A study in asthmatic children (6 to <12 yrs) comparing single doses of formoterol and Foradil® evaluating efficacy - CHASE 2
Study identifier:D589GC00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 2, randomized, blinded, 5-period cross-over, placebo and active-controlled, multicenter, dose-finding study of single doses of formoterol 2.25 µg, 4.5 µg, and 9 µg delivered via Symbicort® pressurized metered-dose inhaler (pMDI) and Foradil® Aerolizer® 12 µg evaluating the bronchodilating effects and safety in children, ages 6 to <12 years, with asthma who are receiving background treatment with budesonide pMDI 160 ug bid
Medical condition
asthma
Phase
Phase 2
Healthy volunteers
No
Study drug
80/2.25 μg Symbicort pMDI, 80/4.5 μg Symbicort pMDI, Foradil Aerolizer 12 μg, 40 μg budesonide HFA pMDI, placebo HFA pMDI, 80 μg budesonide HFA pMDI
Sex
All
Actual Enrollment
54
Study type
Interventional
Age
6 Years - 11 Years
Date
Study Start Date: 01 Sept 2010
Primary Completion Date: 01 Dec 2011
Study Completion Date: 01 Dec 2011
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: BUD 160/FM 2.25 2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI × 1 inhalation) + 40 μg budesonide (BUD)hydrofluoroalkane (HFA) pMDI × 2 inhalations | Drug: 80/2.25 μg Symbicort pMDI inhalation Drug: 40 μg budesonide HFA pMDI inhalation |
| Experimental: BUD 160/FM 4.5 placebo HFA pMDI × 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI × 2 inhalations) | Drug: 80/2.25 μg Symbicort pMDI inhalation Drug: placebo HFA pMDI inhalation |
| Experimental: BUD 160/FM 9.0 placebo HFA pMDI × 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI × 2 inhalations) | Drug: 80/4.5 μg Symbicort pMDI inhalation Drug: placebo HFA pMDI inhalation |
| Placebo Comparator: BUD 160 placebo HFA pMDI × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations | Drug: 40 μg budesonide HFA pMDI inhalation Drug: placebo HFA pMDI inhalation Drug: 80 μg budesonide HFA pMDI inhalation |
| Active Comparator: BUD 160/Foradil 12.0 Foradil Aerolizer 12 μg × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations | Drug: Foradil Aerolizer 12 μg inhalation Drug: 40 μg budesonide HFA pMDI inhalation Drug: 80 μg budesonide HFA pMDI inhalation |
Contacts
Investigators
Principal Investigator
Lars-Goran Carlsson
AstraZeneca
