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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

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

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

NCT ID

NCT01711086

First Posted

September 22, 2012

Last Updated

October 17, 2012

Sponsor

Guy Steuer

Collaborators

Schneider Children's Medical Center, Israel, Inspiromedical Inc

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

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

Arm Title

Aerolizer followed by Inspiromatic

Arm Type

Active Comparator

Arm Description

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

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

kids.lung@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hanna Blau, M.D.

Phone

+97239253654

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

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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