Safety and Efficacy of the Inspiromatic Inhaler in Comparison to the Aerolizer Inhaler When Delivering Formoterol
NCT ID: NCT01711086
Last Updated: 2012-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2012-10-31
2012-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Inspiromatic followed by Aerolizer
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.
Inspiromatic followed by Aerolizer
Participants will receive Formoterol (Foradil) 12mcg via the Inspiromatic dry powder inhaler while performing lung function instead of getting it via the Foradil Aerolizer
Aerolizer followed by Inspiromatic
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.
Aerolizer Followed by Inspiromatic
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
Interventions
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Aerolizer Followed by Inspiromatic
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
Inspiromatic followed by Aerolizer
Participants will receive Formoterol (Foradil) 12mcg via the Inspiromatic dry powder inhaler while performing lung function instead of getting it via the Foradil Aerolizer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 50\<FEV1\<80
* Can perform Spirometry
Exclusion Criteria
* Pregnancy
* Milk Allergy
* Other lung disease
* Prior familiarity with Aerolizer
8 Years
18 Years
ALL
No
Sponsors
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Schneider Children's Medical Center, Israel
OTHER
Inspiromedical Inc
UNKNOWN
Guy Steuer
OTHER
Responsible Party
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Guy Steuer
Guy Steuer, M.D.
Principal Investigators
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Guy Steuer, M.D.
Role: PRINCIPAL_INVESTIGATOR
Schneider Children Hospital
Locations
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Schneider Children Hospital
Petah Tikva, , Israel
Countries
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Central Contacts
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Facility Contacts
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Guy Steuer, M.D.
Role: primary
Other Identifiers
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0401-11-RMC
Identifier Type: -
Identifier Source: org_study_id