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A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.
This study has been completed.
First Received: August 1, 2006   Last Updated: November 12, 2009   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00359788
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
 Drug: tiotropium
Drug: Combivent (Ipratropium/Albuterol)
 Phase IV

Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Ataxia Telangiectasia COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for: Albuterol Ipratropium bromide Ipratropium Tiotropium bromide Tiotropium Combivent
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 349
Study Start Date: July 2006
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359788

  Show 31 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 205.325
Study First Received: August 1, 2006
Results First Received: April 17, 2009
Last Updated: November 12, 2009
ClinicalTrials.gov Identifier: NCT00359788     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parasympatholytics
Respiratory System Agents
Neurotransmitter Agents
Disease Attributes
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cholinergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive
 Pathologic Processes
Respiratory Tract Diseases
Ipratropium
Autonomic Agents
Therapeutic Uses
Lung Diseases
Chronic Disease
Peripheral Nervous System Agents
Tiotropium
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 08, 2010



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