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Trial record 1 of 1 for:    Inspiromatic
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Safety and Efficacy of the Inspiromatic Inhaler in Comparison to the Aerolizer Inhaler When Delivering Formoterol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01711086
Recruitment Status : Unknown
Verified October 2012 by Guy Steuer, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 22, 2012
Last Update Posted : October 22, 2012
Sponsor:
Collaborators:
Schneider Children's Medical Center, Israel
Inspiromedical Inc
Information provided by (Responsible Party):
Guy Steuer, Rabin Medical Center

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.


Condition or disease Intervention/treatment Phase
Asthma Device: Aerolizer Followed by Inspiromatic Device: Inspiromatic followed by Aerolizer Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : October 2012
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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 Name: 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 Name: Foradil Inhaler




Primary Outcome Measures :
  1. FEV1 [ Time Frame: We will measure FEV1 post treatment (15 min, 30 min, 60 min) ]
    Change in FEV1 from base line


Secondary Outcome Measures :
  1. Vital signs [ Time Frame: Pre treatment and than 15 minutes post treatment ]
    Change in heart rate, blood pressure


Other Outcome Measures:
  1. Systemic absorption [ Time Frame: 0 and 15 minutes post inhaltion ]
    K concentration, Glucose levels and drug level



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711086


Contacts
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Contact: Guy Steuer, M.D. +972524249925 kids.lung@gmail.com
Contact: Hanna Blau, M.D. +97239253654 hanhblau@post.tau.ac.il

Locations
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Israel
Schneider Children Hospital
Petach - Tikva, Israel
Contact: Guy Steuer, M.D.    +972524249925    kids.lung@gmail.com   
Principal Investigator: Guy Steuer, M.D.         
Sponsors and Collaborators
Guy Steuer
Schneider Children's Medical Center, Israel
Inspiromedical Inc
Investigators
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Principal Investigator: Guy Steuer, M.D. Schneider Children Hospital
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Responsible Party: Guy Steuer, Guy Steuer, M.D., Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01711086    
Other Study ID Numbers: 0401-11-RMC
First Posted: October 22, 2012    Key Record Dates
Last Update Posted: October 22, 2012
Last Verified: October 2012
Keywords provided by Guy Steuer, Rabin Medical Center:
asthma
dry powder inhaler
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action