MedTrace Logo

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

NCT01711086 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-10-22

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Schneider Children's Medical Center, Israel

    collaborator OTHER

  • Inspiromedical Inc

    collaborator UNKNOWN

  • Guy Steuer

    lead OTHER

Principal Investigators

  • Guy Steuer, M.D. · Schneider Children Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2012-11-30
Completion
2012-12-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01711086 on ClinicalTrials.gov