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Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With COPD

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tiotropium
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: History of COPD, FEV1 less than or equal to 65%, FEV1/FVC less than or equal 70% Smoking history greater than or equal to 10 pack years Not history of clinical diagnosis of asthma and/or atopy A history of thoracotomy with pulmonary resection Patients requiring the use of supplemental oxygen therapy for >12 hours per day Chronic use of systemic corticosteroids in an unstable daily dose Patients with a recent history of myocardial infarction A known hypersensitivity to anticholinergic drugs

Sites / Locations

  • Attn: William C. Bailey, M.D.
  • Boehringer Ingelheim Investigational Site
  • Olive View UCLA Medical Center
  • Rocky Mountain Center for Clinical Research
  • Respiratory Diseases (111A)
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • LSU Health Sciences Center
  • Pulmonary and Critical Care Services, PC
  • The Oregon Clinic
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

Trough FEV1 after 12 weeks of treatment

Secondary Outcome Measures

Trough FEV1 at Visit 3
Trough FVC at Visits 3 and 4
FEV1 and FVC 90 min post study drug inhalation at all visits
Use of rescue medication
Patient's Global Evaluation
Physician's Global Evaluation
Health Related Quality of Life assessed by the EQ5D at Visit 2 and 4
Adverse events
Vital signs
Physical Exam
12-lead ECG
24-hour holter ECG monitoring

Full Information

First Posted
October 14, 2005
Last Updated
October 31, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00239460
Brief Title
Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With COPD
Official Title
Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With Chronic Obstructive Pulmonary Disease (a 12-week, Parallel Group, Randomized, Placebo-cotrolled, Double-blind Study).
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
March 2004 (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 effect of inhaled tiotropium bromide on trough FEV1 and to assess the cardiac effects through 12-lead and Holter ECG monitoring in patients with COPD.

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 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
196 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tiotropium
Primary Outcome Measure Information:
Title
Trough FEV1 after 12 weeks of treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Trough FEV1 at Visit 3
Time Frame
week 8
Title
Trough FVC at Visits 3 and 4
Time Frame
week 8 and week 12
Title
FEV1 and FVC 90 min post study drug inhalation at all visits
Time Frame
90 minutes post-medication
Title
Use of rescue medication
Time Frame
12 weeks
Title
Patient's Global Evaluation
Time Frame
week 8 and week 12
Title
Physician's Global Evaluation
Time Frame
week 8 and week 12
Title
Health Related Quality of Life assessed by the EQ5D at Visit 2 and 4
Time Frame
week 8 and week 12
Title
Adverse events
Time Frame
12 weeks
Title
Vital signs
Time Frame
week 8 and week 12
Title
Physical Exam
Time Frame
week 12
Title
12-lead ECG
Time Frame
week 8 and week 12
Title
24-hour holter ECG monitoring
Time Frame
week 8 and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of COPD, FEV1 less than or equal to 65%, FEV1/FVC less than or equal 70% Smoking history greater than or equal to 10 pack years Not history of clinical diagnosis of asthma and/or atopy A history of thoracotomy with pulmonary resection Patients requiring the use of supplemental oxygen therapy for >12 hours per day Chronic use of systemic corticosteroids in an unstable daily dose Patients with a recent history of myocardial infarction A known hypersensitivity to anticholinergic drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Attn: William C. Bailey, M.D.
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Olive View UCLA Medical Center
City
Sylmar
State/Province
California
Country
United States
Facility Name
Rocky Mountain Center for Clinical Research
City
Wheat Ridge
State/Province
Colorado
Country
United States
Facility Name
Respiratory Diseases (111A)
City
Bay Pines
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Coeur d' Alene
State/Province
Idaho
Country
United States
Facility Name
LSU Health Sciences Center
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Pulmonary and Critical Care Services, PC
City
Albany
State/Province
New York
Country
United States
Facility Name
The Oregon Clinic
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25496316
Citation
Hohlfeld JM, Furtwaengler A, Konen-Bergmann M, Wallenstein G, Walter B, Bateman ED. Cardiac safety of tiotropium in patients with COPD: a combined analysis of Holter-ECG data from four randomised clinical trials. Int J Clin Pract. 2015 Jan;69(1):72-80. doi: 10.1111/ijcp.12596. Epub 2014 Dec 11.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.284_U04-3374.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.284_literature.pdf
Description
Related Info

Learn more about this trial

Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With COPD

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