The Effect of Deep Inhalation on Mannitol Responsiveness

Asthma Clinical Trial

Official title:

The Effect of Deep Inhalation on Mannitol Responsiveness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03505489
• Other study ID #: MAN-2018
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: May 2019
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• signed informed consent

• men and women between 18 and 75 years of age

• FEV1 at first measurement of greater than or equal to 65% predicted

• methacholine provocative concentration causing a 20% in FEV1 at screening that is less than or equal to 16mg/ml

• generally good health

• stable asthma

Exclusion Criteria:

• respiratory infection within 4 weeks of screening visit

• worsening of asthma within 4 weeks of screening visit

• lung disease other than asthma

• significant medical comorbidity

• current smoker or ex-smoker with significant smoking history

• currently pregnant or breastfeeding

Related Conditions & MeSH terms

• Asthma
• Respiratory Aspiration

Intervention

Procedure:
• Deep inhalation technique
Use of deep inhalations for administration of inhalant
• Tidal breathing technique
Use of tidal breathing for administration of inhalant

Drug:
• Methacholine
Methacholine direct bronchoconstrictor used for bronchoprovocation challenge
• Mannitol
Mannitol indirect bronchoconstrictor used for bronchoprovocation challenge

Locations

Country	Name	City	State
Canada	Asthma Research Lab - University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of deep inhalation (versus tidal breathing) on mannitol provocative dose causing a 15% fall in forced expiratory volume in one second (FEV1)	Shift in mannitol provocative dose causing a 15% fall in forced expiratory volume	24 hours between mannitol challenges
Secondary	Effect of airway inflammation on methacholine and mannitol challenge results-fractional exhaled nitric oxide	Collection of fractional exhaled nitric oxide at screening - analysis of resulting measurement indicative of degree of baseline airway inflammation	up to 2 weeks, from baseline to end of study
Secondary	Effect of airway inflammation on methacholine and mannitol challenge results-sputum	Collection of sputum at screening - analysis for differential cell counts indicative of degree of baseline airway inflammation	up to 2 weeks, from baseline to end of study
Secondary	Effect of deep inhalation (versus tidal breathing) on methacholine provocative	Shift in methacholine provocative dose causing a 20% fall in forced expiratory volume	24 hours between methacholine challenges