Trial intelligence / Profile preview

Mannitol vs Methacholine Responsiveness in Asthma

NCT01642745Phase 4

Key facts

Status: Completed
Start: Nov 2011
Primary completion: Feb 2013
Countries: 1
Sponsor: University of Saskatchewan
Modality: Orthosteric Ligands, Inhalation Devices

Drugs: Bronchitolmethacholine
Conditions: asthma

Overview

Phase 4, randomised, open-label trial of Bronchitol and methacholine in asthma (3 arms), sponsored by University of Saskatchewan. Primary endpoints: Airway responsiveness (PC20) to methacholine delivered over two minutes of tidal breathing, Airway responsiveness (PD15) to inhaled mannitol and 1 more. Started Nov 2011; status: completed.

Design

3 arms

Study design: RandomizedOpen-label

Methacholine (Deep Inhalation)
Methacholine challenge with deep inhalation
Mannitol
Mannitol dry powder challenge
Methacholine (Tidal)
Methacholine challenge with tidal breathing

Who it enrols

Patients with stable controlled asthma, excluding pregnant women and those using asthma therapies other than bronchodilators.

Endpoints

Primary

Airway responsiveness (PC20) to methacholine delivered over two minutes of tidal breathingVisit 1 (Day 1)
Airway responsiveness (PD15) to inhaled mannitolVisit 2 (up to 13 days)
Airway responsiveness (PC20) to deep inhalation methacholineVisit 3 (up to 14 days)

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