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).
NCT number | NCT00274560 |
Other study ID # | 205.264 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 1, 2002 |
Verified date | November 2023 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 .
Status | Completed |
Enrollment | 653 |
Est. completion date | |
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
United States, Finland, Greece, Italy, Portugal, Sweden, Turkey, United Kingdom,
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 |
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