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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274560
• Other study ID #: 205.264
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2002

Study information

• Verified date: November 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 653
• Est. primary completion date: March 27, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

Drug:
• Tiotropium

• Salmeterol

Locations

Country	Name	City	State
Finland	HEMO Oy Health Center	Lahti
Finland	Boehringer Ingelheim Investigational Site	Mikkeli
Finland	Boehringer Ingelheim Investigational Site	Oulu
Greece	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
Italy	Azienda Ospedaliera S. Martino	Genova
Italy	A.O. Pisana	Pisa
Portugal	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
Sweden	Lindesbergs lasarett	Lindesberg
Sweden	Boehringer Ingelheim Investigational Site	Linköping
Sweden	Vårdcentralen Brinken	Motala
Sweden	Boehringer Ingelheim Investigational Site	Örebro
Sweden	Boehringer Ingelheim Investigational Site	Stockholm
Sweden	Fysiologlaboratoriet	Stockholm
Sweden	Boehringer Ingelheim Investigational Site	Uppsala
Turkey	Gazi Universitesi Tip Fakultesi	Ankara
Turkey	Istanbul Universitesi Cerrahpasa Tip Fakültesi	Istanbul
Turkey	Yedikule Gögüs Hastaliklari Hastanesi	Istanbul
Turkey	Ege Universitesi Tip Fakultesi	Izmir
United Kingdom	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 States	University Medical Associates, LLP	Augusta	Georgia
United States	UAB Medical Center	Birmingham	Alabama
United States	Boehringer Ingelheim Investigational Site	Boulder	Colorado
United States	Attention: Thomas D. Kaelin, Jr., D.O.	Charleston	South Carolina
United States	Boehringer Ingelheim Investigational Site	Coeur d'Alene	Idaho
United States	Colorado Pulmonary Associates	Denver	Colorado
United States	Boehringer Ingelheim Investigational Site	Fullerton	California
United States	Boehringer Ingelheim Investigational Site	Houston	Texas
United States	Boehringer Ingelheim Investigational Site	Jasper	Alabama
United States	Boehringer Ingelheim Investigational Site	Melbourne	Florida
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Boehringer Ingelheim Investigational Site	Pembroke Pines	Florida
United States	Temple University School of Medicine	Philadelphia	Pennsylvania
United States	Boehringer Ingelheim Investigational Site	Phoenix	Arizona
United States	The Oregon Clinic	Portland	Oregon
United States	VA Greater Los angeles Health Care Systems	Sepulveda	California
United States	LSU MC-Sheveport	Shreveport	Louisiana
United States	Olive View UCLA Medical Center	Sylmar	California
United States	Southern Arizona VA Health Care System	Tucson	Arizona
United States	Boehringer Ingelheim Investigational Site	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Finland,  Greece,  Italy,  Portugal,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 area under the curve for the time period of 0 to 12 hours (FEV1 AUC0-12)		12 weeks
Primary	peak FEV1		12 weeks
Secondary	Trough FEV1: Trough FEV1 was the FEV1 measured prior to dosing		12 weeks
Secondary	Trough and peak FVC and FVC AUC0-12 measured at the same times as FEV1 on each test day		12 weeks
Secondary	Individual FEV1 and FVC measurements at each timepoint		12 weeks
Secondary	Number (%) of patients with at least one exacerbation of COPD		12 weeks
Secondary	time to first exacerbation		12 weeks
Secondary	number of exacerbations		12 weeks
Secondary	number of exacerbation days		12 weeks
Secondary	Average daily occasions of rescue medication [albuterol (salbutamol)] use each week		12 weeks
Secondary	All adverse events		12 weeks
Secondary	Pulse rate measured in conjunction with spirometry		12 weeks
Secondary	Blood pressure (seated) measured in conjunction with spirometry		12 weeks