We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00388882
First Posted: October 17, 2006
Last Update Posted: November 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
  Purpose
The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotro pium HandiHaler® 18 mcg daily compared to Combivent® MDI CFC Inhalation Aerosol 2 actuations qid in COPD patients currently prescribed Combivent® MDI.

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive Drug: tiotropium Drug: ipratropium bromide / albuterol Phase 4

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Double-dummy, Parallel Group Trial Comparing 12 Weeks Treatment With Tiotropium Inhalation Capsules 18 Mcg Via the HandiHaler® Once Daily to Combivent® Inhalation Aerosol CFC MDI 2 Actuations q.i.d. in COPD Patients Currently Prescribed Combivent® Inhalation Aerosol CFC MDI

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Trough FEV1 [ Time Frame: after 12 weeks of treatment ]
  • FEV1 AUC0-6 hours [ Time Frame: after 12 weeks of treatment ]

Secondary Outcome Measures:
  • Peak FEV1 [ Time Frame: 12 weeks ]
  • Peak FEV1 [ Time Frame: after first dose and 6 week ]
  • FEV1 AUC0-6 hours [ Time Frame: after first dose and 6 weeks ]
  • Trough FEV1 [ Time Frame: at 6 weeks ]
  • Peak FVC at all clinic visits [ Time Frame: 12 weeks ]
  • AUC0-6 hours FVC at all clinic visits [ Time Frame: 12 weeks ]
  • Trough FVC [ Time Frame: at 6 and 12 weeks ]
  • Individual FEV1 measurements [ Time Frame: 12 weeks ]
  • Individual FVC measurements [ Time Frame: 12 weeks ]
  • Use of Albuterol (scheduled and rescue) [ Time Frame: 12 weeks ]
  • Patient Global Evaluation [ Time Frame: 12 weeks ]
  • Physician Global Evaluation [ Time Frame: 12 weeks ]
  • PEFR (Peak expiratory flow rate) measured by the patient at home twice daily [ Time Frame: 12 weeks ]
  • Occurrence of adverse events [ Time Frame: 12 weeks ]
  • Vital Signs [ Time Frame: 12 weeks ]

Enrollment: 327
Study Start Date: October 2006
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of COPD
  • Age: >= 40 years
  • Current or ex-smoker with a >= 10 pack-year smoking history
  • Use of Combivent® MDI for >= 1 month prior to Visit 1 Spirometric criteria (determined at study visits):
  • Post-bronchodilator FEV1 <= 70% (Visit 1)
  • Pre-bronchodilator FEV1 <= 65% of predicted and FEV1/FVC <= 70% (Visit 2)

Exclusion Criteria:

  • Clinical history of asthma
  • History of thoracotomy with pulmonary resection
  • History of CF, alpha 1 antitrypsin deficiency or interstitial lung disease
  • Daytime use of oxygen therapy for > 1 hour per day or if unable to abstain from using oxygen during PFTs
  • Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1
  • Recent history 6 months or less of MI
  • Unstable or life-threatening cardiac arrhythmias
  • Hospitalization for CHF 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388882


  Show 40 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00388882     History of Changes
Other Study ID Numbers: 205.346
EudraCT 2006-000822-30
First Submitted: October 16, 2006
First Posted: October 17, 2006
Last Update Posted: November 1, 2013
Last Verified: October 2013

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