Safety and Efficacy of the Inspiromatic Inhaler in Comparison to the Aerolizer Inhaler When Delivering Formoterol

Study Overview
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Brief Summary
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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.

Official Title
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Double Blind Placebo Controlled Trial Checking the Safety and Efficacy of the Inspiromatic Inhaler in Comparison to the Aerolizer Inhaler When Delivering Formoterol

Conditions
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Asthma

Intervention / Treatment
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* Device: Aerolizer Followed by Inspiromatic
* Device: Inspiromatic followed by Aerolizer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 8-18 years with Asthma 50<FEV1<80 Can perform Spirometry Exclusion Criteria: Poor cooperation Pregnancy Milk Allergy Other lung disease Prior familiarity with Aerolizer

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inspiromatic followed by Aerolizer<br>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. | Device: Inspiromatic followed by Aerolizer<br>* Participants will receive Formoterol (Foradil) 12mcg via the Inspiromatic dry powder inhaler while performing lung function instead of getting it via the Foradil Aerolizer<br>* Other names: Inspiromatic dry powder experimental inhaler;|
| Active Comparator: Aerolizer followed by Inspiromatic<br>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. | Device: Aerolizer Followed by Inspiromatic<br>* 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<br>* Other names: Foradil Inhaler;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 | Change in FEV1 from base line | We will measure FEV1 post treatment (15 min, 30 min, 60 min) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs | Change in heart rate, blood pressure | Pre treatment and than 15 minutes post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, dry powder inhaler