Back to resultsDetermining Baseline Respiratory Duty Cycles in Subjects With and Without Airway Hyperresponsiveness
Primary Purpose
Airway Hyper Responsiveness
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Volumetric methacholine challenge unmodified
Modified volumetric methacholine challenge
Sponsored by
About this trial
This is an interventional treatment trial for Airway Hyper Responsiveness
Eligibility Criteria
Inclusion Criteria:
- Must be 18 years of age or older
- Participants with airway hyper-responsiveness must have a positive methacholine challenge
- Forced expiratory volume (FEV1) of at least 65% of predicted (based on age, height, and gender)
- Participants without airway hyper-responsiveness must have a negative methacholine challenge
- All participants must avoid strenuous exercise on test days
- No short-acting beta-2 agonist use within 6 hours of study visit
Exclusion Criteria:
- Participants without known airway hyper-responsiveness cannot have a current or historical respiratory condition (e.g. asthma, allergic rhinitis)
- Participants cannot be taking long-acting bronchodilators
- Participants cannot be pregnant or lactating
- Participants cannot have cardiovascular problems
Sites / Locations
- Asthma Research Lab - University of Saskatchewan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Volumetric methacholine challenge
Methacholine challenge with spirometer
Arm Description
Methacholine challenge performed per the volumetric method using an Aerogen Solo vibrating mesh nebulizer
Methacholine challenge performed per the volumetric method using an Aerogen Solo vibrating mesh nebulizer fitted with an ultrasonic spirometer
Outcomes
Primary Outcome Measures
Average inspiratory duty cycle in subjects with airway hyper-responsiveness measured using ultrasonic spirometer and tidal breathing
The inspiratory duty cycles measured for each participant (in duplicate over at least 24 hours) will be averaged for all participants with airway hyper-responsiveness and for all participants without airway-hyperresponsiveness
Average inspiratory duty cycle in subjects without airway hyper-responsiveness
The inspiratory duty cycles measured for each participant (in duplicate over at least 24 hours) will be averaged for all participants without airway hyper-responsiveness
Secondary Outcome Measures
Within-subject variability in inspiratory duty cycle measured using ultrasonic spirometer and tidal breathing during room air inhalation
Repeat measurements of inspiratory duty cycle during tidal breathing of room air collected at least 24 hours apart
Between-subject variability within subject group (i.e. airway hyper-responsiveness group)
Investigation of whether subjects differ in their inspiratory duty cycles (within their respective study group)
Variability in inspiratory duty cycle within subjects when inhaling room air versus an aerosol while using tidal breathing through an ultrasonic spirometer
Investigation of whether participants differ in their inspiratory duty cycle when inhaling room air versus a saline vapor (i.e. does an aerosol influence people's breathing pattern)
Within-subject variability in provocative dose of methacholine causing a 20% fall in forced expiratory volume (PD20) between repeat methacholine challenges
Repeat PD20 measures collected for each participant will be compared to determine if there is any significant within-subject variability in PD20
Variability in inspiratory duty cycle with progressive airway constriction induced through methacholine challenge testing
The inspiratory duty cycle in each subject will be measured throughout a methacholine challenge during each inhalation period, which will allow for determination of whether the inspiratory duty cycle changes with the progressive airway constriction (or lack thereof) induced through methacholine challenge testing
Variability in in inspiratory duty cycle between airway hyper-responsiveness group and group without airway-hyperresponsiveness
Analysis of variance to determine whether subjects differ in their inspiratory duty cycles based on their status as having or as not having airway-hyperresponsiveness
Within-subject variability in inspiratory duty cycle measured using ultrasonic spirometer and tidal breathing during saline inhalation
Repeat measurements of inspiratory duty cycle during tidal breathing of nebulized saline collected at least 24 hours apart
Between-subject variability within subject group (no airway hyper-responsiveness group)
Investigation of whether subjects differ in their inspiratory duty cycles (within their respective study group)
Full Information
NCT ID
NCT04001465
First Posted
June 11, 2019
Last Updated
March 25, 2020
Sponsor
University of Saskatchewan
1. Study Identification
Unique Protocol Identification Number
NCT04001465
Brief Title
Determining Baseline Respiratory Duty Cycles in Subjects With and Without Airway Hyperresponsiveness
Official Title
Determining Baseline Respiratory Duty Cycles in Subjects With and Without Airway Hyperresponsiveness
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 14, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study investigates the inspiratory duty cycle in subjects with and without airway hyper-responsiveness both at rest and during a bronchoprovocation challenge. The primary goal is to determine an average inspiratory duty cycle for standard use in the calculation of bronchoprovocation test results.
Detailed Description
At least fifteen subjects with airway hyper-responsiveness and fifteen without airway hyper-responsiveness will be recruited to participate in this randomized, crossover study. Subjects will complete 2 methacholine challenges at least 24 hours apart. One methacholine challenge will entail the volumetric method using a vibrating mesh nebulizer. The second methacholine challenge will be performed identically except that the nebulizer will be fitted onto an ultrasonic nebulizer so as to measure the inspiratory duty cycle throughout the bronchoprovocation challenge.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Hyper Responsiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Volumetric methacholine challenge
Arm Type
Active Comparator
Arm Description
Methacholine challenge performed per the volumetric method using an Aerogen Solo vibrating mesh nebulizer
Arm Title
Methacholine challenge with spirometer
Arm Type
Active Comparator
Arm Description
Methacholine challenge performed per the volumetric method using an Aerogen Solo vibrating mesh nebulizer fitted with an ultrasonic spirometer
Intervention Type
Procedure
Intervention Name(s)
Volumetric methacholine challenge unmodified
Intervention Description
Bronchoprovocation challenge performed per volumetric method
Intervention Type
Procedure
Intervention Name(s)
Modified volumetric methacholine challenge
Intervention Description
Bronchoprovocation challenge performed per volumetric method modified to include use of ultrasonic spirometer fitted with vibrating mesh nebulizer
Primary Outcome Measure Information:
Title
Average inspiratory duty cycle in subjects with airway hyper-responsiveness measured using ultrasonic spirometer and tidal breathing
Description
The inspiratory duty cycles measured for each participant (in duplicate over at least 24 hours) will be averaged for all participants with airway hyper-responsiveness and for all participants without airway-hyperresponsiveness
Time Frame
24 hours
Title
Average inspiratory duty cycle in subjects without airway hyper-responsiveness
Description
The inspiratory duty cycles measured for each participant (in duplicate over at least 24 hours) will be averaged for all participants without airway hyper-responsiveness
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Within-subject variability in inspiratory duty cycle measured using ultrasonic spirometer and tidal breathing during room air inhalation
Description
Repeat measurements of inspiratory duty cycle during tidal breathing of room air collected at least 24 hours apart
Time Frame
24 hours
Title
Between-subject variability within subject group (i.e. airway hyper-responsiveness group)
Description
Investigation of whether subjects differ in their inspiratory duty cycles (within their respective study group)
Time Frame
1 hour
Title
Variability in inspiratory duty cycle within subjects when inhaling room air versus an aerosol while using tidal breathing through an ultrasonic spirometer
Description
Investigation of whether participants differ in their inspiratory duty cycle when inhaling room air versus a saline vapor (i.e. does an aerosol influence people's breathing pattern)
Time Frame
1 hour
Title
Within-subject variability in provocative dose of methacholine causing a 20% fall in forced expiratory volume (PD20) between repeat methacholine challenges
Description
Repeat PD20 measures collected for each participant will be compared to determine if there is any significant within-subject variability in PD20
Time Frame
24 hours
Title
Variability in inspiratory duty cycle with progressive airway constriction induced through methacholine challenge testing
Description
The inspiratory duty cycle in each subject will be measured throughout a methacholine challenge during each inhalation period, which will allow for determination of whether the inspiratory duty cycle changes with the progressive airway constriction (or lack thereof) induced through methacholine challenge testing
Time Frame
24 hours
Title
Variability in in inspiratory duty cycle between airway hyper-responsiveness group and group without airway-hyperresponsiveness
Description
Analysis of variance to determine whether subjects differ in their inspiratory duty cycles based on their status as having or as not having airway-hyperresponsiveness
Time Frame
1 hour
Title
Within-subject variability in inspiratory duty cycle measured using ultrasonic spirometer and tidal breathing during saline inhalation
Description
Repeat measurements of inspiratory duty cycle during tidal breathing of nebulized saline collected at least 24 hours apart
Time Frame
24 hours
Title
Between-subject variability within subject group (no airway hyper-responsiveness group)
Description
Investigation of whether subjects differ in their inspiratory duty cycles (within their respective study group)
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must be 18 years of age or older
Participants with airway hyper-responsiveness must have a positive methacholine challenge
Forced expiratory volume (FEV1) of at least 65% of predicted (based on age, height, and gender)
Participants without airway hyper-responsiveness must have a negative methacholine challenge
All participants must avoid strenuous exercise on test days
No short-acting beta-2 agonist use within 6 hours of study visit
Exclusion Criteria:
Participants without known airway hyper-responsiveness cannot have a current or historical respiratory condition (e.g. asthma, allergic rhinitis)
Participants cannot be taking long-acting bronchodilators
Participants cannot be pregnant or lactating
Participants cannot have cardiovascular problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Don Cockcroft, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asthma Research Lab - University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Determining Baseline Respiratory Duty Cycles in Subjects With and Without Airway Hyperresponsiveness
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