The Effect of Deep Inhalation on Mannitol Responsiveness

NCT03505489 | Completed Phase 3

• 1 other identifier: MAN-2018
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

Mannitol; Methacholine; Deep inhalation; Tidal breathing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Effect of airway inflammation on methacholine and mannitol challenge results-fractional exhaled nitric oxide

  up to 2 weeks, from baseline to end of study

• Effect of airway inflammation on methacholine and mannitol challenge results-sputum

  up to 2 weeks, from baseline to end of study

• Effect of deep inhalation (versus tidal breathing) on methacholine provocative

  24 hours between methacholine challenges

Study Arms (4)

Mannitol challenge

EXPERIMENTAL

Mannitol challenge performed per standard mannitol challenge procedure with deep inhalation technique

Procedure: Deep inhalation technique; Drug: Mannitol

Mannitol challenge w/ TBI

EXPERIMENTAL

Mannitol challenge performed per standard mannitol challenge procedure except with tidal breathing technique

Procedure: Tidal breathing technique; Drug: Mannitol

Methacholine challenge w/ DI

EXPERIMENTAL

Methacholine challenge performed per standard 2-minute tidal breathing challenge procedure except with deep inhalation technique

Procedure: Deep inhalation technique; Drug: Methacholine

Methacholine challenge

EXPERIMENTAL

Methacholine challenge performed per standard 2-minute tidal breathing challenge procedure (tidal breathing technique)

Procedure: Tidal breathing technique; Drug: Methacholine

Interventions

Deep inhalation technique PROCEDURE

Use of deep inhalations for administration of inhalant

Mannitol challenge; Methacholine challenge w/ DI

Tidal breathing technique PROCEDURE

Use of tidal breathing for administration of inhalant

Mannitol challenge w/ TBI; Methacholine challenge

Methacholine DRUG

Methacholine direct bronchoconstrictor used for bronchoprovocation challenge

Also known as: Provocholine

Methacholine challenge; Methacholine challenge w/ DI

Mannitol DRUG

Mannitol indirect bronchoconstrictor used for bronchoprovocation challenge

Also known as: Aridol

Mannitol challenge; Mannitol challenge w/ TBI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Asthma Research Lab - University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (2)

• Blais CM, Davis BE, Cockcroft DW. The effect of deep inhalation on mannitol responsiveness. Clin Exp Allergy. 2020 Mar;50(3):308-314. doi: 10.1111/cea.13543. Epub 2019 Dec 14.

  PMID: 31785175 DERIVED

• Blais CM, Davis BE, Graham BL, Cockcroft DW. Respiratory Duty Cycles in Individuals With and Without Airway Hyperresponsiveness. Chest. 2020 Feb;157(2):356-362. doi: 10.1016/j.chest.2019.09.005. Epub 2019 Sep 19.

  PMID: 31542451 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Methacholine Chloride; Mannitol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methacholine Compounds; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Sugar Alcohols; Alcohols; Carbohydrates

Study Officials

• Dr. Don Cockcroft, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, College of Medicine

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 23, 2018
• Study Start: June 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: May 15, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)