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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00274560
Collaborator
(none)
653
Enrollment
50
Locations
13.1
Patients Per Site

Study Details

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 .

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
653 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date :
May 1, 2002
Actual Primary Completion Date :
Mar 1, 2003

Outcome Measures

Primary Outcome Measures

  1. FEV1 area under the curve for the time period of 0 to 12 hours (FEV1 AUC0-12) [12 weeks]

  2. peak FEV1 [12 weeks]

Secondary Outcome Measures

  1. Trough FEV1: Trough FEV1 was the FEV1 measured prior to dosing [12 weeks]

  2. Trough and peak FVC and FVC AUC0-12 measured at the same times as FEV1 on each test day [12 weeks]

  3. Individual FEV1 and FVC measurements at each timepoint [12 weeks]

  4. Number (%) of patients with at least one exacerbation of COPD [12 weeks]

  5. time to first exacerbation [12 weeks]

  6. number of exacerbations [12 weeks]

  7. number of exacerbation days [12 weeks]

  8. Average daily occasions of rescue medication [albuterol (salbutamol)] use each week [12 weeks]

  9. All adverse events [12 weeks]

  10. Pulse rate measured in conjunction with spirometry [12 weeks]

  11. Blood pressure (seated) measured in conjunction with spirometry [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Contacts and Locations

Locations

Site City State Country Postal Code
1 UAB Medical Center Birmingham Alabama United States
2 Boehringer Ingelheim Investigational Site Jasper Alabama United States
3 Boehringer Ingelheim Investigational Site Phoenix Arizona United States
4 Southern Arizona VA Health Care System Tuscon Arizona United States
5 Boehringer Ingelheim Investigational Site Fullerton California United States
6 VA Greater Los angeles Health Care Systems Sepulveda California United States
7 Olive View UCLA Medical Center Sylmar California United States
8 Boehringer Ingelheim Investigational Site Boulder Colorado United States
9 Colorado Pulmonary Associates Denver Colorado United States
10 Boehringer Ingelheim Investigational Site Wheat Ridge Colorado United States
11 Boehringer Ingelheim Investigational Site Melbourne Florida United States
12 Boehringer Ingelheim Investigational Site Pembroke Pines Florida United States
13 University Medical Associates, LLP Augusta Georgia United States
14 Boehringer Ingelheim Investigational Site Coeur d' Alene Idaho United States
15 LSU MC-Sheveport Shreveport Louisiana United States
16 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States
17 The Oregon Clinic Portland Oregon United States
18 Temple University School of Medicine Philadelphia Pennsylvania United States
19 Attention: Thomas D. Kaelin, Jr., D.O. Charleston South Carolina United States
20 Boehringer Ingelheim Investigational Site Houston Texas United States
21 HEMO Oy Health Center Lahti Finland
22 Boehringer Ingelheim Investigational Site Mikkeli Finland
23 Boehringer Ingelheim Investigational Site Oulu Finland
24 Gen. Hosp. "Evangelismos", Athens Greece
25 Gen. Hosp. of Chest Diseases "Sotiria" Athens Greece
26 Gen. Hosp. of Chest Diseases"Sotiria" Athens Greece
27 University Hospital of Ioannina Ioannina Greece
28 General Hospital "Sismanoglio", 3rd Pneumonology Dpt Maroussi, Athens Greece
29 General Hospital "Papanicolaou", Thessaloniki Greece
30 Azienda Ospedaliera S. Martino Genova Italy
31 A.O. Pisana Pisa Italy
32 Hospital de Santa Maria Lisboa Portugal
33 Hospital Pulido Valente Lisboa Portugal
34 Hospital de São João Porto Portugal
35 Centro Hospitalar de Vila Nova de Gaia Vila Nova de Gaia Portugal
36 Lindesbergs lasarett Lindesberg Sweden
37 Boehringer Ingelheim Investigational Site Linköping Sweden
38 Vårdcentralen Brinken Motala Sweden
39 Boehringer Ingelheim Investigational Site Stockholm Sweden
40 Fysiologlaboratoriet Stockholm Sweden
41 Boehringer Ingelheim Investigational Site Uppsala Sweden
42 Boehringer Ingelheim Investigational Site Örebro Sweden
43 Gazi Universitesi Tip Fakultesi Ankara Turkey
44 Istanbul Universitesi Cerrahpasa Tip Fakültesi Istanbul Turkey
45 Yedikule Gögüs Hastaliklari Hastanesi Istanbul Turkey
46 Ege Universitesi Tip Fakultesi Izmir Turkey
47 Frenchay Healthcare NHS Trust Bristol United Kingdom
48 Boehringer Ingelheim Investigational Site Glasgow United Kingdom
49 West Middlesex University Hospital Isleworth United Kingdom
50 Medicines Evaluation Unit Manchester United Kingdom

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim Study Coordinator, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00274560
Other Study ID Numbers:
  • 205.264
First Posted:
Jan 11, 2006
Last Update Posted:
Nov 11, 2013
Last Verified:
Nov 1, 2013
Additional relevant MeSH terms:
Lung Diseases
Respiratory Aspiration
Pulmonary Disease, Chronic Obstructive
Tiotropium Bromide
Salmeterol Xinafoate

Study Results

No Results Posted as of Nov 11, 2013