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

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. Identifier: NCT00388882
Recruitment Status : Completed
First Posted : October 17, 2006
Last Update Posted : December 28, 2017
Information provided by:
Boehringer Ingelheim

October 16, 2006
October 17, 2006
December 28, 2017
October 2006
October 2007   (Final data collection date for primary outcome measure)
  • Trough FEV1 [ Time Frame: after 12 weeks of treatment ]
  • FEV1 AUC0-6 hours [ Time Frame: after 12 weeks of treatment ]
Primary endpoints: Trough and AUC0-6 FEV1 after 12 weeks.
Complete list of historical versions of study NCT00388882 on Archive Site
  • 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 ]
Secondary endpoints: 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
Not Provided
Not Provided
Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.
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
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.
Not Provided
Phase 4
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: tiotropium
  • Drug: ipratropium bromide / albuterol
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
October 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Argentina,   Lithuania,   Slovakia,   United Kingdom,   United States
EudraCT 2006-000822-30
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
December 2017

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