The Effect of Deep Inhalation on Mannitol Responsiveness

May 14, 2019 updated by: Don Cockcroft, University of Saskatchewan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Asthma Research Lab - University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mannitol challenge
Mannitol challenge performed per standard mannitol challenge procedure with deep inhalation technique
Procedure: Deep inhalation technique
Use of deep inhalations for administration of inhalant
Drug: Mannitol
Mannitol indirect bronchoconstrictor used for bronchoprovocation challenge
Other Names:
  • Aridol
EXPERIMENTAL: Mannitol challenge w/ TBI
Mannitol challenge performed per standard mannitol challenge procedure except with tidal breathing technique
Drug: Mannitol
Mannitol indirect bronchoconstrictor used for bronchoprovocation challenge
Other Names:
  • Aridol
Procedure: Tidal breathing technique
Use of tidal breathing for administration of inhalant
EXPERIMENTAL: Methacholine challenge w/ DI
Methacholine challenge performed per standard 2-minute tidal breathing challenge procedure except with deep inhalation technique
Procedure: Deep inhalation technique
Use of deep inhalations for administration of inhalant
Drug: Methacholine
Methacholine direct bronchoconstrictor used for bronchoprovocation challenge
Other Names:
  • Provocholine
EXPERIMENTAL: Methacholine challenge
Methacholine challenge performed per standard 2-minute tidal breathing challenge procedure (tidal breathing technique)
Procedure: Tidal breathing technique
Use of tidal breathing for administration of inhalant
Drug: Methacholine
Methacholine direct bronchoconstrictor used for bronchoprovocation challenge
Other Names:
  • Provocholine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of deep inhalation (versus tidal breathing) on mannitol provocative dose causing a 15% fall in forced expiratory volume in one second (FEV1)
Time Frame: 24 hours between mannitol challenges
Shift in mannitol provocative dose causing a 15% fall in forced expiratory volume
24 hours between mannitol challenges

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of airway inflammation on methacholine and mannitol challenge results-fractional exhaled nitric oxide
Time Frame: up to 2 weeks, from baseline to end of study
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
Effect of airway inflammation on methacholine and mannitol challenge results-sputum
Time Frame: up to 2 weeks, from baseline to end of study
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
Effect of deep inhalation (versus tidal breathing) on methacholine provocative
Time Frame: 24 hours between methacholine challenges
Shift in methacholine provocative dose causing a 20% fall in forced expiratory volume
24 hours between methacholine challenges

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2018

Primary Completion (ACTUAL)

April 30, 2019

Study Completion (ACTUAL)

April 30, 2019

Study Registration Dates

First Submitted

March 29, 2018

First Submitted That Met QC Criteria

April 20, 2018

First Posted (ACTUAL)

April 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAN-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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