Trial intelligence / Profile preview

OLiVIA: HFA-QVAR in Asthmatic Smokers

NCT01741285Phase 4

Key facts

Status: Completed
Start: Apr 2013
Primary completion: Jul 2015
Countries: 1
Sponsor: University Medical Center Groningen
Modality: Small Molecules

Drugs: beclomethasone dipropionate
Conditions: asthma

Overview

Phase 4, randomised, open-label trial of beclomethasone dipropionate in asthma (3 arms), sponsored by University Medical Center Groningen. Primary endpoints: Provocative Dose of Adenosine causing 20% drop in FEV1 at 2 weeks and Decrease in Peripheral Airways Resistance (R5-R20) at PD20 Adenosine at 2 weeks. Started Apr 2013; status: completed.

Design

3 arms

Study design: RandomizedOpen-label

HFA-QVAR
Extra-fine particle beclomethasone 200 µg b.i.d.
HFA-Clenil
Coarse particle beclomethasone 400 µg b.i.d.
HFA-Fluticasone
Coarse particle fluticasone 250 µg b.i.d.

Who it enrols

Adult smokers and ex-smokers with asthma, aged 18-65, with >= 5 packyears and demonstrated airway hyperresponsiveness to adenosine.

Endpoints

Primary

Provocative Dose of Adenosine causing 20% drop in FEV12 weeks
Decrease in Peripheral Airways Resistance (R5-R20) at PD20 Adenosine2 weeks

Secondary

Asthma Symptoms2 weeks
Peak Expiratory Flow2 weeks
Airway Resistance2 weeks
Spirometry Parameters2 weeks
Peripheral Blood Analysis2 weeks
Change in FVC during PD20 small particle adenosine2 weeks
Quality of Life Questionnaires2 weeks
Multiple Breath Washout Analysis2 weeks

Beyond the preview

Go deeper on NCT01741285.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT01741285.