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

NCT01711086 | Unknown Phase 1

• 1 other identifier: 0401-11-RMC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

asthma; dry powder inhaler

Outcome Measures

Primary Outcomes (1)

• FEV1

  Change in FEV1 from base line

  We will measure FEV1 post treatment (15 min, 30 min, 60 min)

Secondary Outcomes (1)

• Vital signs

  Pre treatment and than 15 minutes post treatment

Other Outcomes (1)

• Systemic absorption

  0 and 15 minutes post inhaltion

Study Arms (2)

Inspiromatic followed by Aerolizer

ACTIVE COMPARATOR

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

Aerolizer followed by Inspiromatic

ACTIVE COMPARATOR

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

Interventions

Aerolizer Followed by Inspiromatic DEVICE

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

Also known as: Foradil Inhaler

Aerolizer followed by Inspiromatic

Inspiromatic followed by Aerolizer DEVICE

Participants will receive Formoterol (Foradil) 12mcg via the Inspiromatic dry powder inhaler while performing lung function instead of getting it via the Foradil Aerolizer

Also known as: Inspiromatic dry powder experimental inhaler

Inspiromatic followed by Aerolizer

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children 8-18 years with Asthma
• \<FEV1\<80
• Can perform Spirometry

You may not qualify if:

• Poor cooperation
• Pregnancy
• Milk Allergy
• Other lung disease
• Prior familiarity with Aerolizer

Sponsors & Collaborators

• Guy Steuer: lead
• Schneider Children's Medical Center, Israel: collaborator
• Inspiromedical Inc: collaborator

Study Sites (1)

Schneider Children Hospital

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Guy Steuer, M.D.

  Schneider Children Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guy Steuer, M.D.

CONTACT

+972524249925; kids.lung@gmail.com

Hanna Blau, M.D.

CONTACT

+97239253654; hanhblau@post.tau.ac.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Guy Steuer, M.D.

Study Record Dates

• First Submitted: September 22, 2012
• First Posted: October 22, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 22, 2012

Record last verified: 2012-10

Locations

IL (1)