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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Disease, Chronic Obstructive

Intervention: Tiotropium (Drug); Salmeterol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim

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 .

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

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

peak FEV1

Secondary outcome:

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

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Locations and Contacts

HEMO Oy Health Center, Lahti, Finland

Boehringer Ingelheim Investigational Site, Mikkeli, Finland

Boehringer Ingelheim Investigational Site, Oulu, Finland

Gen. Hosp. "Evangelismos",, Athens, Greece

Gen. Hosp. of Chest Diseases "Sotiria", Athens, Greece

Gen. Hosp. of Chest Diseases"Sotiria", Athens, Greece

University Hospital of Ioannina, Ioannina, Greece

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

General Hospital "Papanicolaou",, Thessaloniki, Greece

Azienda Ospedaliera S. Martino, Genova, Italy

A.O. Pisana, Pisa, Italy

Hospital de Santa Maria, Lisboa, Portugal

Hospital Pulido Valente, Lisboa, Portugal

Hospital de São João, Porto, Portugal

Centro Hospitalar de Vila Nova de Gaia, Vila Nova de Gaia, Portugal

Lindesbergs lasarett, Lindesberg, Sweden

Boehringer Ingelheim Investigational Site, Linköping, Sweden

Vårdcentralen Brinken, Motala, Sweden

Boehringer Ingelheim Investigational Site, Stockholm, Sweden

Fysiologlaboratoriet, Stockholm, Sweden

Boehringer Ingelheim Investigational Site, Uppsala, Sweden

Boehringer Ingelheim Investigational Site, Örebro, Sweden

Gazi Universitesi Tip Fakultesi, Ankara, Turkey

Istanbul Universitesi Cerrahpasa Tip Fakültesi, Istanbul, Turkey

Yedikule Gögüs Hastaliklari Hastanesi, Istanbul, Turkey

Ege Universitesi Tip Fakultesi, Izmir, Turkey

Frenchay Healthcare NHS Trust, Bristol, United Kingdom

Boehringer Ingelheim Investigational Site, Glasgow, United Kingdom

West Middlesex University Hospital, Isleworth, United Kingdom

Medicines Evaluation Unit, Manchester, United Kingdom

UAB Medical Center, Birmingham, Alabama, United States

Boehringer Ingelheim Investigational Site, Jasper, Alabama, United States

Boehringer Ingelheim Investigational Site, Phoenix, Arizona, United States

Southern Arizona VA Health Care System, Tuscon, Arizona, United States

Boehringer Ingelheim Investigational Site, Fullerton, California, United States

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

Olive View UCLA Medical Center, Sylmar, California, United States

Boehringer Ingelheim Investigational Site, Boulder, Colorado, United States

Colorado Pulmonary Associates, Denver, Colorado, United States

Boehringer Ingelheim Investigational Site, Wheat Ridge, Colorado, United States

Boehringer Ingelheim Investigational Site, Melbourne, Florida, United States

Boehringer Ingelheim Investigational Site, Pembroke Pines, Florida, United States

University Medical Associates, LLP, Augusta, Georgia, United States

Boehringer Ingelheim Investigational Site, Coeur d' Alene, Idaho, United States

LSU MC-Sheveport, Shreveport, Louisiana, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

The Oregon Clinic, Portland, Oregon, United States

Temple University School of Medicine, Philadelphia, Pennsylvania, United States

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

Boehringer Ingelheim Investigational Site, Houston, Texas, United States

Additional Information

Starting date: May 2002
Last updated: November 8, 2013

Page last updated: August 20, 2015

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