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

Tracking Information

First Received Date ^ICMJE

August 1, 2006

Last Updated Date

November 12, 2009

Start Date ^ICMJE

July 2006

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks [ Time Frame: Baseline and 12 Weeks ]
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks [ Time Frame: Baseline and 12 Weeks ]

Original Primary Outcome Measures ^ICMJE

Trough and AUC0-6 FEV1 after 12 weeks.

Change History

Complete list of historical versions of study NCT00359788 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks [ Time Frame: Baseline and 6 Weeks ]
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1 [ Time Frame: Day 1 (after first dose) ]
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6 [ Time Frame: Baseline and week 6 ]
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1 [ Time Frame: Day 1 ]
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6 [ Time Frame: Baseline and 6 weeks ]
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12 [ Time Frame: Baseline and 12 weeks ]
Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks [ Time Frame: Baseline and 12 weeks ]
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks [ Time Frame: Baseline and 12 Weeks ]
Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks [ Time Frame: Baseline and 6 weeks ]
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1 [ Time Frame: Day 1 ]
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks [ Time Frame: Baseline and 6 Weeks ]
Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1 [ Time Frame: Day 1 ]
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6 [ Time Frame: baseline and 6 Weeks (after first dose) ]
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12 [ Time Frame: Baseline and 12 Weeks ]
FEV1 at 15 Minutes on Day 1 [ Time Frame: 15 minutes ]
FEV1 at 30 Minutes on Day 1 [ Time Frame: 30 minutes ]
FEV1 at 1 Hour on Day 1 [ Time Frame: 1 hour ]
FEV1 at 2 Hours on Day 1 [ Time Frame: 2 hour ]
FEV1 at 3 Hours on Day 1 [ Time Frame: 3 hour ]
FEV1 at 4 Hours on Day 1 [ Time Frame: 4 hour ]
FEV1 at 6 Hours on Day 1 [ Time Frame: 6 hours ]
FEV1 at -10 Minutes at Week 6 [ Time Frame: 10 minutes before dosing ]
FEV1 at 15 Minutes at Week 6 [ Time Frame: 15 minutes ]
FEV1 at 30 Minutes at Week 6 [ Time Frame: 30 minutes ]
FEV1 at 1 Hour at Week 6 [ Time Frame: 1 hour ]
FEV1 at 2 Hours at Week 6 [ Time Frame: 2 hour ]
FEV1 at 3 Hours at Week 6 [ Time Frame: 3 hour ]
FEV1 at 4 Hours at Week 6 [ Time Frame: 4 hour ]
FEV1 at 6 Hours at Week 6 [ Time Frame: 6 hour ]
FEV1 at -10 Minutes at Week 12 [ Time Frame: 10 minutes before dosing ]
FEV1 at 15 Minutes at Week 12 [ Time Frame: 15 minutes ]
FEV1 at 30 Minutes at Week 12 [ Time Frame: 30 minutes ]
FEV1 at 1 Hour at Week 12 [ Time Frame: 1 hour ]
FEV1 at 2 Hours at Week 12 [ Time Frame: 2 hour ]
FEV1 at 3 Hours at Week 12 [ Time Frame: 3 hour ]
FEV1 at 4 Hours at Week 12 [ Time Frame: 4 hour ]
FEV1 at 6 Hours at Week 12 [ Time Frame: 6 hour ]
FVC at 15 Minutes on Day 1 [ Time Frame: 15 minutes ]
FVC at 30 Minutes on Day 1 [ Time Frame: 30 minutes ]
FVC at 1 Hour on Day 1 [ Time Frame: 1 hour ]
FVC at 2 Hours on Day 1 [ Time Frame: 2 hour ]
FVC at 3 Hours on Day 1 [ Time Frame: 3 hour ]
FVC at 4 Hours on Day 1 [ Time Frame: 4 hour ]
FVC at 6 Hours on Day 1 [ Time Frame: 6 hour ]
FVC at -10 Minutes at Week 6 [ Time Frame: 10 minutes before dosing ]
FVC at 15 Minutes at Week 6 [ Time Frame: 15 minutes ]
FVC at 30 Minutes at Week 6 [ Time Frame: 30 minutes ]
FVC at 1 Hour at Week 6 [ Time Frame: 1 hour ]
FVC at 2 Hours at Week 6 [ Time Frame: 2 hour ]
FVC at 3 Hours at Week 6 [ Time Frame: 3 hour ]
FVC at 4 Hours at Week 6 [ Time Frame: 4 hour ]
FVC at 6 Hours at Week 6 [ Time Frame: 6 hour ]
FVC at -10 Minutes at Week 12 [ Time Frame: 10 minutes before dosing ]
FVC at 15 Minutes at Week 12 [ Time Frame: 15 minutes ]
FVC at 30 Minutes at Week 12 [ Time Frame: 30 minutes ]
FVC at 1 Hour at Week 12 [ Time Frame: 1 hour ]
FVC at 2 Hours at Week 12 [ Time Frame: 2 hour ]
FVC at 3 Hours at Week 12 [ Time Frame: 3 hour ]
FVC at 4 Hours at Week 12 [ Time Frame: 4 hour ]
FVC at 6 Hours at Week 12 [ Time Frame: 6 hour ]
Day Time Albuterol Use During Week 1 [ Time Frame: Week 1 ]
Day Time Albuterol Use During Week 2 [ Time Frame: Week 2 ]
Day Time Albuterol Use During Week 3 [ Time Frame: Week 3 ]
Day Time Albuterol Use During Week 4 [ Time Frame: Week 4 ]
Day Time Albuterol Use During Week 5 [ Time Frame: Week 5 ]
Day Time Albuterol Use During Week 6 [ Time Frame: Week 6 ]
Day Time Albuterol Use During Week 7 [ Time Frame: Week 7 ]
Day Time Albuterol Use During Week 8 [ Time Frame: Week 8 ]
Day Time Albuterol Use During Week 9 [ Time Frame: Week 9 ]
Day Time Albuterol Use During Week 10 [ Time Frame: Week 10 ]
Day Time Albuterol Use During Week 11 [ Time Frame: Week 11 ]
Day Time Albuterol Use During Week 12 [ Time Frame: Week 12 ]
Night Time Albuterol Use During Week 1 [ Time Frame: Week 1 ]
Night Time Albuterol Use During Week 2 [ Time Frame: Week 2 ]
Night Time Albuterol Use During Week 3 [ Time Frame: Week 3 ]
Night Time Albuterol Use During Week 4 [ Time Frame: Week 4 ]
Night Time Albuterol Use During Week 5 [ Time Frame: Week 5 ]
Night Time Albuterol Use During Week 6 [ Time Frame: Week 6 ]
Night Time Albuterol Use During Week 7 [ Time Frame: Week 7 ]
Night Time Albuterol Use During Week 8 [ Time Frame: Week 8 ]
Night Time Albuterol Use During Week 9 [ Time Frame: Week 9 ]
Night Time Albuterol Use During Week 10 [ Time Frame: Week 10 ]
Night Time Albuterol Use During Week 11 [ Time Frame: Week 11 ]
Night Time Albuterol Use During Week 12 [ Time Frame: Week 12 ]
Morning Peak Expiratory Flow Rate (PEFR) at Week 1 [ Time Frame: Week 1 ]
Morning PEFR at Week 2 [ Time Frame: Week 2 ]
Morning PEFR at Week 3 [ Time Frame: Week 3 ]
Morning PEFR at Week 4 [ Time Frame: Week 4 ]
Morning PEFR at Week 5 [ Time Frame: Week 5 ]
Morning PEFR at Week 6 [ Time Frame: Week 6 ]
Morning PEFR at Week 7 [ Time Frame: Week 7 ]
Morning PEFR at Week 8 [ Time Frame: Week 8 ]
Morning PEFR at Week 9 [ Time Frame: Week 9 ]
Morning PEFR at Week 10 [ Time Frame: Week 10 ]
Morning PEFR at Week 11 [ Time Frame: Week 11 ]
Morning PEFR at Week 12 [ Time Frame: Week 12 ]
Evening PEFR at Week 1 [ Time Frame: Week 1 ]
Evening PEFR at Week 2 [ Time Frame: Week 2 ]
Evening PEFR at Week 3 [ Time Frame: Week 3 ]
Evening PEFR at Week 1 [ Time Frame: Week 4 ]
Evening PEFR at Week 5 [ Time Frame: Week 5 ]
Evening PEFR at Week 6 [ Time Frame: Week 6 ]
Evening PEFR at Week 7 [ Time Frame: Week 7 ]
Evening PEFR at Week 8 [ Time Frame: Week 8 ]
Evening PEFR at Week 9 [ Time Frame: Week 9 ]
Evening PEFR at Week 10 [ Time Frame: Week 10 ]
Evening PEFR at Week 11 [ Time Frame: Week 11 ]
Evening PEFR at Week 12 [ Time Frame: Week 12 ]
Patient Global Evaluation [ Time Frame: Week 6 ]
Patient Global Evaluation [ Time Frame: Week 12 ]
Physician Global Evaluation [ Time Frame: Week 6 ]
Physician Global Evaluation [ Time Frame: Week 12 ]

Original Secondary Outcome Measures ^ICMJE

Peak FEV1, FVC (trough, peak, AUC0-6), FEV1 and FVC at each timepoint, trough FEV1 at 6 weeks, albuterol use, Patient and Physician Global Evaluations, daily PEFR

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Pulmonary Disease, Chronic Obstructive

Intervention ^ICMJE

Drug: tiotropium
Drug: Combivent (Ipratropium/Albuterol)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

349

Completion Date

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00359788

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Study ID Numbers ^ICMJE

205.325

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP