Asthma
Conditions
Interventions
Product Name: Test IMP (FP/SM 125/25 pMDI)
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: Salmeterol xinafoate
CAS Number: 94749-08-3
Concentration unit: µg microgram(s)
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent given by patient. 2. Male or female patients between 18 and 65 years of age inclusive. 3. Persistent stable asthmatics (FEV1 > 60%) on = 1000 µg FP or equivalent or if on combination therapy up to 500 µg of FP or equivalent (e.g. FP/SM 125 2-puffs BD or BUD/FM 200/6 2-puffs BD) 4. Patients suffering from stable, persistent, mild to moderate asthma as defined by GINA Guidelines and for whom FEV1 > 60 % 5. Methacholine PC20 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Severe asthmatics as defined by an FEV1 30% or with continual daytime or nocturnal symptoms. 2. Known or suspected hypersensitivity to FP or any other constituents of the Test or Reference pMDI 3. Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the patient or which might interfere with the study (such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA / CVA). 4. Females who are pregnant, lactating or planning to become pregnant. 5. Approximately half of the subjects will be smokers and half currently non-smokers (or who have ceased smoking at least 1 year previously). 6. Clinically significant laboratory values, as judged by the investigator. 7. Patients who have previously been enrolled into this study. 8. Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the screening visit. 9. Patients who are scheduled to receive any other investigational drug during the course of the study. 10. Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial. 11. Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months. 12. Respiratory tract infection in the previous 2 months. 13. Patients with significant concomitant respiratory disease such as COPD, CF, ABPA, active pulmonary TB or bronchiectesis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the effect of the two treatments on airway responsiveness to methacholine. ;Secondary Objective: Secondary objectives will be effects on salbutamol recovery following methacholine challenge, mannitol challenge, assessment of the effect of the two treatments on spirometry, exhaled nitric oxide, asthma symptoms, peak flow, peripheral blood eosinophils and serum eosinophilic cationic protein, Bmax, Emax, IOS (Impulse oscillometry) and overnight urinary cortisol/creatinine. Safety assessments will be vital signs, laboratory assessments and adverse events.;Primary end point(s): Primary Efficacy Endpoint: Change from placebo baseline in methacholine airway responsiveness measured as doubling dilution shift in PC20 for each treatment | — |
Countries
United Kingdom
Outcome results
None listed