A single dose, placebo-controlled, randomized, double-blind, double-dummy, crossover efficacy, pharmacokinetics and safety comparison of salmeterol inhalation powder (12.5 µg, 25 µg and 50 µg salmeterol), administered as the xinafoate salt from hard polyethylene capsules via the HandiHaler(R) 2, and Serevent(R) Diskus(R) (50 µg salmeterol) in patients with chronic obstructive pulmonary disease (COPD) - Efficacy, pharmacokinetics and safety of salmeterol inhalation powder, hard capsules
- Conditions
- All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a pre-dose FEV1 equal to or below 60% of predicted normal, and FEV1 equal to or below 70% of FVC at Visits 1 and 2.MedDRA version: 8.0Level: LLTClassification code 10010952
- Registration Number
- EUCTR2005-000918-13-DE
- 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
- 110
1. All patients must sign an informed consent consistent with ICH-GCP guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions.
2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a pre-dose FEV1 equal to or below 60% of predicted normal and FEV1 equal to or below 70% of FVC at Visits 1 and 2.
3. At Visit 1, patients must demonstrate an improvement in FEV1 of >= 12% over the baseline value 45 minutes after inhalation of 4 puffs of 100 µg salbutamol (Sultanol® MDI).
4. Male or female patients 40 years of age or older.
5. Patients must be current or ex-smokers with a smoking history of more than 10 pack-years.
6. Patients must be able to perform technically acceptable pulmonary function tests during the study period as required in the protocol.
7. Patients must be able to inhale medication in a competent manner from the HandiHaler 2 device and the Diskus device.
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. Patients with significant diseases other than COPD will be excluded.
2. Patients with a recent history (i.e., six months or less) of myocardial infarction.
3. Patients who have been hospitalized for heart failure (NYHA class III or IV) within the past year.
4. Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
5. Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
6. Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count >= 600/mm3. A repeat eosinophil count will not be conducted in these patients.
7. Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
8. Patients with known active tuberculosis.
9. Patients with significant alcohol or drug abuse within the past two years.
10. Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1.
11. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study.
12. Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator’s opinion will be unable to abstain from the use of oxygen therapy.
13. Patients who are being treated with antihistamines (H1 receptor antagonists), antileukotrienes or leukotriene receptor antagonists for asthma or excluded allergic conditions.
14. Patients who have been treated with cromolyn sodium or nedocromil sodium within one month prior to Visit 1 or during the run-in period.
15. Patients using oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
16. Patients with known hypersensitivity to beta-adrenergics, lactose or any other components of the inhalation powder delivery system or the Diskus.
17. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception for the previous three months.
18. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Visit 1.
19. Patients who have been treated with oral beta-adrenergics within one month prior to Visit 1 or during the run-in period.
20. Patients who have been treated with theophylline preparations within one month prior to Visit 1 or during the run-in period.
21. Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®) within one month prior to Visit 1 or during the run-in period.
22. Patients with any respiratory infections in the six weeks prior to the Screening Visit (Visit 1) or during the run-in period. In the case of a respiratory infection during the run in period the latter may be extended up to six weeks.
23. Patients who are currently participating in another study.
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