Safety and Efficacy of the Inspiromatic Inhaler in Comparison to the Aerolizer Inhaler When Delivering Formoterol
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|ClinicalTrials.gov Identifier: NCT01711086|
Recruitment Status : Unknown
Verified October 2012 by Guy Steuer, Rabin Medical Center.
Recruitment status was: Not yet recruiting
First Posted : October 22, 2012
Last Update Posted : October 22, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Device: Aerolizer Followed by Inspiromatic Device: Inspiromatic followed by Aerolizer||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Double Blind Placebo Controlled Trial Checking the Safety and Efficacy of the Inspiromatic Inhaler in Comparison to the Aerolizer Inhaler When Delivering Formoterol|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||November 2012|
|Estimated Study Completion Date :||December 2012|
Active Comparator: 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.
Device: 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 Name: Inspiromatic dry powder experimental inhaler
Active Comparator: 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.
Device: 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
Other Name: Foradil Inhaler
- FEV1 [ Time Frame: We will measure FEV1 post treatment (15 min, 30 min, 60 min) ]Change in FEV1 from base line
- Vital signs [ Time Frame: Pre treatment and than 15 minutes post treatment ]Change in heart rate, blood pressure
- Systemic absorption [ Time Frame: 0 and 15 minutes post inhaltion ]K concentration, Glucose levels and drug level
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711086
|Contact: Guy Steuer, M.D.||+firstname.lastname@example.org|
|Contact: Hanna Blau, M.D.||+email@example.com|
|Schneider Children Hospital|
|Petach - Tikva, Israel|
|Contact: Guy Steuer, M.D. +972524249925 firstname.lastname@example.org|
|Principal Investigator: Guy Steuer, M.D.|
|Principal Investigator:||Guy Steuer, M.D.||Schneider Children Hospital|