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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00359788
First received: August 1, 2006
Last updated: May 7, 2014
Last verified: September 2013
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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 [ Time Frame: Day 1 (after first dose) ]
    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 [ Time Frame: Baseline and 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 [ Time Frame: 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 [ Time Frame: Baseline and 6 weeks ]
    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 [ Time Frame: Baseline and 12 weeks ]
    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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 12 Weeks ]
    Average hourly FVC AUC0-6 minus baseline FVC

  • Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks [ Time Frame: Baseline and 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 [ Time Frame: 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 [ Time Frame: Baseline and 6 Weeks ]
    Average hourly FVC AUC0-6 minus baseline FVC

  • Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1 [ Time Frame: 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 [ Time Frame: baseline and 6 Weeks (after first dose) ]
    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 [ Time Frame: Baseline and 12 Weeks ]
    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 [ 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 ]
    Puffs of rescue albuterol used during the day in week 1

  • Day Time Albuterol Use During Week 2 [ Time Frame: Week 2 ]
    Puffs of rescue albuterol used during the day in week 2

  • Day Time Albuterol Use During Week 3 [ Time Frame: Week 3 ]
    Puffs of rescue albuterol used during the day in week 3

  • Day Time Albuterol Use During Week 4 [ Time Frame: Week 4 ]
    Puffs of rescue albuterol used during the day in week 4

  • Day Time Albuterol Use During Week 5 [ Time Frame: Week 5 ]
    Puffs of rescue albuterol used during the day in week 5

  • Day Time Albuterol Use During Week 6 [ Time Frame: Week 6 ]
    Puffs of rescue albuterol used during the day in week 6

  • Day Time Albuterol Use During Week 7 [ Time Frame: Week 7 ]
    Puffs of rescue albuterol used during the day in week 7

  • Day Time Albuterol Use During Week 8 [ Time Frame: Week 8 ]
    Puffs of rescue albuterol used during the day in week 8

  • Day Time Albuterol Use During Week 9 [ Time Frame: Week 9 ]
    Puffs of rescue albuterol used during the day in week 9

  • Day Time Albuterol Use During Week 10 [ Time Frame: Week 10 ]
    Puffs of rescue albuterol used during the day in week 10

  • Day Time Albuterol Use During Week 11 [ Time Frame: Week 11 ]
    Puffs of rescue albuterol used during the day in week 11

  • Day Time Albuterol Use During Week 12 [ Time Frame: Week 12 ]
    Puffs of rescue albuterol used during the day in week 12

  • Night Time Albuterol Use During Week 1 [ Time Frame: Week 1 ]
  • Night Time Albuterol Use During Week 2 [ Time Frame: Week 2 ]
    Puffs of rescue albuterol used during the night in week 2

  • Night Time Albuterol Use During Week 3 [ Time Frame: Week 3 ]
    Puffs of rescue albuterol used during the night in week 3

  • Night Time Albuterol Use During Week 4 [ Time Frame: Week 4 ]
    Puffs of rescue albuterol used during the night in week 4

  • Night Time Albuterol Use During Week 5 [ Time Frame: Week 5 ]
    Puffs of rescue albuterol used during the night in week 5

  • Night Time Albuterol Use During Week 6 [ Time Frame: Week 6 ]
    Puffs of rescue albuterol used during the night in week 6

  • Night Time Albuterol Use During Week 7 [ Time Frame: Week 7 ]
    Puffs of rescue albuterol used during the night in week 7

  • Night Time Albuterol Use During Week 8 [ Time Frame: Week 8 ]
    Puffs of rescue albuterol used during the night in week 8

  • Night Time Albuterol Use During Week 9 [ Time Frame: Week 9 ]
    Puffs of rescue albuterol used during the night in week 9

  • Night Time Albuterol Use During Week 10 [ Time Frame: Week 10 ]
    Puffs of rescue albuterol used during the night in week 10

  • Night Time Albuterol Use During Week 11 [ Time Frame: Week 11 ]
    Puffs of rescue albuterol used during the night in week 11

  • Night Time Albuterol Use During Week 12 [ Time Frame: Week 12 ]
    Puffs of rescue albuterol used during the night in week 12

  • Morning Peak Expiratory Flow Rate (PEFR) at Week 1 [ Time Frame: Week 1 ]
  • Morning PEFR at Week 2 [ Time Frame: Week 2 ]
    Weekly means for morning PEFR

  • Morning PEFR at Week 3 [ Time Frame: Week 3 ]
    Weekly means for morning PEFR

  • Morning PEFR at Week 4 [ Time Frame: Week 4 ]
    Weekly means for morning PEFR

  • Morning PEFR at Week 5 [ Time Frame: Week 5 ]
    Weekly means for morning PEFR

  • Morning PEFR at Week 6 [ Time Frame: Week 6 ]
    Weekly means for morning PEFR

  • Morning PEFR at Week 7 [ Time Frame: Week 7 ]
    Weekly means for morning PEFR

  • Morning PEFR at Week 8 [ Time Frame: Week 8 ]
    Weekly means for morning PEFR

  • Morning PEFR at Week 9 [ Time Frame: Week 9 ]
    Weekly means for morning PEFR

  • Morning PEFR at Week 10 [ Time Frame: Week 10 ]
    Weekly means for morning PEFR

  • Morning PEFR at Week 11 [ Time Frame: Week 11 ]
    Weekly means for morning PEFR

  • Morning PEFR at Week 12 [ Time Frame: Week 12 ]
    Weekly means for morning PEFR

  • Evening PEFR at Week 1 [ Time Frame: Week 1 ]
    Weekly means for evening PEFR

  • Evening PEFR at Week 2 [ Time Frame: Week 2 ]
    Weekly means for evening PEFR

  • Evening PEFR at Week 3 [ Time Frame: Week 3 ]
    Weekly means for evening PEFR

  • Evening PEFR at Week 4 [ Time Frame: Week 4 ]
    Weekly means for evening PEFR

  • Evening PEFR at Week 5 [ Time Frame: Week 5 ]
    Weekly means for evening PEFR

  • Evening PEFR at Week 6 [ Time Frame: Week 6 ]
    Weekly means for evening PEFR

  • Evening PEFR at Week 7 [ Time Frame: Week 7 ]
    Weekly means for evening PEFR

  • Evening PEFR at Week 8 [ Time Frame: Week 8 ]
    Weekly means for evening PEFR

  • Evening PEFR at Week 9 [ Time Frame: Week 9 ]
    Weekly means for evening PEFR

  • Evening PEFR at Week 10 [ Time Frame: Week 10 ]
    Weekly means for evening PEFR

  • Evening PEFR at Week 11 [ Time Frame: Week 11 ]
    Weekly means for evening PEFR

  • Evening PEFR at Week 12 [ Time Frame: Week 12 ]
    Weekly means for evening PEFR

  • Patient Global Evaluation [ Time Frame: Week 6 ]
    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 [ Time Frame: Week 12 ]
    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 [ Time Frame: Week 6 ]
    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 [ Time Frame: Week 12 ]
    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).


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359788

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

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00359788     History of Changes
Other Study ID Numbers: 205.325
Study First Received: August 1, 2006
Results First Received: April 17, 2009
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive
Albuterol
Ipratropium
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents
Parasympatholytics

ClinicalTrials.gov processed this record on August 25, 2014