Mannitol (Aridol) and Methacholine (Provocholine) Responsiveness

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Methacholine (Provocholine); Drug: Mannitol (Aridol)

• Registration Number: NCT01642745
• Lead Sponsor: University of Saskatchewan

Brief Summary

The study will compare the airway responses to two bronchoconstricting agents, mannitol and methacholine.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-07-13
• Study First Posted: 2012-07-17
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• stable controlled asthma

Exclusion Criteria

• pregnancy
• use of asthma therapies other than bronchodilator therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Methacholine (Provocholine) tidal breathing	Methacholine (Provocholine)	-
Mannitol (Aridol)	Mannitol (Aridol)	-
Methacholine (Provocholine) with deep inhalation	Methacholine (Provocholine)	-

Primary Outcome Measures

Name	Time	Method
airway responsiveness (PD15) to inhaled mannitol	Visit 2 = up to 13 days	The PD15 to mannitol will be captured once at either visit 2 or visit 3.
Airway responsiveness (PC20) to methacholine delivered over two minutes of tidal breathing	Visit 1 (Day 1)	The two minute tidal breathing PC20 with be captured once at visit 1.
Airway responsiveness (PC20) to deep inhalation methacholine	Visit 3 = up to 14 days	The PC20 to methacholine (deep inhalation) will be captured once at either visit 2 or visit 3.

Trial Locations

Locations (1)

University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada