Airway Hyper ResponsivenessNCT04001465
Determining Baseline Respiratory Duty Cycles in Subjects With and Without Airway Hyperresponsiveness
A study testing Volumetric methacholine challenge unmodified and Modified volumetric methacholine challenge in people with Airway Hyper Responsiveness, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Airway Hyper Responsiveness
- What is being tested?
- Volumetric methacholine challenge unmodified and Modified volumetric methacholine challenge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 14 May 2019to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Asthma Research Lab - University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
About this study
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.
Read the 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.
- Conditions
- Airway Hyper Responsiveness
- Being tested
- Volumetric methacholine challenge unmodified, Modified volumetric methacholine challenge
- Medical subject headings
- Respiratory Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volumetric methacholine challenge unmodifiedProcedure or surgery
Bronchoprovocation challenge performed per volumetric method
Modified volumetric methacholine challengeProcedure or surgery
Bronchoprovocation challenge performed per volumetric method modified to include use of ultrasonic spirometer fitted with vibrating mesh nebulizer
| Study group | Role | What they receive |
|---|---|---|
| Volumetric methacholine challenge | Active comparator | Methacholine challenge performed per the volumetric method using an Aerogen Solo vibrating mesh nebulizer Receives: Procedure: Volumetric methacholine challenge unmodified |
| Methacholine challenge with spirometer | Active comparator | Methacholine challenge performed per the volumetric method using an Aerogen Solo vibrating mesh nebulizer fitted with an ultrasonic spirometer Receives: Procedure: Modified volumetric methacholine challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
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
Measured: 24 hours
Secondary outcomes (8)
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
Measured: 24 hours
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)
Measured: 1 hour
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)
Measured: 1 hour
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
Measured: 24 hours
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
Measured: 24 hours
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
Measured: 1 hour
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
Measured: 24 hours
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)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start14 May 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Hyper ResponsivenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Don Cockcroft, University of Saskatchewan
- Investigators
- Don Cockcroft, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001465
- Sponsor's protocol ID
- TiTtot-2019
- Status last verified
- Mar 2020
- First submitted
- 11 Jun 2019
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Baseline Respiratory Duty Cycles in Subjects With and Without Airway Hyperresponsiveness
- ClinicalTrials.gov ID
- NCT04001465
- Acronym / sponsor ID
- TiTtot-2019
- Conditions
- Airway Hyper Responsiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 14 May 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volumetric methacholine challenge | Active comparator | Procedure: Volumetric methacholine challenge unmodifiedMethacholine challenge performed per the volumetric method using an Aerogen Solo vibrating mesh nebulizer |
| Methacholine challenge with spirometer | Active comparator | Procedure: Modified volumetric methacholine challengeMethacholine challenge performed per the volumetric method using an Aerogen Solo vibrating mesh nebulizer fitted with an ultrasonic spirometer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volumetric methacholine challenge unmodifiedBronchoprovocation challenge performed per volumetric method | Procedure or surgery | Volumetric methacholine challenge |
| Modified volumetric methacholine challengeBronchoprovocation challenge performed per volumetric method modified to include use of ultrasonic spirometer fitted with vibrating mesh nebulizer | Procedure or surgery | Methacholine challenge with spirometer |
Primary outcome
Average inspiratory duty cycle in subjects with airway hyper-responsiveness measured using ultrasonic spirometer and tidal breathing
Time frame: 24 hours
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
Time frame: 24 hours
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
8 secondary outcomes
Within-subject variability in inspiratory duty cycle measured using ultrasonic spirometer and tidal breathing during room air inhalation
Time frame: 24 hours
Between-subject variability within subject group (i.e. airway hyper-responsiveness group)
Time frame: 1 hour
Variability in inspiratory duty cycle within subjects when inhaling room air versus an aerosol while using tidal breathing through an ultrasonic spirometer
Time frame: 1 hour
Within-subject variability in provocative dose of methacholine causing a 20% fall in forced expiratory volume (PD20) between repeat methacholine challenges
Time frame: 24 hours
Variability in inspiratory duty cycle with progressive airway constriction induced through methacholine challenge testing
Time frame: 24 hours
Variability in in inspiratory duty cycle between airway hyper-responsiveness group and group without airway-hyperresponsiveness
Time frame: 1 hour
Within-subject variability in inspiratory duty cycle measured using ultrasonic spirometer and tidal breathing during saline inhalation
Time frame: 24 hours
Between-subject variability within subject group (no airway hyper-responsiveness group)
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Don Cockcroft, MD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volumetric methacholine challenge unmodified and Modified volumetric methacholine challenge in people with Airway Hyper Responsiveness, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average inspiratory duty cycle in subjects with airway hyper-responsiveness measured using ultrasonic spirometer and tidal breathing (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.