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

NCT ID: NCT04001465

Last Updated: 2020-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-14
• Study Completion Date: 2019-06-30

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.

Conditions

Airway Hyper Responsiveness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Volumetric methacholine challenge

Methacholine challenge performed per the volumetric method using an Aerogen Solo vibrating mesh nebulizer

Group Type: ACTIVE_COMPARATOR

Volumetric methacholine challenge unmodified

Intervention Type: PROCEDURE

Bronchoprovocation challenge performed per volumetric method

Methacholine challenge with spirometer

Methacholine challenge performed per the volumetric method using an Aerogen Solo vibrating mesh nebulizer fitted with an ultrasonic spirometer

Group Type: ACTIVE_COMPARATOR

Modified volumetric methacholine challenge

Intervention Type: PROCEDURE

Bronchoprovocation challenge performed per volumetric method modified to include use of ultrasonic spirometer fitted with vibrating mesh nebulizer

Interventions

Volumetric methacholine challenge unmodified

Bronchoprovocation challenge performed per volumetric method

Intervention Type: PROCEDURE

Modified volumetric methacholine challenge

Bronchoprovocation challenge performed per volumetric method modified to include use of ultrasonic spirometer fitted with vibrating mesh nebulizer

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Don Cockcroft

Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Don Cockcroft, MD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

Asthma Research Lab - University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

TiTtot-2019

Identifier Type: -

Identifier Source: org_study_id