NCT04167280

Brief Summary

Study is looking at the development of tolerance to methacholine following regular use of ipratropium bromide in mild asthmatics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4 asthma

Timeline
Completed

Started Nov 2019

Shorter than P25 for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

November 13, 2019

Last Update Submit

March 25, 2020

Conditions

Asthma

Keywords

ipratropium bromidemethacholine PD20tolerance

Outcome Measures

Primary Outcomes (3)

  • Methacholine PD20

    dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in one second)

    Pre treatment

  • Methacholine PD20

    dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in one second)

    Day 7 after starting treatment

  • Methacholine PD20

    dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in one second)

    24 hours after last dose

Study Arms (2)

Ipratropium bromide

ACTIVE COMPARATOR

20mcg bronchodilator inhaler

Drug: Ipratropium Metered Dose Inhaler

placebo

PLACEBO COMPARATOR

matching bronchodilator inhaler

Drug: placebo metered dose inhaler

Interventions

Ipratropium Metered Dose InhalerDRUG

MDI to deliver 20mcg per puff ipratropium bromide

Ipratropium bromide
placebo metered dose inhalerDRUG

matched MDI to deliver inactive drug

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • airway responsiveness to methacholine
  • adequate baseline lung function
  • no respiratory infection or exposure to stimuli that may alter response to methacholine within 4 weeks

You may not qualify if:

  • pregnancy
  • current smoker
  • requirement for medications other than salbutamol that will interfere with airway response to methacholine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Don Cockcroft, MD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 18, 2019

Study Start

November 5, 2019

Primary Completion

March 13, 2020

Study Completion

March 13, 2020

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)