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A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol.

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tiotropium
Salmeterol
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

Sites / Locations

  • UAB Medical Center
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Southern Arizona VA Health Care System
  • Boehringer Ingelheim Investigational Site
  • VA Greater Los angeles Health Care Systems
  • Olive View UCLA Medical Center
  • Boehringer Ingelheim Investigational Site
  • Colorado Pulmonary Associates
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • University Medical Associates, LLP
  • Boehringer Ingelheim Investigational Site
  • LSU MC-Sheveport
  • University of Oklahoma Health Sciences Center
  • The Oregon Clinic
  • Temple University School of Medicine
  • Attention: Thomas D. Kaelin, Jr., D.O.
  • Boehringer Ingelheim Investigational Site
  • HEMO Oy Health Center
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Gen. Hosp. "Evangelismos",
  • Gen. Hosp. of Chest Diseases "Sotiria"
  • Gen. Hosp. of Chest Diseases"Sotiria"
  • University Hospital of Ioannina
  • General Hospital "Sismanoglio", 3rd Pneumonology Dpt
  • General Hospital "Papanicolaou",
  • Azienda Ospedaliera S. Martino
  • A.O. Pisana
  • Hospital de Santa Maria
  • Hospital Pulido Valente
  • Hospital de São João
  • Centro Hospitalar de Vila Nova de Gaia
  • Lindesbergs lasarett
  • Boehringer Ingelheim Investigational Site
  • Vårdcentralen Brinken
  • Boehringer Ingelheim Investigational Site
  • Fysiologlaboratoriet
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Gazi Universitesi Tip Fakultesi
  • Istanbul Universitesi Cerrahpasa Tip Fakültesi
  • Yedikule Gögüs Hastaliklari Hastanesi
  • Ege Universitesi Tip Fakultesi
  • Frenchay Healthcare NHS Trust
  • Boehringer Ingelheim Investigational Site
  • West Middlesex University Hospital
  • Medicines Evaluation Unit

Outcomes

Primary Outcome Measures

FEV1 area under the curve for the time period of 0 to 12 hours (FEV1 AUC0-12)
peak FEV1

Secondary Outcome Measures

Trough FEV1: Trough FEV1 was the FEV1 measured prior to dosing
Trough and peak FVC and FVC AUC0-12 measured at the same times as FEV1 on each test day
Individual FEV1 and FVC measurements at each timepoint
Number (%) of patients with at least one exacerbation of COPD
time to first exacerbation
number of exacerbations
number of exacerbation days
Average daily occasions of rescue medication [albuterol (salbutamol)] use each week
All adverse events
Pulse rate measured in conjunction with spirometry
Blood pressure (seated) measured in conjunction with spirometry

Full Information

First Posted
January 9, 2006
Last Updated
November 8, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00274560
Brief Title
A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol.
Official Title
A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol in a 12 Week, Randomized, Double-Blind, Double-Dummy Parallel Group Study in Patients With Chronic Obstructive Pulmonary Disease (COPD).
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
March 2003 (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 the study was to evaluate the degree of improvement in lung function in patients with chronic obstructive pulmonary disease (COPD) after treatment with tiotropium inhalation capsules compared to salmeterol inhalation aerosol .

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
653 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tiotropium
Intervention Type
Drug
Intervention Name(s)
Salmeterol
Primary Outcome Measure Information:
Title
FEV1 area under the curve for the time period of 0 to 12 hours (FEV1 AUC0-12)
Time Frame
12 weeks
Title
peak FEV1
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Trough FEV1: Trough FEV1 was the FEV1 measured prior to dosing
Time Frame
12 weeks
Title
Trough and peak FVC and FVC AUC0-12 measured at the same times as FEV1 on each test day
Time Frame
12 weeks
Title
Individual FEV1 and FVC measurements at each timepoint
Time Frame
12 weeks
Title
Number (%) of patients with at least one exacerbation of COPD
Time Frame
12 weeks
Title
time to first exacerbation
Time Frame
12 weeks
Title
number of exacerbations
Time Frame
12 weeks
Title
number of exacerbation days
Time Frame
12 weeks
Title
Average daily occasions of rescue medication [albuterol (salbutamol)] use each week
Time Frame
12 weeks
Title
All adverse events
Time Frame
12 weeks
Title
Pulse rate measured in conjunction with spirometry
Time Frame
12 weeks
Title
Blood pressure (seated) measured in conjunction with spirometry
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
UAB Medical Center
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Jasper
State/Province
Alabama
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Southern Arizona VA Health Care System
City
Tuscon
State/Province
Arizona
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Fullerton
State/Province
California
Country
United States
Facility Name
VA Greater Los angeles Health Care Systems
City
Sepulveda
State/Province
California
Country
United States
Facility Name
Olive View UCLA Medical Center
City
Sylmar
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Boulder
State/Province
Colorado
Country
United States
Facility Name
Colorado Pulmonary Associates
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Wheat Ridge
State/Province
Colorado
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Melbourne
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
University Medical Associates, LLP
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Coeur d' Alene
State/Province
Idaho
Country
United States
Facility Name
LSU MC-Sheveport
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
The Oregon Clinic
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Temple University School of Medicine
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Attention: Thomas D. Kaelin, Jr., D.O.
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
HEMO Oy Health Center
City
Lahti
Country
Finland
Facility Name
Boehringer Ingelheim Investigational Site
City
Mikkeli
Country
Finland
Facility Name
Boehringer Ingelheim Investigational Site
City
Oulu
Country
Finland
Facility Name
Gen. Hosp. "Evangelismos",
City
Athens
Country
Greece
Facility Name
Gen. Hosp. of Chest Diseases "Sotiria"
City
Athens
Country
Greece
Facility Name
Gen. Hosp. of Chest Diseases"Sotiria"
City
Athens
Country
Greece
Facility Name
University Hospital of Ioannina
City
Ioannina
Country
Greece
Facility Name
General Hospital "Sismanoglio", 3rd Pneumonology Dpt
City
Maroussi, Athens
Country
Greece
Facility Name
General Hospital "Papanicolaou",
City
Thessaloniki
Country
Greece
Facility Name
Azienda Ospedaliera S. Martino
City
Genova
Country
Italy
Facility Name
A.O. Pisana
City
Pisa
Country
Italy
Facility Name
Hospital de Santa Maria
City
Lisboa
Country
Portugal
Facility Name
Hospital Pulido Valente
City
Lisboa
Country
Portugal
Facility Name
Hospital de São João
City
Porto
Country
Portugal
Facility Name
Centro Hospitalar de Vila Nova de Gaia
City
Vila Nova de Gaia
Country
Portugal
Facility Name
Lindesbergs lasarett
City
Lindesberg
Country
Sweden
Facility Name
Boehringer Ingelheim Investigational Site
City
Linköping
Country
Sweden
Facility Name
Vårdcentralen Brinken
City
Motala
Country
Sweden
Facility Name
Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
Fysiologlaboratoriet
City
Stockholm
Country
Sweden
Facility Name
Boehringer Ingelheim Investigational Site
City
Uppsala
Country
Sweden
Facility Name
Boehringer Ingelheim Investigational Site
City
Örebro
Country
Sweden
Facility Name
Gazi Universitesi Tip Fakultesi
City
Ankara
Country
Turkey
Facility Name
Istanbul Universitesi Cerrahpasa Tip Fakültesi
City
Istanbul
Country
Turkey
Facility Name
Yedikule Gögüs Hastaliklari Hastanesi
City
Istanbul
Country
Turkey
Facility Name
Ege Universitesi Tip Fakultesi
City
Izmir
Country
Turkey
Facility Name
Frenchay Healthcare NHS Trust
City
Bristol
Country
United Kingdom
Facility Name
Boehringer Ingelheim Investigational Site
City
Glasgow
Country
United Kingdom
Facility Name
West Middlesex University Hospital
City
Isleworth
Country
United Kingdom
Facility Name
Medicines Evaluation Unit
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.264.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.264_literature.pdf
Description
Related Info

Learn more about this trial

A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol.

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