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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
tiotropium
ipratropium bromide / albuterol
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 205.346.107 Boehringer Ingelheim Investigational Site
  • 205.346.104 Boehringer Ingelheim Investigational Site
  • 205.346.108 Boehringer Ingelheim Investigational Site
  • 205.346.101 Boehringer Ingelheim Investigational Site
  • 205.346.106 Boehringer Ingelheim Investigational Site
  • 205.346.102 Boehringer Ingelheim Investigational Site
  • 205.346.109 Boehringer Ingelheim Investigational Site
  • 205.346.110 Boehringer Ingelheim Investigational Site
  • 205.346.105 Boehringer Ingelheim Investigational Site
  • 205.346.103 Boehringer Ingelheim Investigational Site
  • 205.346.510
  • 205.346.508
  • 205.346.502
  • 205.346.503
  • 205.346.505
  • 205.346.509
  • 205.346.511
  • 205.346.504 Instituto de Patologías Respiratorias
  • 205.346.401 Boehringer Ingelheim Investigational Site
  • 205.346.404 Boehringer Ingelheim Investigational Site
  • 205.346.405 Boehringer Ingelheim Investigational Site
  • 205.346.411 Boehringer Ingelheim Investigational Site
  • 205.346.409 Boehringer Ingelheim Investigational Site
  • 205.346.408 Boehringer Ingelheim Investigational Site
  • 205.346.402 Boehringer Ingelheim Investigational Site
  • 205.346.406 Boehringer Ingelheim Investigational Site
  • 205.346.407 Boehringer Ingelheim Investigational Site
  • 205.346.302 Boehringer Ingelheim Investigational Site
  • 205.346.305 Boehringer Ingelheim Investigational Site
  • 205.346.301 Boehringer Ingelheim Investigational Site
  • 205.346.303 Boehringer Ingelheim Investigational Site
  • 205.346.304 Boehringer Ingelheim Investigational Site
  • 205.346.306 Boehringer Ingelheim Investigational Site
  • 205.346.204 Boehringer Ingelheim Investigational Site
  • 205.346.203 Boehringer Ingelheim Investigational Site
  • 205.346.201 Boehringer Ingelheim Investigational Site
  • 205.346.207 Boehringer Ingelheim Investigational Site
  • 205.346.209 Boehringer Ingelheim Investigational Site
  • 205.346.206 Boehringer Ingelheim Investigational Site
  • 205.346.205 Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

Trough FEV1
FEV1 AUC0-6 hours

Secondary Outcome Measures

Peak FEV1
Peak FEV1
FEV1 AUC0-6 hours
Trough FEV1
Peak FVC at all clinic visits
AUC0-6 hours FVC at all clinic visits
Trough FVC
Individual FEV1 measurements
Individual FVC measurements
Use of Albuterol (scheduled and rescue)
Patient Global Evaluation
Physician Global Evaluation
PEFR (Peak expiratory flow rate) measured by the patient at home twice daily
Occurrence of adverse events
Vital Signs

Full Information

First Posted
October 16, 2006
Last Updated
December 27, 2017
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00388882
Brief Title
Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Enrollment
327 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tiotropium
Intervention Type
Drug
Intervention Name(s)
ipratropium bromide / albuterol
Primary Outcome Measure Information:
Title
Trough FEV1
Time Frame
after 12 weeks of treatment
Title
FEV1 AUC0-6 hours
Time Frame
after 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Peak FEV1
Time Frame
12 weeks
Title
Peak FEV1
Time Frame
after first dose and 6 week
Title
FEV1 AUC0-6 hours
Time Frame
after first dose and 6 weeks
Title
Trough FEV1
Time Frame
at 6 weeks
Title
Peak FVC at all clinic visits
Time Frame
12 weeks
Title
AUC0-6 hours FVC at all clinic visits
Time Frame
12 weeks
Title
Trough FVC
Time Frame
at 6 and 12 weeks
Title
Individual FEV1 measurements
Time Frame
12 weeks
Title
Individual FVC measurements
Time Frame
12 weeks
Title
Use of Albuterol (scheduled and rescue)
Time Frame
12 weeks
Title
Patient Global Evaluation
Time Frame
12 weeks
Title
Physician Global Evaluation
Time Frame
12 weeks
Title
PEFR (Peak expiratory flow rate) measured by the patient at home twice daily
Time Frame
12 weeks
Title
Occurrence of adverse events
Time Frame
12 weeks
Title
Vital Signs
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
205.346.107 Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
205.346.104 Boehringer Ingelheim Investigational Site
City
Lakewood
State/Province
California
Country
United States
Facility Name
205.346.108 Boehringer Ingelheim Investigational Site
City
Sepulveda
State/Province
California
Country
United States
Facility Name
205.346.101 Boehringer Ingelheim Investigational Site
City
Torrance
State/Province
California
Country
United States
Facility Name
205.346.106 Boehringer Ingelheim Investigational Site
City
Wheat Ridge
State/Province
Colorado
Country
United States
Facility Name
205.346.102 Boehringer Ingelheim Investigational Site
City
Coeur d'Alene
State/Province
Idaho
Country
United States
Facility Name
205.346.109 Boehringer Ingelheim Investigational Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
205.346.110 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
205.346.105 Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
205.346.103 Boehringer Ingelheim Investigational Site
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
205.346.510
City
Bs As
Country
Argentina
Facility Name
205.346.508
City
Buenos Airess
Country
Argentina
Facility Name
205.346.502
City
Buenos Aires
Country
Argentina
Facility Name
205.346.503
City
Buenos Aires
Country
Argentina
Facility Name
205.346.505
City
Mendoza
Country
Argentina
Facility Name
205.346.509
City
Rosario, Santa Fe
Country
Argentina
Facility Name
205.346.511
City
Rosario, Santa Fé
Country
Argentina
Facility Name
205.346.504 Instituto de Patologías Respiratorias
City
San Miguel de Tucumán
Country
Argentina
Facility Name
205.346.401 Boehringer Ingelheim Investigational Site
City
Alytus
Country
Lithuania
Facility Name
205.346.404 Boehringer Ingelheim Investigational Site
City
Kaunas
Country
Lithuania
Facility Name
205.346.405 Boehringer Ingelheim Investigational Site
City
Kaunas
Country
Lithuania
Facility Name
205.346.411 Boehringer Ingelheim Investigational Site
City
Klaipeda
Country
Lithuania
Facility Name
205.346.409 Boehringer Ingelheim Investigational Site
City
Siauliai
Country
Lithuania
Facility Name
205.346.408 Boehringer Ingelheim Investigational Site
City
Utena
Country
Lithuania
Facility Name
205.346.402 Boehringer Ingelheim Investigational Site
City
Vilnius
Country
Lithuania
Facility Name
205.346.406 Boehringer Ingelheim Investigational Site
City
Vilnius
Country
Lithuania
Facility Name
205.346.407 Boehringer Ingelheim Investigational Site
City
Vilnius
Country
Lithuania
Facility Name
205.346.302 Boehringer Ingelheim Investigational Site
City
Bratislava
Country
Slovakia
Facility Name
205.346.305 Boehringer Ingelheim Investigational Site
City
Bratislava
Country
Slovakia
Facility Name
205.346.301 Boehringer Ingelheim Investigational Site
City
Kosice
Country
Slovakia
Facility Name
205.346.303 Boehringer Ingelheim Investigational Site
City
Levica
Country
Slovakia
Facility Name
205.346.304 Boehringer Ingelheim Investigational Site
City
Lucenec
Country
Slovakia
Facility Name
205.346.306 Boehringer Ingelheim Investigational Site
City
Sturovo
Country
Slovakia
Facility Name
205.346.204 Boehringer Ingelheim Investigational Site
City
Aylesbury
Country
United Kingdom
Facility Name
205.346.203 Boehringer Ingelheim Investigational Site
City
Greenisland
Country
United Kingdom
Facility Name
205.346.201 Boehringer Ingelheim Investigational Site
City
Nottingham
Country
United Kingdom
Facility Name
205.346.207 Boehringer Ingelheim Investigational Site
City
Soham
Country
United Kingdom
Facility Name
205.346.209 Boehringer Ingelheim Investigational Site
City
Swansea
Country
United Kingdom
Facility Name
205.346.206 Boehringer Ingelheim Investigational Site
City
Westbury On Trym
Country
United Kingdom
Facility Name
205.346.205 Boehringer Ingelheim Investigational Site
City
Windsor
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.346_U08-3233.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.346_literature.pdf
Description
Related Info
URL
https://www.ncbi.nlm.nih.gov/pubmed/19737620
Description
Related Info

Learn more about this trial

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

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