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Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.
This study has been completed.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00388882
  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 IV

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for: Tiotropium Tiotropium bromide Albuterol sulfate Albuterol Levalbuterol hydrochloride Levalbuterol tartrate Ipratropium Ipratropium bromide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Randomized, Double-Blind, Parallel Group Trial Comparing 12 Weeks Treatment With Tiotropium 18 Mcg Daily With Combivent MDI 2 Actuations Qid

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Enrollment: 327
Study Start Date: October 2006
Primary Completion Date: October 2007 (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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388882

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

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 205.346, EudraCT 2006-000822-30
Study First Received: October 16, 2006
Last Updated: November 25, 2008
ClinicalTrials.gov Identifier: NCT00388882  
Health Authority: Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnología);   Great Britain: MHRA;   Lithuania: State Medicines Control Agency, LT-01132 Vilnius;   Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26;   United States: Food and Drug Administration

Study placed in the following topic categories:
Lung Diseases, Obstructive
Ipratropium
Respiratory Tract Diseases
Bromides
Lung Diseases
Albuterol
Chronic Disease
Tiotropium
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Parasympatholytics
Respiratory System Agents
Disease Attributes
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cholinergic Agents
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009