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Study population too narrow - unable to recruit any patients.
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| Name | Class |
|---|---|
| Children's Hospital of Eastern Ontario | OTHER |
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The investigators goal is to conduct a pilot randomized controlled trial (RCT) whose purpose is to determine the feasibility of a randomized trial designed to determine if either inhaled beclomethasone or a combination of inhaled beclomethasone/salbutamol (Clenil Compositum) are superior to placebo in treating pre-school aged children with an acute wheezing episode.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| beclomethasone | Active Comparator | beclomethasone dipropionate 250mcg per puff per puff (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days. Non-identifiable MDI prepared by Chiesi Farmaceutici Inc. |
|
| beclomethasone and salbutamol | Active Comparator | beclomethasone diprionate 250mcg and salbutamol 100mcg per puff (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days. Non-identifiable MDI prepared by Chiesi Farmaceutici Inc. |
|
| Placebo | Placebo Comparator | placebo (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days. Non-identifiable MDI prepared by Chiesi Farmaceutici Inc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beclomethasone | Drug |
|
| |
| Beclomethasone and Salbutamol |
| Measure | Description | Time Frame |
|---|---|---|
| Reduce unplanned-symptomatic visits to clinicians | After enrolment is complete |
| Measure | Description | Time Frame |
|---|---|---|
| Reduce the number of days with respiratory symptoms | Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days | |
| Reduce the need for rescue salbutamol use | Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital | Calgary | Alberta | T3B 6A8 | Canada |
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| ID | Term |
|---|---|
| D012135 | Respiratory Sounds |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| D000420 | Albuterol |
| D036501 | Metered Dose Inhalers |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Drug |
|
|
| Placebo | Drug |
|
| Aerochamber Max® | Device |
|
|
| Reduce hospitalization rates of target population | Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days |
| Reduce overall societal health care costs of target population | Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D009330 | Nebulizers and Vaporizers |
| D004864 | Equipment and Supplies |