NCT01711086UnknownPhase 1
Double Blind Placebo Controlled Trial Checking the Safety and Efficacy of the Inspiromatic Inhaler in Comparison to the Aerolizer Inhaler When Delivering Formoterol
Conditions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Guy Steuer
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- FEV1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
FEV1
Time Frame: We will measure FEV1 post treatment (15 min, 30 min, 60 min)
Change in FEV1 from base line
Secondary Outcomes
- Vital signs(Pre treatment and than 15 minutes post treatment)
Investigators
Guy Steuer
Guy Steuer, M.D.
Rabin Medical Center
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Not Applicable
Baclofen/Diazepam Supps for Treatment of Pelvic Floor MyalgiaPelvic Floor DyssynergiaNCT03427216Dr. John A. Thiel Medical Professional Corporation60
Completed
Phase 2
Bilastine Updosing - Characterization of Underlying MechanismsCold Contact UrticariaNCT01271075Charite University, Berlin, Germany20
Completed
Phase 1
A Trial With Humanized TNFα Monoclonal Antibody Injection by Single Dose and Dose Escalation in Healthy SubjectsRheumatoid ArthritisNCT02460393Shenyang Sunshine Pharmaceutical Co., LTD.72
Completed
Phase 2
Topical Use of 20% Beta Caryophyllene Alone And In Combination With 0.025% Capsaicin for Pain Caused by Osteoarthritis Of The KneePainNCT03152578Panag Pharma Inc.56
Completed
Phase 1
Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy VolunteersQT/QTc Interval in Healthy VolunteersNCT03554304Wockhardt60