Full Text View
Tabular View
No Study Results Posted
Related Studies
A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.
This study has been completed.
Study NCT00359788   Information provided by Boehringer Ingelheim Pharmaceuticals
First Received: August 1, 2006   Last Updated: November 7, 2008   History of Changes

August 1, 2006
November 7, 2008
July 2006
April 2008   (final data collection date for primary outcome measure)
Trough and AUC0-6 FEV1 after 12 weeks. [ Time Frame: 12 weeks ]
Trough and AUC0-6 FEV1 after 12 weeks.
Complete list of historical versions of study NCT00359788 on ClinicalTrials.gov Archive Site
Peak FEV1, FVC (trough, peak, AUC0-6), FEV1 and FVC at each timepoint, trough FEV1 at 6 weeks, albuterol use, Patient and Physician Global Evaluations, daily PEFR [ Time Frame: 6 weeks and 12 weeks ]
Peak FEV1, FVC (trough, peak, AUC0-6), FEV1 and FVC at each timepoint, trough FEV1 at 6 weeks, albuterol use, Patient and Physician Global Evaluations, daily PEFR
 
A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.
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

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 COPD patients currently prescribed Combivent® MDI.

 
Phase IV
Interventional
Treatment, Parallel Assignment, Safety/Efficacy Study
Pulmonary Disease, Chronic Obstructive
  • Drug: tiotropium
  • Drug: ipratropium bromide / albuterol
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
349
 
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

Inclusion Criteria: Diagnosis of COPD Age: greater than or equal to 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:

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 fr om 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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00359788
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
205.325
Boehringer Ingelheim Pharmaceuticals
 
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP