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

Guy Steuer

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Asthma

Treatments: Device: Aerolizer Followed by Inspiromatic; Device: Inspiromatic followed by Aerolizer

Study type: Interventional

Funder types: Other

Identifiers

NCT01711086

0401-11-RMC

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Inspiromatic followed by Aerolizer

Active Comparator group

Description:

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.

Treatment:

Device: Inspiromatic followed by Aerolizer

Aerolizer followed by Inspiromatic

Active Comparator group

Description:

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.

Treatment:

Device: Aerolizer Followed by Inspiromatic