A Proof of Concept Study to Evaluate the Additive Effects of HFA-BDP (Qvar) to fluticasone/salmeterol (Seretide) on Surrogate Markers of Small and Large Airway Inflammation in Refractory Asthma - PAW01

Conditions: Severe refractory asthma.
MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

Registration Number: EUCTR2008-001811-40-GB

Lead Sponsor: The University of Dundee

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

Refractory, non-smoking asthmatics with FEV1 (forced expiratory volume in 1 second)<80% predicted, RV (residual lung volume) >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

Recent respiratory infection or oral steroid use. Pregnancy or lactation. Known or suspected contra-indication to any of the IMP’s. CANO <3ppb, FEV1>80% or RV<100% at post-optimisation visit.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures