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

October 17, 2012 updated by: Guy Steuer

Double Blind Placebo Controlled Trial Checking the Safety and Efficacy of the Inspiromatic Inhaler in Comparison to the Aerolizer Inhaler When Delivering Formoterol

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Petach - Tikva, Israel
        • Schneider Children Hospital
        • Contact:
        • Principal Investigator:
          • Guy Steuer, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Foradil Inhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEV1
Time Frame: We will measure FEV1 post treatment (15 min, 30 min, 60 min)
Change in FEV1 from base line
We will measure FEV1 post treatment (15 min, 30 min, 60 min)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital signs
Time Frame: Pre treatment and than 15 minutes post treatment
Change in heart rate, blood pressure
Pre treatment and than 15 minutes post treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic absorption
Time Frame: 0 and 15 minutes post inhaltion
K concentration, Glucose levels and drug level
0 and 15 minutes post inhaltion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy Steuer

Collaborators

Schneider Children's Medical Center, Israel
Inspiromedical Inc

Investigators

  • Principal Investigator: Guy Steuer, M.D., Schneider Children Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

September 22, 2012

First Submitted That Met QC Criteria

October 17, 2012

First Posted (Estimate)

October 22, 2012

Study Record Updates

Last Update Posted (Estimate)

October 22, 2012

Last Update Submitted That Met QC Criteria

October 17, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0401-11-RMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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