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| Name | Class |
|---|---|
| Schneider Children's Medical Center, Israel | OTHER |
| Inspiromedical Inc | UNKNOWN |
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Double-blind study, randomized, controlled, and crossover. Study recruited 30 volunteers with stable asthma aged 8-18 years. Participants will perform lung function as part of the routine follow-up then will receive a Foradil 12mcg either with an Aerolizer (a standard dry powder inhaler) or with the Inspiromatic (an active, breath synchronized innovative inhaler). 3-60 days later participants will receive the same drug through the other inhaler.
Pre and post treatment (15 min, 30 min, 60 min) Lung function results, drug levels in the blood, vital signs and side effects will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inspiromatic followed by Aerolizer | Active Comparator | volunteers will perform lung function pre and post Formoterol (a bronchodilator) inhalation. They will use either the Inspiromatic dry powder inhalers the delivery device. 3-60 days later participants will receive the same drug through the Aerolizer dry powder inhaler. |
|
| Aerolizer followed by Inspiromatic | Active Comparator | volunteers will perform lung function pre and post Formoterol (a bronchodilator) inhalation. They will use either the Aerolizer dry powder inhalers the delivery device. 3-60 days later participants will receive the same drug through the Inspiromatic dry powder inhaler. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerolizer Followed by Inspiromatic | Device | Participants will receive Formoterol (Foradil) 12mcg via the Foradil Aerolizer inhaler while performing lung function as part of the and not differ from other routine follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 | Change in FEV1 from base line | We will measure FEV1 post treatment (15 min, 30 min, 60 min) |
| Measure | Description | Time Frame |
|---|---|---|
| Vital signs | Change in heart rate, blood pressure | Pre treatment and than 15 minutes post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic absorption | K concentration, Glucose levels and drug level | 0 and 15 minutes post inhaltion |
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guy Steuer, M.D. | Contact | +972524249925 | kids.lung@gmail.com | |
| Hanna Blau, M.D. | Contact | +97239253654 | hanhblau@post.tau.ac.il |
| Name | Affiliation | Role |
|---|---|---|
| Guy Steuer, M.D. | Schneider Children Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Children Hospital | Petah Tikva | Israel |
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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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| Inspiromatic followed by Aerolizer | Device | Participants will receive Formoterol (Foradil) 12mcg via the Inspiromatic dry powder inhaler while performing lung function instead of getting it via the Foradil Aerolizer |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |