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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012053-37-GB

Enrollment

Registered

2009-09-17

Start date

2009-08-14

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma

Interventions

Trade Name: Flixotide 50 micrograms Evohaler Product Name: Flixotide 50 micrograms Evohaler Product Code: PL 10949/0324 Pharmaceutical Form: Inhalation vapour, solution INN or Proposed INN: FLUTICASON

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026