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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

Tracking Information
First Submitted Date  ICMJE March 29, 2018
First Posted Date  ICMJE April 23, 2018
Last Update Posted Date May 15, 2019
Actual Study Start Date  ICMJE June 1, 2018
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03505489 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Deep Inhalation on Mannitol Responsiveness
Official Title  ICMJE The Effect of Deep Inhalation on Mannitol Responsiveness
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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
    Other Name: Provocholine
  • Drug: Mannitol
    Mannitol indirect bronchoconstrictor used for bronchoprovocation challenge
    Other Name: Aridol
Study Arms  ICMJE
  • Experimental: Mannitol challenge
    Mannitol challenge performed per standard mannitol challenge procedure with deep inhalation technique
    Interventions:
    • Procedure: Deep inhalation technique
    • Drug: Mannitol
  • Experimental: Mannitol challenge w/ TBI
    Mannitol challenge performed per standard mannitol challenge procedure except with tidal breathing technique
    Interventions:
    • Procedure: Tidal breathing technique
    • Drug: Mannitol
  • Experimental: Methacholine challenge w/ DI
    Methacholine challenge performed per standard 2-minute tidal breathing challenge procedure except with deep inhalation technique
    Interventions:
    • Procedure: Deep inhalation technique
    • Drug: Methacholine
  • Experimental: Methacholine challenge
    Methacholine challenge performed per standard 2-minute tidal breathing challenge procedure (tidal breathing technique)
    Interventions:
    • Procedure: Tidal breathing technique
    • Drug: Methacholine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2019)
26
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2018)
20
Actual Study Completion Date  ICMJE April 30, 2019
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03505489
Other Study ID Numbers  ICMJE MAN-2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Don Cockcroft, University of Saskatchewan
Study Sponsor  ICMJE University of Saskatchewan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr. Don Cockcroft, MD University of Saskatchewan
PRS Account University of Saskatchewan
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP