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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04167280
• Other study ID #: Bio REB 1522
• Status: Completed
• Phase: Phase 4
• Start date: November 5, 2019
• Est. completion date: March 13, 2020

Study information

• Verified date: March 2020
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Ipratropium Metered Dose Inhaler
MDI to deliver 20mcg per puff ipratropium bromide
• placebo metered dose inhaler
matched MDI to deliver inactive drug

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Methacholine PD20	dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in one second)	Pre treatment
Primary	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
Primary	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