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

NCT00274560 | Completed Phase 3

• 1 other identifier: 205.264
• Study Type: interventional
• Target: 653
• Locations: 8 countries
• Sites: 50

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 .

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

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

  12 weeks

• peak FEV1

  12 weeks

Secondary Outcomes (11)

• Trough FEV1: Trough FEV1 was the FEV1 measured prior to dosing

  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

• Number (%) of patients with at least one exacerbation of COPD

  12 weeks

• time to first exacerbation

  12 weeks

Interventions

Tiotropium DRUG

Salmeterol DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (50)

UAB Medical Center

Birmingham, Alabama, United States

Location

Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Location

Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

Southern Arizona VA Health Care System

Tucson, Arizona, United States

Location

Boehringer Ingelheim Investigational Site

Fullerton, California, United States

Location

VA Greater Los angeles Health Care Systems

Sepulveda, California, United States

Location

Olive View UCLA Medical Center

Sylmar, California, United States

Location

Boehringer Ingelheim Investigational Site

Boulder, Colorado, United States

Location

Colorado Pulmonary Associates

Denver, Colorado, United States

Location

Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Location

Boehringer Ingelheim Investigational Site

Melbourne, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

University Medical Associates, LLP

Augusta, Georgia, United States

Location

Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

Location

LSU MC-Sheveport

Shreveport, Louisiana, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Location

The Oregon Clinic

Portland, Oregon, United States

Location

Temple University School of Medicine

Philadelphia, Pennsylvania, United States

Location

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

Charleston, South Carolina, United States

Location

Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

HEMO Oy Health Center

Lahti, Finland

Location

Boehringer Ingelheim Investigational Site

Mikkeli, Finland

Location

Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

Gen. Hosp. "Evangelismos",

Athens, Greece

Location

Gen. Hosp. of Chest Diseases "Sotiria"

Athens, Greece

Location

Gen. Hosp. of Chest Diseases"Sotiria"

Athens, Greece

Location

University Hospital of Ioannina

Ioannina, Greece

Location

General Hospital "Sismanoglio", 3rd Pneumonology Dpt

Maroussi, Athens, Greece

Location

General Hospital "Papanicolaou",

Thessaloniki, Greece

Location

Azienda Ospedaliera S. Martino

Genova, Italy

Location

A.O. Pisana

Pisa, Italy

Location

Hospital de Santa Maria

Lisbon, Portugal

Location

Hospital Pulido Valente

Lisbon, Portugal

Location

Hospital de São João

Porto, Portugal

Location

Centro Hospitalar de Vila Nova de Gaia

Vila Nova de Gaia, Portugal

Location

Lindesbergs lasarett

Lindesberg, Sweden

Location

Boehringer Ingelheim Investigational Site

Linköping, Sweden

Location

Vårdcentralen Brinken

Motala, Sweden

Location

Boehringer Ingelheim Investigational Site

Örebro, Sweden

Location

Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

Fysiologlaboratoriet

Stockholm, Sweden

Location

Boehringer Ingelheim Investigational Site

Uppsala, Sweden

Location

Gazi Universitesi Tip Fakultesi

Ankara, Turkey (Türkiye)

Location

Istanbul Universitesi Cerrahpasa Tip Fakültesi

Istanbul, Turkey (Türkiye)

Location

Yedikule Gögüs Hastaliklari Hastanesi

Istanbul, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi

Izmir, Turkey (Türkiye)

Location

Frenchay Healthcare NHS Trust

Bristol, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Glasgow, United Kingdom

Location

West Middlesex University Hospital

Isleworth, United Kingdom

Location

Medicines Evaluation Unit

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Study Officials

• Boehringer Ingelheim Study Coordinator

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2006
• First Posted: January 11, 2006
• Study Start: May 1, 2002
• Primary Completion: March 27, 2003
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

FI (3); GB (4); PT (4); SE (7); GR (6); US (20); TU (4); IT (2)