The Effect of Deep Inhalation on Mannitol Responsiveness

U

University of Saskatchewan

Status and phase

Completed
Phase 3

Conditions

Asthma

Treatments

Drug: Mannitol
Procedure: Tidal breathing technique
Procedure: Deep inhalation technique
Drug: Methacholine

Study type

Interventional

Funder types

Other

Identifiers

NCT03505489
MAN-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

26 participants in 4 patient groups

Mannitol challenge
Experimental group
Description:
Mannitol challenge performed per standard mannitol challenge procedure with deep inhalation technique
Treatment:
Procedure: Deep inhalation technique
Drug: Mannitol
Mannitol challenge w/ TBI
Experimental group
Description:
Mannitol challenge performed per standard mannitol challenge procedure except with tidal breathing technique
Treatment:
Procedure: Tidal breathing technique
Drug: Mannitol
Methacholine challenge w/ DI
Experimental group
Description:
Methacholine challenge performed per standard 2-minute tidal breathing challenge procedure except with deep inhalation technique
Treatment:
Drug: Methacholine
Procedure: Deep inhalation technique
Methacholine challenge
Experimental group
Description:
Methacholine challenge performed per standard 2-minute tidal breathing challenge procedure (tidal breathing technique)
Treatment:
Drug: Methacholine
Procedure: Tidal breathing technique

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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