asthma bronchiale
Conditions
Interventions
Product Name: salmeterol
Pharmaceutical Form: Inhalation powder
Trade Name: Serevent
Pharmaceutical Form: Inhalation powder
Sponsors
Merck Generics UK Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria At study entry: 1. Male and female asthmatic patients, aged 18 - 55 years inclusive. 2. Documented asthma for at least 6 months before screening. 3. Subjects with a FEV1 of at least 50% of the predicted normal value for age, height and gender. 4. Subjects who demonstrate a reversibility of > 12% in FEV1 10 minutes after a dose of 200?g salbutamol from a standard salbutamol pMDI, after withholding short acting ?2-agonists for at least 6 hours and long acting ?2-agonists for at least 7 x 24 hours. 5. Subjects who are able to use a pMDI correctly without the aid of an air chamber. 6. Subjects who are willing to give written informed consent to participate in the study. On study days: 1. A pre-dose baseline FEV1 within 10% of the value obtained at the Screening Visit. 2. Increase of at least 12% in FEV1 60 minutes after the first dose of the study medication. 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 Patients currently receiving oral corticosteroid therapy or who have received oral corticosteroid therapy in the 3 months preceding the screening. 2. Patients currently receiving therapy for an upper respiratory tract infection or who have received such a therapy in the month prior to the start of the study. 3. Patients who have been hospitalised or received emergency treatment for an exacerbation of asthma in the 3 months prior to the start of the study. 4. Patients who have experienced bronchospasms following the administration of HFA-134a containing products. 5. Patients with a known or suspected hypersensitivity to salmeterol or it’s excipients. 6. Patients who are unable to perform lung function tests. 7. Patients with any of the following concurrent conditions: • Uncontrolled diabetes mellitus • Evidence of current neoplastic disease other than basal cell carcinoma • Evidence of tuberculosis • Evidence of significant cardiovascular disease • Respiratory disorders other than asthma or rhinitis • Significant hepatic or renal insufficiency • Evidence or history of alcohol or drug abuse • Evidence or history of low potassium levels 8. Patients currently receiving the following concomitant medication: - anticholinergics - theophylline and other methylxanthines - long acting ?2-agonists 9. Patients currently receiving other investigational medication or who have received investigational medication in the month prior to the screening of the study. 10 Employees of Merck Generics [UK] Ltd or the CRO responsible for the execution of the study. 11. Women who are pregnant, lactating or likely to become pregnant during the course of the study. Women of child bearing potential will be eligible to enter the study if using adequate contraception (i.e. contraceptive pill or barrier methods).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): • Change in FEV1 at 1 hour, 2h10 mins and 3h 20mins after administration of study medication relative to the baseline value (before administration of study medication).;Main Objective: The primary aim of the study is: To assess the therapeutic equivalence of a new salmeterol HFA-134a formulation compared to a reference salmeterol CFC formulation given in a cumulative dose design. ;Secondary Objective: The secondary aim of the study is: To evaluate the safety and tolerability of the new HFA-134a containing salmeterol formulation. | — |
Countries
Hungary
Outcome results
None listed