Severe refractory asthma. MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: Qvar Easibreathe 100 micrograms per actuation
Product Name: Qvar Easibreathe 100
Pharmaceutical Form: Inhalation vapour, solution
Trade Name: Flixotide 250micrograms/dose
Product Name: Fl
Sponsors
The University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Refractory, non-smoking asthmatics with FEV1 (forced expiratory volume in 1 second)100% predicted and CANO (calculated alveolar nitric oxide) >3ppb when stepped up to 1000µg of fluticasone per day, with or without additional asthma medication. Informed consent and ability to perform exhaled nitric oxide assessment. Participants must be on >500mcg of fluticasone per day to enter dose ramp run-in. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) 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: Recent respiratory infection or oral steroid use. Pregnancy or lactation. Known or suspected contra-indication to any of the IMP’s. CANO 80% or RV<100% at post-optimisation visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish whether addition of extra-fine particle BDP (Qvar) or course particle inhaled corticosteroids achieve additional suppression of small airways inflammation when added to Fluticasone/Salmeterol (Seretide) combination therapy in refractory asthma.;Secondary Objective: ;Primary end point(s): Suppression of alveolar nitric oxide (CANO), used as a surrogate of small airways inflammation. | — |
Countries
United Kingdom
Outcome results
None listed