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

November 30, 2023 updated by: Boehringer Ingelheim

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).

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

653

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Lahti, Finland
        • HEMO Oy Health Center
      • Mikkeli, Finland
        • Boehringer Ingelheim Investigational Site
      • Oulu, Finland
        • Boehringer Ingelheim Investigational Site
  • Greece
      • Athens, Greece
        • Gen. Hosp. "Evangelismos",
      • Athens, Greece
        • Gen. Hosp. of Chest Diseases "Sotiria"
      • Athens, Greece
        • Gen. Hosp. of Chest Diseases"Sotiria"
      • Ioannina, Greece
        • University Hospital of Ioannina
      • Maroussi, Athens, Greece
        • General Hospital "Sismanoglio", 3rd Pneumonology Dpt
      • Thessaloniki, Greece
        • General Hospital "Papanicolaou",
  • Italy
      • Genova, Italy
        • Azienda Ospedaliera S. Martino
      • Pisa, Italy
        • A.O. Pisana
  • Portugal
      • Lisboa, Portugal
        • Hospital de Santa Maria
      • Lisboa, Portugal
        • Hospital Pulido Valente
      • Porto, Portugal
        • Hospital de Sao Joao
      • Vila Nova de Gaia, Portugal
        • Centro Hospitalar de Vila Nova de Gaia
  • Sweden
      • Lindesberg, Sweden
        • Lindesbergs lasarett
      • Linköping, Sweden
        • Boehringer Ingelheim Investigational Site
      • Motala, Sweden
        • Vårdcentralen Brinken
      • Stockholm, Sweden
        • Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • Fysiologlaboratoriet
      • Uppsala, Sweden
        • Boehringer Ingelheim Investigational Site
      • Örebro, Sweden
        • Boehringer Ingelheim Investigational Site
  • Turkey
      • Ankara, Turkey
        • Gazi Universitesi Tip Fakultesi
      • Istanbul, Turkey
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi
      • Istanbul, Turkey
        • Yedikule Gögüs Hastaliklari Hastanesi
      • Izmir, Turkey
        • Ege Universitesi Tip Fakultesi
  • United Kingdom
      • Bristol, United Kingdom
        • Frenchay Healthcare NHS Trust
      • Glasgow, United Kingdom
        • Boehringer Ingelheim Investigational Site
      • Isleworth, United Kingdom
        • West Middlesex University Hospital
      • Manchester, United Kingdom
        • Medicines Evaluation Unit
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • UAB Medical Center
      • Jasper, Alabama, United States
        • Boehringer Ingelheim Investigational Site
    • Arizona
      • Phoenix, Arizona, United States
        • Boehringer Ingelheim Investigational Site
      • Tucson, Arizona, United States
        • Southern Arizona VA Health Care System
    • California
      • Fullerton, California, United States
        • Boehringer Ingelheim Investigational Site
      • Sepulveda, California, United States
        • VA Greater Los angeles Health Care Systems
      • Sylmar, California, United States
        • Olive View UCLA Medical Center
    • Colorado
      • Boulder, Colorado, United States
        • Boehringer Ingelheim Investigational Site
      • Denver, Colorado, United States
        • Colorado Pulmonary Associates
      • Wheat Ridge, Colorado, United States
        • Boehringer Ingelheim Investigational Site
    • Florida
      • Melbourne, Florida, United States
        • Boehringer Ingelheim Investigational Site
      • Pembroke Pines, Florida, United States
        • Boehringer Ingelheim Investigational Site
    • Georgia
      • Augusta, Georgia, United States
        • University Medical Associates, LLP
    • Idaho
      • Coeur d'Alene, Idaho, United States
        • Boehringer Ingelheim Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • LSU MC-Sheveport
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland, Oregon, United States
        • The Oregon Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Temple University School of Medicine
    • South Carolina
      • Charleston, South Carolina, United States
        • Attention: Thomas D. Kaelin, Jr., D.O.
    • Texas
      • Houston, Texas, United States
        • Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Ability to sign a written Informed Consent Form consistent with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial (i.e., prior to any study procedures, including any pre-study washout of medications).
  • Age of 40 years or older.
  • Smoking history of ≥10 pack-years.
  • A diagnosis of relatively stable chronic obstructive pulmonary disease with an Forced expiratory volume in one second (FEV1) ≤60% of predicted normal and FEV1 ≤70% of Forced vital capacity (FVC).
  • Ability to perform technically acceptable pulmonary function tests, and ability to maintain records during the study period as required in the protocol.
  • Ability to inhale medication from the HandiHaler® and from a metered dose inhaler.

Exclusion criteria:

  • Clinically significant diseases other than Chronic obstructive pulmonary disease (COPD). A clinically significant disease was defined as a disease or condition which, in the opinion of the investigator, could have put the patient at risk because of participation in the study or may have influenced either the results of the study or the patient's ability to participate in the study.
  • Known moderate or severe renal insufficiency.
  • A recent history (i.e., six months or less) of myocardial infarction.
  • Unstable or life-threatening cardiac arrhythmias, including newly diagnosed, clinically relevant arrhythmia on the electrocardiogram (ECG) performed on Visit 1. Unstable arrhythmias included arrhythmias that required an intervention (i.e., hospitalization, cardioversion, pacemaker placement, and automatic implantable cardiac defibrillator (AICD) placement) or a change in drug therapy during the year preceding study enrollment.
  • Hospitalization for heart failure during the past three years.
  • History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
  • Other exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FEV1 area under the curve for the time period of 0 to 12 hours (FEV1 AUC0-12)
Time Frame: 12 weeks
12 weeks
peak FEV1
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim Study Coordinator, Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2002

Primary Completion (Actual)

March 27, 2003

Study Registration Dates

First Submitted

January 9, 2006

First Submitted That Met QC Criteria

January 9, 2006

First Posted (Estimated)

January 11, 2006

Study Record Updates

Last Update Posted (Actual)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.264

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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