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

November 30, 2023 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

327

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Trough FEV1
Time Frame: after 12 weeks of treatment
after 12 weeks of treatment
FEV1 AUC0-6 hours
Time Frame: after 12 weeks of treatment
after 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak FEV1
Time Frame: 12 weeks
12 weeks
Peak FEV1
Time Frame: after first dose and 6 week
after first dose and 6 week
FEV1 AUC0-6 hours
Time Frame: after first dose and 6 weeks
after first dose and 6 weeks
Trough FEV1
Time Frame: at 6 weeks
at 6 weeks
Peak FVC at all clinic visits
Time Frame: 12 weeks
12 weeks
AUC0-6 hours FVC at all clinic visits
Time Frame: 12 weeks
12 weeks
Trough FVC
Time Frame: at 6 and 12 weeks
at 6 and 12 weeks
Individual FEV1 measurements
Time Frame: 12 weeks
12 weeks
Individual FVC measurements
Time Frame: 12 weeks
12 weeks
Use of Albuterol (scheduled and rescue)
Time Frame: 12 weeks
12 weeks
Patient Global Evaluation
Time Frame: 12 weeks
12 weeks
Physician Global Evaluation
Time Frame: 12 weeks
12 weeks
PEFR (Peak expiratory flow rate) measured by the patient at home twice daily
Time Frame: 12 weeks
12 weeks
Occurrence of adverse events
Time Frame: 12 weeks
12 weeks
Vital Signs
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2006

Primary Completion (Actual)

October 8, 2007

Study Registration Dates

First Submitted

October 16, 2006

First Submitted That Met QC Criteria

October 16, 2006

First Posted (Estimated)

October 17, 2006

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.346
  • EudraCT 2006-000822-30

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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