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

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

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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