Dose response of FENO to inhaled steroids in mild-to-moderate asthma - Dose response of FENO to inhaled steroids in mild-to-moderate asthma

Phase 1

Conditions: Asthma
MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

Registration Number: EUCTR2009-012053-37-GB

Lead Sponsor: niversity of Dundee

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 25

Inclusion Criteria

Informed consent and ability to perform exhaled nitric oxide assessment and all domiciliary measurements. Asthmatics taking 200-1000µg BDP per day or equivalent with FENO>30ppb which rises by at least a further 10ppb following withdrawal of ICS.
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

Recent respiratory infection (4 weeks) or oral steroid use within 3 months. Pregnancy or lactation, COPD, smoking within one year or >10pack years, known or suspected contra-indication to any of the IMP’s, potent CYP3A4 inhibitors/inducers

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterise dose-response, as assessed by exhaled nitric oxide following administration of fluticasone propionate at 2 doses (50µg b.i.d. and 250µg b.i.d.) in mild to moderate adult asthmatics.;Secondary Objective: Maximal change in FENO over 14 days; time required to reach 90% of maximal change; rate of change in FENO; change in diurnal variation in FENO; symptom scores; following 2 weeks therapy fractionated exhaled nitric oxide, impulse oscillometry, ECP, EDN, peripheral eosinophils and mannitol challenge;Primary end point(s): Change from baseline as mean morning FENO over last 3 days of treatment.

Secondary Outcome Measures