Bronchial Asthma
Conditions
Interventions
Trade Name: Seretide 250 Evohaler
Product Name: Seretide 250 Evohaler
Pharmaceutical Form: Pressurised inhalation, suspension
Pharmaceutical form of the placebo: Pressurised inhalation, suspension
Rou
Sponsors
University of Dundee (Research & Innovation Services)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Volunteers 2. Male or female 18-65 3. Informed Consent 4. Ability to comply with the requirements of 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. No respiratory disease 2. Smokers 3. Recent respiratory tract infection (2 months). 4. Any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA/ CVA,that may endanger the health or safety of the participant, or jeopardise the protocol. 5. Any significant abnormal laboratory result as deemed by the investigators 6. Pregnancy, planned pregnancy or lactation 7. Known or suspected contra-indication to any of the IMP’s 8. Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.To establish whether, the systemic bioavailability of inhaled Seretide® HFA formulation is comparable via the pMDI, Volumatic®, and Synchrobreathe® devices.;Secondary Objective: ;Primary end point(s): 1.The primary endpoint will be overnight urinary cortisol to creatinine ratio as a surrogate for the lung bioavailability of the fluticasone moiety. | — |
Countries
United Kingdom
Outcome results
None listed