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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00388882
First received: October 16, 2006
Last updated: October 31, 2013
Last verified: October 2013

October 16, 2006
October 31, 2013
October 2006
October 2007   (final data collection date for primary outcome measure)
  • Trough FEV1 [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
  • FEV1 AUC0-6 hours [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
Primary endpoints: Trough and AUC0-6 FEV1 after 12 weeks.
Complete list of historical versions of study NCT00388882 on ClinicalTrials.gov Archive Site
  • Peak FEV1 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Peak FEV1 [ Time Frame: after first dose and 6 week ] [ Designated as safety issue: No ]
  • FEV1 AUC0-6 hours [ Time Frame: after first dose and 6 weeks ] [ Designated as safety issue: No ]
  • Trough FEV1 [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
  • Peak FVC at all clinic visits [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • AUC0-6 hours FVC at all clinic visits [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Trough FVC [ Time Frame: at 6 and 12 weeks ] [ Designated as safety issue: No ]
  • Individual FEV1 measurements [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Individual FVC measurements [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Use of Albuterol (scheduled and rescue) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Patient Global Evaluation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Physician Global Evaluation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • PEFR (Peak expiratory flow rate) measured by the patient at home twice daily [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Vital Signs [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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
Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
327
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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Lithuania,   Slovakia,   United Kingdom
 
NCT00388882
205.346, EudraCT 2006-000822-30
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
October 2013

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