Effect of inhalation of tiotropium once daily 18 mcg versus salmeteroltwice daily 50 mcg on time to first exacerbation in COPD patients (arandomised, double-blind, double-dummy, parallel group, one-yearstudy). - POET
- Conditions
- chronic obstructive pulmonary disease (COPD)MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD
- Registration Number
- EUCTR2007-001840-33-SK
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 6800
1. 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% of predicted normal and FEV1 = 70% 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
2. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial.
3. Male or female patients 40 years of age or older.
4. Patients with a history of at least one exacerbation within the past year requiring
treatment with either antibiotics and/or steroids and/or hospitalisation.
5. 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
6. Patients must be able to perform all study-related procedures including technically
acceptable pulmonary function tests (PFTs).
7. 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).
8. 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:
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
1. 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.
2. Patients with a diagnosis of asthma.
3. Patients with a life-threatening pulmonary obstruction, or a history of cystic fibrosis.
4. Patients with known active tuberculosis.
5. 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.
6. Patients with known narrow-angle glaucoma.
7. Patients with a history of myocardial infarction within the year prior to Visit 1.
8. Patients with a history of hospital admission for heart failure within the year prior to Visit 1.
9. Patients with cardiac arrhythmia requiring medical or surgical treatment.
10. Patients with severe cardiovascular disorders.
11. Patients with a known hypersensitivity to anticholinergic drugs, beta-adrenergics,
lactose or any other component of the medication delivery system.
12. Patients with known moderate or severe renal insufficiency (known creatinine clearance of = 50 mL/min).
13. Patients with untreated known hypokalaemia.
14. Patients with untreated known thyrotoxicosis.
15. Patients with brittle/unstable diabetes mellitus.
16. Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion 1.
17. Patients who have taken an investigational drug within 30 days or six half-lives
(whichever is greater) prior to Screening Visit (Visit 1).
18. Use of systemic corticosteroid medication at unstable doses (i.e less than six weeks on stable dose) or at doses in excess of the equivalent of 10 mg prednisolone per day or 20 mg every other day.
19. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e oral contraceptives, intrauterine devices, diaphragm or subdermal implants e.g Norplant®) for at least three months prior to, and for the duration of the trial.
20. Previous participation (receipt of randomised treatment) in this study.
21. Patients who are currently participating in another study.
22. Patients with any respiratory infection or COPD exacerbation in the four weeks prior to the Screening Visit (Visit 1) or during the run-in period should be postponed. In the case of a respiratory infection or COPD exacerbation during the run-in period, the latter may be extended up to four weeks.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method