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

Phase 3

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00274560
• Lead Sponsor: Boehringer Ingelheim

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05-01
• Primary Completion: 2003-03-27
• Study First Submitted: 2006-01-09
• Study First Submitted QC: 2006-01-09
• Study First Posted: 2006-01-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 653

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (35)

Temple University School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

University Hospital of Ioannina; 🇬🇷 Ioannina, Greece

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

The Oregon Clinic; 🇺🇸 Portland, Oregon, United States

UAB Medical Center; 🇺🇸 Birmingham, Alabama, United States

Colorado Pulmonary Associates; 🇺🇸 Denver, Colorado, United States

Gen. Hosp. of Chest Diseases"Sotiria"; 🇬🇷 Athens, Greece

Southern Arizona VA Health Care System; 🇺🇸 Tucson, Arizona, United States

LSU MC-Sheveport; 🇺🇸 Shreveport, Louisiana, United States

Gen. Hosp. of Chest Diseases "Sotiria"; 🇬🇷 Athens, Greece

Hospital Pulido Valente; 🇵🇹 Lisboa, Portugal

Attention: Thomas D. Kaelin, Jr., D.O.; 🇺🇸 Charleston, South Carolina, United States

VA Greater Los angeles Health Care Systems; 🇺🇸 Sepulveda, California, United States

University Medical Associates, LLP; 🇺🇸 Augusta, Georgia, United States

Olive View UCLA Medical Center; 🇺🇸 Sylmar, California, United States

Boehringer Ingelheim Investigational Site; 🇬🇧 Glasgow, United Kingdom

Gen. Hosp. "Evangelismos",; 🇬🇷 Athens, Greece

General Hospital "Sismanoglio", 3rd Pneumonology Dpt; 🇬🇷 Maroussi, Athens, Greece

Azienda Ospedaliera S. Martino; 🇮🇹 Genova, Italy

HEMO Oy Health Center; 🇫🇮 Lahti, Finland

General Hospital "Papanicolaou",; 🇬🇷 Thessaloniki, Greece

Hospital de Santa Maria; 🇵🇹 Lisboa, Portugal

A.O. Pisana; 🇮🇹 Pisa, Italy

Lindesbergs lasarett; 🇸🇪 Lindesberg, Sweden

Vårdcentralen Brinken; 🇸🇪 Motala, Sweden

Centro Hospitalar de Vila Nova de Gaia; 🇵🇹 Vila Nova de Gaia, Portugal

Istanbul Universitesi Cerrahpasa Tip Fakültesi; 🇹🇷 Istanbul, Turkey

Hospital de São João; 🇵🇹 Porto, Portugal

Fysiologlaboratoriet; 🇸🇪 Stockholm, Sweden

Yedikule Gögüs Hastaliklari Hastanesi; 🇹🇷 Istanbul, Turkey

Gazi Universitesi Tip Fakultesi; 🇹🇷 Ankara, Turkey

Ege Universitesi Tip Fakultesi; 🇹🇷 Izmir, Turkey

West Middlesex University Hospital; 🇬🇧 Isleworth, United Kingdom

Medicines Evaluation Unit; 🇬🇧 Manchester, United Kingdom

Frenchay Healthcare NHS Trust; 🇬🇧 Bristol, United Kingdom