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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01711086
• Other study ID #: 0401-11-RMC
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: September 22, 2012
• Last updated: October 17, 2012
• Start date: October 2012
• Est. completion date: December 2012

Study information

• Verified date: October 2012
• Source: Rabin Medical Center
• Contact: Guy Steuer, M.D.
• Phone: +972524249925
• Email: kids.lung[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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
• 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

Locations

Country	Name	City	State
Israel	Schneider Children Hospital	Petach - Tikva

Sponsors (3)

Lead Sponsor	Collaborator
Guy Steuer	Inspiromedical Inc, Schneider Children's Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Systemic absorption	K concentration, Glucose levels and drug level	0 and 15 minutes post inhaltion	Yes
Primary	FEV1	Change in FEV1 from base line	We will measure FEV1 post treatment (15 min, 30 min, 60 min)	No
Secondary	Vital signs	Change in heart rate, blood pressure	Pre treatment and than 15 minutes post treatment	Yes