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

NCT ID: NCT00274560

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

653 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-01

Brief Summary

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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

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tiotropium

Intervention Type DRUG

Salmeterol

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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UAB Medical Center

Birmingham, Alabama, United States

Site Status

Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Site Status

Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Site Status

Southern Arizona VA Health Care System

Tucson, Arizona, United States

Site Status

Boehringer Ingelheim Investigational Site

Fullerton, California, United States

Site Status

VA Greater Los angeles Health Care Systems

Sepulveda, California, United States

Site Status

Olive View UCLA Medical Center

Sylmar, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Boulder, Colorado, United States

Site Status

Colorado Pulmonary Associates

Denver, Colorado, United States

Site Status

Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Site Status

Boehringer Ingelheim Investigational Site

Melbourne, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Site Status

University Medical Associates, LLP

Augusta, Georgia, United States

Site Status

Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

Site Status

LSU MC-Sheveport

Shreveport, Louisiana, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

The Oregon Clinic

Portland, Oregon, United States

Site Status

Temple University School of Medicine

Philadelphia, Pennsylvania, United States

Site Status

Attention: Thomas D. Kaelin, Jr., D.O.

Charleston, South Carolina, United States

Site Status

Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

HEMO Oy Health Center

Lahti, , Finland

Site Status

Boehringer Ingelheim Investigational Site

Mikkeli, , Finland

Site Status

Boehringer Ingelheim Investigational Site

Oulu, , Finland

Site Status

Gen. Hosp. "Evangelismos",

Athens, , Greece

Site Status

Gen. Hosp. of Chest Diseases "Sotiria"

Athens, , Greece

Site Status

Gen. Hosp. of Chest Diseases"Sotiria"

Athens, , Greece

Site Status

University Hospital of Ioannina

Ioannina, , Greece

Site Status

General Hospital "Sismanoglio", 3rd Pneumonology Dpt

Maroussi, Athens, , Greece

Site Status

General Hospital "Papanicolaou",

Thessaloniki, , Greece

Site Status

Azienda Ospedaliera S. Martino

Genova, , Italy

Site Status

A.O. Pisana

Pisa, , Italy

Site Status

Hospital de Santa Maria

Lisbon, , Portugal

Site Status

Hospital Pulido Valente

Lisbon, , Portugal

Site Status

Hospital de São João

Porto, , Portugal

Site Status

Centro Hospitalar de Vila Nova de Gaia

Vila Nova de Gaia, , Portugal

Site Status

Lindesbergs lasarett

Lindesberg, , Sweden

Site Status

Boehringer Ingelheim Investigational Site

Linköping, , Sweden

Site Status

Vårdcentralen Brinken

Motala, , Sweden

Site Status

Boehringer Ingelheim Investigational Site

Örebro, , Sweden

Site Status

Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

Fysiologlaboratoriet

Stockholm, , Sweden

Site Status

Boehringer Ingelheim Investigational Site

Uppsala, , Sweden

Site Status

Gazi Universitesi Tip Fakultesi

Ankara, , Turkey (Türkiye)

Site Status

Istanbul Universitesi Cerrahpasa Tip Fakültesi

Istanbul, , Turkey (Türkiye)

Site Status

Yedikule Gögüs Hastaliklari Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Ege Universitesi Tip Fakultesi

Izmir, , Turkey (Türkiye)

Site Status

Frenchay Healthcare NHS Trust

Bristol, , United Kingdom

Site Status

Boehringer Ingelheim Investigational Site

Glasgow, , United Kingdom

Site Status

West Middlesex University Hospital

Isleworth, , United Kingdom

Site Status

Medicines Evaluation Unit

Manchester, , United Kingdom

Site Status

Countries

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United States Finland Greece Italy Portugal Sweden Turkey (Türkiye) United Kingdom

Other Identifiers

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205.264

Identifier Type: -

Identifier Source: org_study_id