Full Text View
Tabular View
No Study Results Posted
Related Studies
Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.
This study has been completed.
First Received: October 16, 2006   Last Updated: September 28, 2009   History of Changes
Sponsor: 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

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

Resource links provided by NLM:


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

  Hide Study Locations
Locations
United States, Arizona
205.346.107 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
United States, California
205.346.101 Boehringer Ingelheim Investigational Site
Torrance, California, United States
205.346.104 Boehringer Ingelheim Investigational Site
Lakewood, California, United States
205.346.108 Boehringer Ingelheim Investigational Site
Sepulveda, California, United States
United States, Colorado
205.346.106 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
United States, Idaho
205.346.102 Boehringer Ingelheim Investigational Site
Couer d'Alene, Idaho, United States
United States, Louisiana
205.346.109 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana, United States
United States, Pennsylvania
205.346.110 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
United States, South Carolina
205.346.103 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
205.346.105 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
Argentina
205.346.502
Buenos Aires, Argentina
205.346.503
Buenos Aires, Argentina
205.346.504 Instituto de Patologías Respiratorias
San Miguel de Tucumán, Argentina
205.346.505
Mendoza, Argentina
205.346.508
Buenos Airess, Argentina
205.346.509
Rosario, Santa Fe, Argentina
205.346.510
Bs As, Argentina
205.346.511
Rosario, Santa Fé, Argentina
Lithuania
205.346.401 Boehringer Ingelheim Investigational Site
Alytus, Lithuania
205.346.402 Boehringer Ingelheim Investigational Site
Vilnius, Lithuania
205.346.404 Boehringer Ingelheim Investigational Site
Kaunas, Lithuania
205.346.405 Boehringer Ingelheim Investigational Site
Kaunas, Lithuania
205.346.406 Boehringer Ingelheim Investigational Site
Vilnius, Lithuania
205.346.407 Boehringer Ingelheim Investigational Site
Vilnius, Lithuania
205.346.408 Boehringer Ingelheim Investigational Site
Utena, Lithuania
205.346.409 Boehringer Ingelheim Investigational Site
Siauliai, Lithuania
205.346.411 Boehringer Ingelheim Investigational Site
Klaipeda, Lithuania
Slovakia
205.346.301 Boehringer Ingelheim Investigational Site
Kosice, Slovakia
205.346.302 Boehringer Ingelheim Investigational Site
Bratislava, Slovakia
205.346.303 Boehringer Ingelheim Investigational Site
Levica, Slovakia
205.346.304 Boehringer Ingelheim Investigational Site
Lucenec, Slovakia
205.346.305 Boehringer Ingelheim Investigational Site
Bratislava, Slovakia
205.346.306 Boehringer Ingelheim Investigational Site
Sturovo, Slovakia
United Kingdom
205.346.201 Boehringer Ingelheim Investigational Site
Nottingham, United Kingdom
205.346.203 Boehringer Ingelheim Investigational Site
Greenisland, United Kingdom
205.346.209 Boehringer Ingelheim Investigational Site
Swansea, United Kingdom
205.346.205 Boehringer Ingelheim Investigational Site
Windsor, United Kingdom
205.346.206 Boehringer Ingelheim Investigational Site
Westbury on Trym, United Kingdom
205.346.207 Boehringer Ingelheim Investigational Site
Soham, United Kingdom
205.346.204 Boehringer Ingelheim Investigational Site
Aylesbury, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
No publications provided

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: September 28, 2009
ClinicalTrials.gov Identifier: NCT00388882     History of Changes
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

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 November 27, 2009