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The Effect of Deep Inhalation on Mannitol Responsiveness

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ClinicalTrials.gov Identifier: NCT03505489
Recruitment Status : Completed
First Posted : April 23, 2018
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Don Cockcroft, University of Saskatchewan

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.

Condition or disease Intervention/treatment Phase
Asthma Procedure: Deep inhalation technique Procedure: Tidal breathing technique Drug: Methacholine Drug: Mannitol Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Deep Inhalation on Mannitol Responsiveness
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


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 Name: Aridol

Experimental: Mannitol challenge w/ TBI
Mannitol challenge performed per standard mannitol challenge procedure except with tidal breathing technique
Procedure: Tidal breathing technique
Use of tidal breathing for administration of inhalant

Drug: Mannitol
Mannitol indirect bronchoconstrictor used for bronchoprovocation challenge
Other Name: Aridol

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 Name: 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 Name: Provocholine




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505489


Locations
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Canada, Saskatchewan
Asthma Research Lab - University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
Investigators
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Principal Investigator: Dr. Don Cockcroft, MD University of Saskatchewan

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Responsible Party: Don Cockcroft, Professor, College of Medicine, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT03505489     History of Changes
Other Study ID Numbers: MAN-2018
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Don Cockcroft, University of Saskatchewan:
Mannitol
Methacholine
Deep inhalation
Tidal breathing
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Mannitol
Methacholine Chloride
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action