Determining Baseline Respiratory Duty Cycles in Subjects With and Without Airway Hyperresponsiveness

March 25, 2020 updated by: Don Cockcroft, University of Saskatchewan
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Asthma Research Lab - University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Volumetric methacholine challenge
Methacholine challenge performed per the volumetric method using an Aerogen Solo vibrating mesh nebulizer
Procedure: Volumetric methacholine challenge unmodified
Bronchoprovocation challenge performed per volumetric method
ACTIVE_COMPARATOR: Methacholine challenge with spirometer
Methacholine challenge performed per the volumetric method using an Aerogen Solo vibrating mesh nebulizer fitted with an ultrasonic spirometer
Procedure: Modified volumetric methacholine challenge
Bronchoprovocation challenge performed per volumetric method modified to include use of ultrasonic spirometer fitted with vibrating mesh nebulizer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
24 hours
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
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Within-subject variability in inspiratory duty cycle measured using ultrasonic spirometer and tidal breathing during room air inhalation
Time Frame: 24 hours
Repeat measurements of inspiratory duty cycle during tidal breathing of room air collected at least 24 hours apart
24 hours
Between-subject variability within subject group (i.e. airway hyper-responsiveness group)
Time Frame: 1 hour
Investigation of whether subjects differ in their inspiratory duty cycles (within their respective study group)
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
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)
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
Repeat PD20 measures collected for each participant will be compared to determine if there is any significant within-subject variability in PD20
24 hours
Variability in inspiratory duty cycle with progressive airway constriction induced through methacholine challenge testing
Time Frame: 24 hours
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
24 hours
Variability in in inspiratory duty cycle between airway hyper-responsiveness group and group without airway-hyperresponsiveness
Time Frame: 1 hour
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
1 hour
Within-subject variability in inspiratory duty cycle measured using ultrasonic spirometer and tidal breathing during saline inhalation
Time Frame: 24 hours
Repeat measurements of inspiratory duty cycle during tidal breathing of nebulized saline collected at least 24 hours apart
24 hours
Between-subject variability within subject group (no airway hyper-responsiveness group)
Time Frame: 1 hour
Investigation of whether subjects differ in their inspiratory duty cycles (within their respective study group)
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Saskatchewan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 14, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TiTtot-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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