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

U

University of Saskatchewan

Status and phase

Completed
Phase 4

Conditions

Asthma

Treatments

Drug: Ipratropium Metered Dose Inhaler
Drug: placebo metered dose inhaler

Study type

Interventional

Funder types

Other

Identifiers

NCT04167280
Bio REB 1522

Details and patient eligibility

About

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

Full 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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

12 participants in 2 patient groups, including a placebo group

Ipratropium bromide
Active Comparator group
Description:
20mcg bronchodilator inhaler
Treatment:
Drug: Ipratropium Metered Dose Inhaler
placebo
Placebo Comparator group
Description:
matching bronchodilator inhaler
Treatment:
Drug: placebo metered dose inhaler

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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