Effect of inhalation of tiotropium once daily 18 mcg versus salmeterol twice daily 50 mcg on time to first exacerbation in COPD patients (a randomised, double-blind, double-dummy, parallel group, one-year study)
- Conditions
- COPDMedDRA version: 14.1Level: PTClassification code 10061877Term: Obstructive airways disorderSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2007-001840-33-IT
- Lead Sponsor
- BOEHRINGER ING.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 6800
All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) and must meet the following criteria at Visit 1: Patients must have relatively stable, moderate to very severe airway obstruction with a post-bronchodilator FEV1 < 70 percent of predicted normal and FEV1 < 70 percent of FVC postbronchodilator (i.e. 30 minutes after inhalation of 4 puffs of 100 μg salbutamol or equivalent SABA). Predicted normal values will be calculated according to ECSC [R94-1408]. For Height measured in inches Males: FEV1 predicted (L) = 4.30 x (height (inches) / 39.37)-0.029 x age (yrs) - 2.49 Females: FEV1 predicted (L) = 3.95 x (height (inches) / 39.37)-0.025 x age (yrs) - 2.60 For Height measured in metres Males: FEV1 predicted (L) = 4.30 x (height (metres)) - 0.029 x age (years) -2.49 Females: FEV1 predicted (L) = 3.95 x (height (metres))- 0.025 x age (years) - 2.60
All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial.
Male or female patients 40 years of age or older.
Patients with a history of at least one exacerbation within the past year requiring treatment with either antibiotics and/or steroids and/or hospitalisation.
Patients must be current or ex-smokers with a smoking history of > 10 pack-years. (Patients who have never smoked cigarettes must be excluded.) Pack Years = (Number of cigarettes/day)/20 x years of smoking
Patients must be able to perform all study-related procedures including technically acceptable pulmonary function tests (PFTs).
Patients must be able to inhale medication in a competent manner from the HandiHaler (Appendix 10.1) and a metered dose inhaler (MDI) (Appendix 10.2).
Patients must be able to maintain records (patient daily diary card) during the study period as required in the protocol
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patients' ability to participate in the study.
Patients with a diagnosis of asthma. Patients with a life-threatening pulmonary obstruction, or a history of cystic fibrosis.
Patients with known active tuberculosis.
Patients with a known symptomatic prostatic hyperplasia or bladder neck obstruction. Patients with symptomatically-controlled prostatic hyperplasia on medication may be included and should continue their medication.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effect of tiotropium (18 mcg) inhalation capsule via HandiHaler and salmeterol (50 mcg) via MDI on COPD exacerbations.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is the time to first COPD exacerbation. For the purpose of this study a COPD exacerbation will be defined as: a complex of respiratory events symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnoea or chest tightness with a duration of at least three days requiring treatment with antibiotics and/or systemic steroids and/or hospital admission.
- Secondary Outcome Measures
Name Time Method