Investigational Site
  • 205.325.925 Boehringer Ingelheim Investigational Site
  • 205.325.909 Boehringer Ingelheim Investigational Site
  • 205.325.912 Boehringer Ingelheim Investigational Site
  • 205.325.911 Boehringer Ingelheim Investigational Site
  • 205.325.935 Boehringer Ingelheim Investigational Site
  • 205.325.903 Boehringer Ingelheim Investigational Site
  • 205.325.905 Boehringer Ingelheim Investigational Site
  • 205.325.922 Boehringer Ingelheim Investigational Site
  • 205.325.907 Boehringer Ingelheim Investigational Site
  • 205.325.928 Boehringer Ingelheim Investigational Site
  • 205.325.923 Boehringer Ingelheim Investigational Site
  • 205.325.902 Boehringer Ingelheim Investigational Site
  • 205.325.908 Boehringer Ingelheim Investigational Site
  • 205.325.920 Boehringer Ingelheim Investigational Site
  • 205.325.932 Boehringer Ingelheim Investigational Site
  • 205.325.915 Boehringer Ingelheim Investigational Site
  • 205.325.914 Boehringer Ingelheim Investigational Site
  • 205.325.910 Boehringer Ingelheim Investigational Site
  • 205.325.924 Boehringer Ingelheim Investigational Site
  • 205.325.921 Boehringer Ingelheim Investigational Site
  • 205.325.917 Boehringer Ingelheim Investigational Site
  • 205.325.926 Boehringer Ingelheim Investigational Site
  • 205.325.901 Boehringer Ingelheim Investigational Site
  • 205.325.931 Boehringer Ingelheim Investigational Site
  • 205.325.929 Boehringer Ingelheim Investigational Site
  • 205.325.936 Boehringer Ingelheim Investigational Site
  • 205.325.918 Boehringer Ingelheim Investigational Site
  • 205.325.927 Boehringer Ingelheim Investigational Site
  • 205.325.919 Boehringer Ingelheim Investigational Site
  • 205.325.906 Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks
Trough FEV1 is measured 10 minutes before drug administration
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks
Average hourly FEV1 AUC0-6 minus baseline FEV1

Secondary Outcome Measures

Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks
Trough FEV1 is measured 10 minutes before drug administration
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1
Average hourly FEV1 AUC0-6 minus baseline FEV1
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6
Average hourly FEV1 AUC0-6 minus baseline FEV1
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1
Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6
Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12
Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication
Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks
Trough FVC is measured 10 minutes before drug administration
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks
Average hourly FVC AUC0-6 minus baseline FVC
Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks
Trough FVC is measured 10 minutes before drug administration
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1
Average hourly FVC AUC0-6 minus baseline FVC
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks
Average hourly FVC AUC0-6 minus baseline FVC
Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1
Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6
Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12
Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication
FEV1 at 15 Minutes on Day 1
FEV1 at 30 Minutes on Day 1
FEV1 at 1 Hour on Day 1
FEV1 at 2 Hours on Day 1
FEV1 at 3 Hours on Day 1
FEV1 at 4 Hours on Day 1
FEV1 at 6 Hours on Day 1
FEV1 at -10 Minutes at Week 6
FEV1 at 15 Minutes at Week 6
FEV1 at 30 Minutes at Week 6
FEV1 at 1 Hour at Week 6
FEV1 at 2 Hours at Week 6
FEV1 at 3 Hours at Week 6
FEV1 at 4 Hours at Week 6
FEV1 at 6 Hours at Week 6
FEV1 at -10 Minutes at Week 12
FEV1 at 15 Minutes at Week 12
FEV1 at 30 Minutes at Week 12
FEV1 at 1 Hour at Week 12
FEV1 at 2 Hours at Week 12
FEV1 at 3 Hours at Week 12
FEV1 at 4 Hours at Week 12
FEV1 at 6 Hours at Week 12
FVC at 15 Minutes on Day 1
FVC at 30 Minutes on Day 1
FVC at 1 Hour on Day 1
FVC at 2 Hours on Day 1
FVC at 3 Hours on Day 1
FVC at 4 Hours on Day 1
FVC at 6 Hours on Day 1
FVC at -10 Minutes at Week 6
FVC at 15 Minutes at Week 6
FVC at 30 Minutes at Week 6
FVC at 1 Hour at Week 6
FVC at 2 Hours at Week 6
FVC at 3 Hours at Week 6
FVC at 4 Hours at Week 6
FVC at 6 Hours at Week 6
FVC at -10 Minutes at Week 12
FVC at 15 Minutes at Week 12
FVC at 30 Minutes at Week 12
FVC at 1 Hour at Week 12
FVC at 2 Hours at Week 12
FVC at 3 Hours at Week 12
FVC at 4 Hours at Week 12
FVC at 6 Hours at Week 12
Day Time Albuterol Use During Week 1
Puffs of rescue albuterol used during the day in week 1
Day Time Albuterol Use During Week 2
Puffs of rescue albuterol used during the day in week 2
Day Time Albuterol Use During Week 3
Puffs of rescue albuterol used during the day in week 3
Day Time Albuterol Use During Week 4
Puffs of rescue albuterol used during the day in week 4
Day Time Albuterol Use During Week 5
Puffs of rescue albuterol used during the day in week 5
Day Time Albuterol Use During Week 6
Puffs of rescue albuterol used during the day in week 6
Day Time Albuterol Use During Week 7
Puffs of rescue albuterol used during the day in week 7
Day Time Albuterol Use During Week 8
Puffs of rescue albuterol used during the day in week 8
Day Time Albuterol Use During Week 9
Puffs of rescue albuterol used during the day in week 9
Day Time Albuterol Use During Week 10
Puffs of rescue albuterol used during the day in week 10
Day Time Albuterol Use During Week 11
Puffs of rescue albuterol used during the day in week 11
Day Time Albuterol Use During Week 12
Puffs of rescue albuterol used during the day in week 12
Night Time Albuterol Use During Week 1
Night Time Albuterol Use During Week 2
Puffs of rescue albuterol used during the night in week 2
Night Time Albuterol Use During Week 3
Puffs of rescue albuterol used during the night in week 3
Night Time Albuterol Use During Week 4
Puffs of rescue albuterol used during the night in week 4
Night Time Albuterol Use During Week 5
Puffs of rescue albuterol used during the night in week 5
Night Time Albuterol Use During Week 6
Puffs of rescue albuterol used during the night in week 6
Night Time Albuterol Use During Week 7
Puffs of rescue albuterol used during the night in week 7
Night Time Albuterol Use During Week 8
Puffs of rescue albuterol used during the night in week 8
Night Time Albuterol Use During Week 9
Puffs of rescue albuterol used during the night in week 9
Night Time Albuterol Use During Week 10
Puffs of rescue albuterol used during the night in week 10
Night Time Albuterol Use During Week 11
Puffs of rescue albuterol used during the night in week 11
Night Time Albuterol Use During Week 12
Puffs of rescue albuterol used during the night in week 12
Morning Peak Expiratory Flow Rate (PEFR) at Week 1
Morning PEFR at Week 2
Weekly means for morning PEFR
Morning PEFR at Week 3
Weekly means for morning PEFR
Morning PEFR at Week 4
Weekly means for morning PEFR
Morning PEFR at Week 5
Weekly means for morning PEFR
Morning PEFR at Week 6
Weekly means for morning PEFR
Morning PEFR at Week 7
Weekly means for morning PEFR
Morning PEFR at Week 8
Weekly means for morning PEFR
Morning PEFR at Week 9
Weekly means for morning PEFR
Morning PEFR at Week 10
Weekly means for morning PEFR
Morning PEFR at Week 11
Weekly means for morning PEFR
Morning PEFR at Week 12
Weekly means for morning PEFR
Evening PEFR at Week 1
Weekly means for evening PEFR
Evening PEFR at Week 2
Weekly means for evening PEFR
Evening PEFR at Week 3
Weekly means for evening PEFR
Evening PEFR at Week 4
Weekly means for evening PEFR
Evening PEFR at Week 5
Weekly means for evening PEFR
Evening PEFR at Week 6
Weekly means for evening PEFR
Evening PEFR at Week 7
Weekly means for evening PEFR
Evening PEFR at Week 8
Weekly means for evening PEFR
Evening PEFR at Week 9
Weekly means for evening PEFR
Evening PEFR at Week 10
Weekly means for evening PEFR
Evening PEFR at Week 11
Weekly means for evening PEFR
Evening PEFR at Week 12
Weekly means for evening PEFR
Patient Global Evaluation
The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to chronic obstructive pulmonary disease (COPD). The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8)
Patient Global Evaluation
The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).
Physician Global Evaluation
The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).
Physician Global Evaluation
The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).

Full Information

First Posted
August 1, 2006
Last Updated
May 7, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00359788
Brief Title
A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.
Official Title
A Randomized, Double-blind, Parallel Group Trial Comparing 12 Weeks Treatment With Tiotropium 18 mcg Daily to Combivent MDI 2 Actuations Qid in COPD Patients Previously Prescribed Combivent MDI
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler (MDI) Chlorofluorocarbon Inhalation Aerosol 2 actuations four times a day in Chronic Obstructive Pulmonary Disease (COPD) patients currently prescribed Combivent® MDI.

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 4
Interventional Study Model
Parallel Assignment
Enrollment
349 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tiotropium
Intervention Type
Drug
Intervention Name(s)
Combivent (Ipratropium/Albuterol)
Primary Outcome Measure Information:
Title
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks
Description
Trough FEV1 is measured 10 minutes before drug administration
Time Frame
Baseline and 12 Weeks
Title
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks
Description
Average hourly FEV1 AUC0-6 minus baseline FEV1
Time Frame
Baseline and 12 Weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks
Description
Trough FEV1 is measured 10 minutes before drug administration
Time Frame
Baseline and 6 Weeks
Title
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1
Description
Average hourly FEV1 AUC0-6 minus baseline FEV1
Time Frame
Day 1 (after first dose)
Title
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6
Description
Average hourly FEV1 AUC0-6 minus baseline FEV1
Time Frame
Baseline and week 6
Title
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1
Description
Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication
Time Frame
Day 1
Title
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6
Description
Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication
Time Frame
Baseline and 6 weeks
Title
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12
Description
Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks
Description
Trough FVC is measured 10 minutes before drug administration
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks
Description
Average hourly FVC AUC0-6 minus baseline FVC
Time Frame
Baseline and 12 Weeks
Title
Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks
Description
Trough FVC is measured 10 minutes before drug administration
Time Frame
Baseline and 6 weeks
Title
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1
Description
Average hourly FVC AUC0-6 minus baseline FVC
Time Frame
Day 1
Title
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks
Description
Average hourly FVC AUC0-6 minus baseline FVC
Time Frame
Baseline and 6 Weeks
Title
Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1
Description
Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication
Time Frame
Day 1
Title
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6
Description
Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication
Time Frame
baseline and 6 Weeks (after first dose)
Title
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12
Description
Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication
Time Frame
Baseline and 12 Weeks
Title
FEV1 at 15 Minutes on Day 1
Time Frame
15 minutes
Title
FEV1 at 30 Minutes on Day 1
Time Frame
30 minutes
Title
FEV1 at 1 Hour on Day 1
Time Frame
1 hour
Title
FEV1 at 2 Hours on Day 1
Time Frame
2 hour
Title
FEV1 at 3 Hours on Day 1
Time Frame
3 hour
Title
FEV1 at 4 Hours on Day 1
Time Frame
4 hour
Title
FEV1 at 6 Hours on Day 1
Time Frame
6 hours
Title
FEV1 at -10 Minutes at Week 6
Time Frame
10 minutes before dosing
Title
FEV1 at 15 Minutes at Week 6
Time Frame
15 minutes
Title
FEV1 at 30 Minutes at Week 6
Time Frame
30 minutes
Title
FEV1 at 1 Hour at Week 6
Time Frame
1 hour
Title
FEV1 at 2 Hours at Week 6
Time Frame
2 hour
Title
FEV1 at 3 Hours at Week 6
Time Frame
3 hour
Title
FEV1 at 4 Hours at Week 6
Time Frame
4 hour
Title
FEV1 at 6 Hours at Week 6
Time Frame
6 hour
Title
FEV1 at -10 Minutes at Week 12
Time Frame
10 minutes before dosing
Title
FEV1 at 15 Minutes at Week 12
Time Frame
15 minutes
Title
FEV1 at 30 Minutes at Week 12
Time Frame
30 minutes
Title
FEV1 at 1 Hour at Week 12
Time Frame
1 hour
Title
FEV1 at 2 Hours at Week 12
Time Frame
2 hour
Title
FEV1 at 3 Hours at Week 12
Time Frame
3 hour
Title
FEV1 at 4 Hours at Week 12
Time Frame
4 hour
Title
FEV1 at 6 Hours at Week 12
Time Frame
6 hour
Title
FVC at 15 Minutes on Day 1
Time Frame
15 minutes
Title
FVC at 30 Minutes on Day 1
Time Frame
30 minutes
Title
FVC at 1 Hour on Day 1
Time Frame
1 hour
Title
FVC at 2 Hours on Day 1
Time Frame
2 hour
Title
FVC at 3 Hours on Day 1
Time Frame
3 hour
Title
FVC at 4 Hours on Day 1
Time Frame
4 hour
Title
FVC at 6 Hours on Day 1
Time Frame
6 hour
Title
FVC at -10 Minutes at Week 6
Time Frame
10 minutes before dosing
Title
FVC at 15 Minutes at Week 6
Time Frame
15 minutes
Title
FVC at 30 Minutes at Week 6
Time Frame
30 minutes
Title
FVC at 1 Hour at Week 6
Time Frame
1 hour
Title
FVC at 2 Hours at Week 6
Time Frame
2 hour
Title
FVC at 3 Hours at Week 6
Time Frame
3 hour
Title
FVC at 4 Hours at Week 6
Time Frame
4 hour
Title
FVC at 6 Hours at Week 6
Time Frame
6 hour
Title
FVC at -10 Minutes at Week 12
Time Frame
10 minutes before dosing
Title
FVC at 15 Minutes at Week 12
Time Frame
15 minutes
Title
FVC at 30 Minutes at Week 12
Time Frame
30 minutes
Title
FVC at 1 Hour at Week 12
Time Frame
1 hour
Title
FVC at 2 Hours at Week 12
Time Frame
2 hour
Title
FVC at 3 Hours at Week 12
Time Frame
3 hour
Title
FVC at 4 Hours at Week 12
Time Frame
4 hour
Title
FVC at 6 Hours at Week 12
Time Frame
6 hour
Title
Day Time Albuterol Use During Week 1
Description
Puffs of rescue albuterol used during the day in week 1
Time Frame
Week 1
Title
Day Time Albuterol Use During Week 2
Description
Puffs of rescue albuterol used during the day in week 2
Time Frame
Week 2
Title
Day Time Albuterol Use During Week 3
Description
Puffs of rescue albuterol used during the day in week 3
Time Frame
Week 3
Title
Day Time Albuterol Use During Week 4
Description
Puffs of rescue albuterol used during the day in week 4
Time Frame
Week 4
Title
Day Time Albuterol Use During Week 5
Description
Puffs of rescue albuterol used during the day in week 5
Time Frame
Week 5
Title
Day Time Albuterol Use During Week 6
Description
Puffs of rescue albuterol used during the day in week 6
Time Frame
Week 6
Title
Day Time Albuterol Use During Week 7
Description
Puffs of rescue albuterol used during the day in week 7
Time Frame
Week 7
Title
Day Time Albuterol Use During Week 8
Description
Puffs of rescue albuterol used during the day in week 8
Time Frame
Week 8
Title
Day Time Albuterol Use During Week 9
Description
Puffs of rescue albuterol used during the day in week 9
Time Frame
Week 9
Title
Day Time Albuterol Use During Week 10
Description
Puffs of rescue albuterol used during the day in week 10
Time Frame
Week 10
Title
Day Time Albuterol Use During Week 11
Description
Puffs of rescue albuterol used during the day in week 11
Time Frame
Week 11
Title
Day Time Albuterol Use During Week 12
Description
Puffs of rescue albuterol used during the day in week 12
Time Frame
Week 12
Title
Night Time Albuterol Use During Week 1
Time Frame
Week 1
Title
Night Time Albuterol Use During Week 2
Description
Puffs of rescue albuterol used during the night in week 2
Time Frame
Week 2
Title
Night Time Albuterol Use During Week 3
Description
Puffs of rescue albuterol used during the night in week 3
Time Frame
Week 3
Title
Night Time Albuterol Use During Week 4
Description
Puffs of rescue albuterol used during the night in week 4
Time Frame
Week 4
Title
Night Time Albuterol Use During Week 5
Description
Puffs of rescue albuterol used during the night in week 5
Time Frame
Week 5
Title
Night Time Albuterol Use During Week 6
Description
Puffs of rescue albuterol used during the night in week 6
Time Frame
Week 6
Title
Night Time Albuterol Use During Week 7
Description
Puffs of rescue albuterol used during the night in week 7
Time Frame
Week 7
Title
Night Time Albuterol Use During Week 8
Description
Puffs of rescue albuterol used during the night in week 8
Time Frame
Week 8
Title
Night Time Albuterol Use During Week 9
Description
Puffs of rescue albuterol used during the night in week 9
Time Frame
Week 9
Title
Night Time Albuterol Use During Week 10
Description
Puffs of rescue albuterol used during the night in week 10
Time Frame
Week 10
Title
Night Time Albuterol Use During Week 11
Description
Puffs of rescue albuterol used during the night in week 11
Time Frame
Week 11
Title
Night Time Albuterol Use During Week 12
Description
Puffs of rescue albuterol used during the night in week 12
Time Frame
Week 12
Title
Morning Peak Expiratory Flow Rate (PEFR) at Week 1
Time Frame
Week 1
Title
Morning PEFR at Week 2
Description
Weekly means for morning PEFR
Time Frame
Week 2
Title
Morning PEFR at Week 3
Description
Weekly means for morning PEFR
Time Frame
Week 3
Title
Morning PEFR at Week 4
Description
Weekly means for morning PEFR
Time Frame
Week 4
Title
Morning PEFR at Week 5
Description
Weekly means for morning PEFR
Time Frame
Week 5
Title
Morning PEFR at Week 6
Description
Weekly means for morning PEFR
Time Frame
Week 6
Title
Morning PEFR at Week 7
Description
Weekly means for morning PEFR
Time Frame
Week 7
Title
Morning PEFR at Week 8
Description
Weekly means for morning PEFR
Time Frame
Week 8
Title
Morning PEFR at Week 9
Description
Weekly means for morning PEFR
Time Frame
Week 9
Title
Morning PEFR at Week 10
Description
Weekly means for morning PEFR
Time Frame
Week 10
Title
Morning PEFR at Week 11
Description
Weekly means for morning PEFR
Time Frame
Week 11
Title
Morning PEFR at Week 12
Description
Weekly means for morning PEFR
Time Frame
Week 12
Title
Evening PEFR at Week 1
Description
Weekly means for evening PEFR
Time Frame
Week 1
Title
Evening PEFR at Week 2
Description
Weekly means for evening PEFR
Time Frame
Week 2
Title
Evening PEFR at Week 3
Description
Weekly means for evening PEFR
Time Frame
Week 3
Title
Evening PEFR at Week 4
Description
Weekly means for evening PEFR
Time Frame
Week 4
Title
Evening PEFR at Week 5
Description
Weekly means for evening PEFR
Time Frame
Week 5
Title
Evening PEFR at Week 6
Description
Weekly means for evening PEFR
Time Frame
Week 6
Title
Evening PEFR at Week 7
Description
Weekly means for evening PEFR
Time Frame
Week 7
Title
Evening PEFR at Week 8
Description
Weekly means for evening PEFR
Time Frame
Week 8
Title
Evening PEFR at Week 9
Description
Weekly means for evening PEFR
Time Frame
Week 9
Title
Evening PEFR at Week 10
Description
Weekly means for evening PEFR
Time Frame
Week 10
Title
Evening PEFR at Week 11
Description
Weekly means for evening PEFR
Time Frame
Week 11
Title
Evening PEFR at Week 12
Description
Weekly means for evening PEFR
Time Frame
Week 12
Title
Patient Global Evaluation
Description
The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to chronic obstructive pulmonary disease (COPD). The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8)
Time Frame
Week 6
Title
Patient Global Evaluation
Description
The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).
Time Frame
Week 12
Title
Physician Global Evaluation
Description
The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).
Time Frame
Week 6
Title
Physician Global Evaluation
Description
The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Age: greater than or equal to 40 years Current or ex-smoker with a >= 10 pack-year smoking history Use of Combivent® Metered Dose Inhaler (MDI)for >= 1 month prior to Visit 1 Spirometric criteria (determined at study visits): Post-bronchodilator Forced Expiratory Volume in one second (FEV1) <= 70% (Visit 1) Pre-bronchodilator FEV1 <= 65% of predicted and FEV1/Forced Vital Capacity (FVC) <= 70% (Visit 2) Exclusion Criteria: Clinical history of asthma History of thoracotomy with pulmonary resection History of Cystic Fibrosis, alpha 1 antitrypsin deficiency or interstitial lung disease Daytime use of oxygen therapy for > 1 hour per day or if unable to abstain fr om using oxygen during Pulmonary Function Tests Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1 Recent history 6 months or less of Myocardial Infarction Unstable or life-threatening cardiac arrhythmias Hospitalization for Congestive Heart Failure during past year Malignancy for which patient is receiving chemo or radiation therapy Pregnant or nursing women Known hypersensitivity to ipratropium or carrier substances, including related food products such as soybean, peanuts, or lactose Use of SPIRIVA® 3 months prior to Visit 1 Symptomatic of prostatic hypertrophy or bladder neck obstruction Known narrow- angle glaucoma Participating in a pulmonary rehab program within 4 weeks of Visit 1
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
205.325.904 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
205.325.925 Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
205.325.909 Boehringer Ingelheim Investigational Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
205.325.912 Boehringer Ingelheim Investigational Site
City
Long Beach
State/Province
California
Country
United States
Facility Name
205.325.911 Boehringer Ingelheim Investigational Site
City
Palo Alto
State/Province
California
Country
United States
Facility Name
205.325.935 Boehringer Ingelheim Investigational Site
City
Fort Collins
State/Province
Colorado
Country
United States
Facility Name
205.325.903 Boehringer Ingelheim Investigational Site
City
West Haven
State/Province
Connecticut
Country
United States
Facility Name
205.325.905 Boehringer Ingelheim Investigational Site
City
Bay Pines
State/Province
Florida
Country
United States
Facility Name
205.325.922 Boehringer Ingelheim Investigational Site
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
205.325.907 Boehringer Ingelheim Investigational Site
City
North Chicago
State/Province
Illinois
Country
United States
Facility Name
205.325.928 Boehringer Ingelheim Investigational Site
City
Indiananapolis
State/Province
Indiana
Country
United States
Facility Name
205.325.923 Boehringer Ingelheim Investigational Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
205.325.902 Boehringer Ingelheim Investigational Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
205.325.908 Boehringer Ingelheim Investigational Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
205.325.920 Boehringer Ingelheim Investigational Site
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
205.325.932 Boehringer Ingelheim Investigational Site
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
205.325.915 Boehringer Ingelheim Investigational Site
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
205.325.914 Boehringer Ingelheim Investigational Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
205.325.910 Boehringer Ingelheim Investigational Site
City
Reno
State/Province
Nevada
Country
United States
Facility Name
205.325.924 Boehringer Ingelheim Investigational Site
City
East Orange
State/Province
New Jersey
Country
United States
Facility Name
205.325.921 Boehringer Ingelheim Investigational Site
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
205.325.917 Boehringer Ingelheim Investigational Site
City
Buffalo
State/Province
New York
Country
United States
Facility Name
205.325.926 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
205.325.901 Boehringer Ingelheim Investigational Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
205.325.931 Boehringer Ingelheim Investigational Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
205.325.929 Boehringer Ingelheim Investigational Site
City
Providence
State/Province
Rhode Island
Country
United States
Facility Name
205.325.936 Boehringer Ingelheim Investigational Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
205.325.918 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
205.325.927 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
205.325.919 Boehringer Ingelheim Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
205.325.906 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.325_U08-3661-01-DS.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.325_Literature.pdf
Description
Related Info

Learn more about this trial

A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.

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