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Completed

NCT Number: NCT04167280

Regular Use Effect of Inhaled Ipratropium Bromide on Airway Responsiveness to Methacholine in Well-controlled Asthma

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

About this study

This study is being conducted people with well controlled (mild) asthma to determine if ipratropium bromide taken three times daily for six days (i.e. 2 puffs in the morning, 2 puffs in the afternoon and 2 puffs in the evening) followed by a final dose on the morning of day 7 reduces the effectiveness of this medication on blocking the effect of methacholine challenge.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ipratropium Metered Dose Inhaler

Drug

MDI to deliver 20mcg per puff ipratropium bromide

Placebo Metered Dose Inhaler

Drug

matched MDI to deliver inactive drug

Primary outcomes

  1. Methacholine PD20

    Time frame: Pre treatment

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

  2. Methacholine PD20

    Time frame: Day 7 after starting treatment

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

  3. Methacholine PD20

    Time frame: 24 hours after last dose

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

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 18, 2019
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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