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Study is looking at the development of tolerance to methacholine following regular use of ipratropium bromide in mild asthmatics.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipratropium bromide | Active Comparator | 20mcg bronchodilator inhaler |
|
| placebo | Placebo Comparator | matching bronchodilator inhaler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipratropium Metered Dose Inhaler | Drug | MDI to deliver 20mcg per puff ipratropium bromide |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Don Cockcroft, MD | University of Saskatchewan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Saskatchewan | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| placebo metered dose inhaler | Drug | matched MDI to deliver inactive drug |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |