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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01711086

Enrollment

Registered

2012-10-22

Start date

2012-10-31

Completion date

2012-12-31

Last updated

2012-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

asthma, dry powder inhaler

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.

Interventions

DEVICEAerolizer 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

DEVICEInspiromatic 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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

8 Years to 18 Years

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

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

Israel

Contacts

Primary ContactGuy Steuer, M.D.

kids.lung@gmail.com+972524249925

Backup ContactHanna Blau, M.D.

hanhblau@post.tau.ac.il+97239253654

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026