Clinical trial NCT00274560: A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-01-11
Enrollment: 653
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .


Eligibility criteria: 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.

Primary outcomes:
measure: FEV1 area under the curve for the time period of 0 to 12 hours (FEV1 AUC0-12)
timeFrame: 12 weeks
measure: peak FEV1
timeFrame: 12 weeks
Secondary outcomes:
measure: Trough FEV1: Trough FEV1 was the FEV1 measured prior to dosing
timeFrame: 12 weeks
measure: Trough and peak FVC and FVC AUC0-12 measured at the same times as FEV1 on each test day
timeFrame: 12 weeks
measure: Individual FEV1 and FVC measurements at each timepoint
timeFrame: 12 weeks
measure: Number (%) of patients with at least one exacerbation of COPD
timeFrame: 12 weeks
measure: time to first exacerbation
timeFrame: 12 weeks
measure: number of exacerbations
timeFrame: 12 weeks
measure: number of exacerbation days
timeFrame: 12 weeks
measure: Average daily occasions of rescue medication [albuterol (salbutamol)] use each week
timeFrame: 12 weeks
measure: All adverse events
timeFrame: 12 weeks
measure: Pulse rate measured in conjunction with spirometry
timeFrame: 12 weeks
measure: Blood pressure (seated) measured in conjunction with spirometry
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Medical Center
state: Alabama
city: Jasper
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Fullerton
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Sepulveda
country: United States
facility: VA Greater Los angeles Health Care Systems
state: California
city: Sylmar
country: United States
facility: Olive View UCLA Medical Center
state: California
city: Boulder
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Colorado
city: Denver
country: United States
facility: Colorado Pulmonary Associates
state: Colorado
city: Wheat Ridge
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Colorado
city: Melbourne
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Augusta
country: United States
facility: University Medical Associates, LLP
state: Georgia
city: Coeur d'Alene
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Idaho
city: Shreveport
country: United States
facility: LSU MC-Sheveport
state: Louisiana
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Philadelphia
country: United States
facility: Temple University School of Medicine
state: Pennsylvania
city: Charleston
country: United States
facility: Attention: Thomas D. Kaelin, Jr., D.O.
state: South Carolina
city: Houston
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Lahti
country: Finland
facility: HEMO Oy Health Center
city: Mikkeli
country: Finland
facility: Boehringer Ingelheim Investigational Site
city: Oulu
country: Finland
facility: Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: Gen. Hosp. "Evangelismos",
city: Athens
country: Greece
facility: Gen. Hosp. of Chest Diseases "Sotiria"
city: Athens
country: Greece
facility: Gen. Hosp. of Chest Diseases"Sotiria"
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
city: Maroussi, Athens
country: Greece
facility: General Hospital "Sismanoglio", 3rd Pneumonology Dpt
city: Thessaloniki
country: Greece
facility: General Hospital "Papanicolaou",
city: Genova
country: Italy
facility: Azienda Ospedaliera S. Martino
city: Pisa
country: Italy
facility: A.O. Pisana
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
city: Lisboa
country: Portugal
facility: Hospital Pulido Valente
city: Porto
country: Portugal
facility: Hospital de São João
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia
city: Lindesberg
country: Sweden
facility: Lindesbergs lasarett
city: Linköping
country: Sweden
facility: Boehringer Ingelheim Investigational Site
city: Motala
country: Sweden
facility: Vårdcentralen Brinken
city: Stockholm
country: Sweden
facility: Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: Fysiologlaboratoriet
city: Uppsala
country: Sweden
facility: Boehringer Ingelheim Investigational Site
city: Örebro
country: Sweden
facility: Boehringer Ingelheim Investigational Site
city: Ankara
country: Turkey
facility: Gazi Universitesi Tip Fakultesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakültesi
city: Istanbul
country: Turkey
facility: Yedikule Gögüs Hastaliklari Hastanesi
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi
city: Bristol
country: United Kingdom
facility: Frenchay Healthcare NHS Trust
city: Glasgow
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site
city: Isleworth
country: United Kingdom
facility: West Middlesex University Hospital
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: