NCT03505489

The Effect of Deep Inhalation on Mannitol Responsiveness

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study will assess how the inhalation technique used (deep inhalations versus tidal breathing) influences the results of a mannitol challenge test and a methacholine challenge test, if at all.

Detailed description

This study will look at airway responsiveness to inhaled methacholine and mannitol administered with and without deep inhalation. This study will also investigate the role of airway inflammation on these responses, using sputum differential cell counts and fractional exhaled nitric oxide. This is a single center, open label, randomized study. Individuals with stable asthma will be eligible for enrollment. The study will consist of two parts, screening and testing. Part 1: Screening Participants will undergo consent procedures and assessments of fractional exhaled nitric oxide levels, airway responsiveness to methacholine and sputum induction. If participants show airway responsiveness to methacholine (i.e. methacholine PC20 16mg/mL), they will be scheduled to undergo the testing part of the study. Part 2: Testing Participants will be randomized to undergo two methacholine or two mannitol challenges. Further randomization will occur with respect to whether the standard challenge method or the modified challenge method is performed first.

Conditions

• Asthma

Interventions

Type	Name	Description
PROCEDURE	Deep inhalation technique	Use of deep inhalations for administration of inhalant
PROCEDURE	Tidal breathing technique	Use of tidal breathing for administration of inhalant
DRUG	Methacholine	Methacholine direct bronchoconstrictor used for bronchoprovocation challenge
DRUG	Mannitol	Mannitol indirect bronchoconstrictor used for bronchoprovocation challenge

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2018-04-23
• Last updated: 2019-05-15

Locations

1 site across 1 country: Canada