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

Primary Purpose

Asthma

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Aerolizer Followed by Inspiromatic
Inspiromatic followed by Aerolizer
Sponsored by
Guy Steuer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, dry powder inhaler

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Schneider Children Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Inspiromatic followed by Aerolizer

Aerolizer followed by Inspiromatic

Arm 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.

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.

Outcomes

Primary Outcome Measures

FEV1
Change in FEV1 from base line

Secondary Outcome Measures

Vital signs
Change in heart rate, blood pressure

Full Information

First Posted
September 22, 2012
Last Updated
October 17, 2012
Sponsor
Guy Steuer
Collaborators
Schneider Children's Medical Center, Israel, Inspiromedical Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01711086
Brief Title
Safety and Efficacy of the Inspiromatic Inhaler in Comparison to the Aerolizer Inhaler When Delivering Formoterol
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 Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Guy Steuer
Collaborators
Schneider Children's Medical Center, Israel, Inspiromedical Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, dry powder inhaler

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inspiromatic followed by Aerolizer
Arm Type
Active Comparator
Arm 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.
Arm Title
Aerolizer followed by Inspiromatic
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Aerolizer Followed by Inspiromatic
Other Intervention Name(s)
Foradil Inhaler
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Inspiromatic followed by Aerolizer
Other Intervention Name(s)
Inspiromatic dry powder experimental inhaler
Intervention Description
Participants will receive Formoterol (Foradil) 12mcg via the Inspiromatic dry powder inhaler while performing lung function instead of getting it via the Foradil Aerolizer
Primary Outcome Measure Information:
Title
FEV1
Description
Change in FEV1 from base line
Time Frame
We will measure FEV1 post treatment (15 min, 30 min, 60 min)
Secondary Outcome Measure Information:
Title
Vital signs
Description
Change in heart rate, blood pressure
Time Frame
Pre treatment and than 15 minutes post treatment
Other Pre-specified Outcome Measures:
Title
Systemic absorption
Description
K concentration, Glucose levels and drug level
Time Frame
0 and 15 minutes post inhaltion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guy Steuer, M.D.
Phone
+972524249925
Email
kids.lung@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hanna Blau, M.D.
Phone
+97239253654
Email
hanhblau@post.tau.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Steuer, M.D.
Organizational Affiliation
Schneider Children Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider Children Hospital
City
Petach - Tikva
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy Steuer, M.D.
Phone
+972524249925
Email
kids.lung@gmail.com
First Name & Middle Initial & Last Name & Degree
Guy Steuer, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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