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

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

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

Collaborators

Inclusion and exclusion criteria

Location

Research Site

KRUGERSDORP, Gauteng, South Africa

Location

Research Site

ALTOONA, PA, United States

Location

Research Site

BUDAPEST, Hungary

Location

Research Site

CAPE TOWN, SOUTH AFRICA, South Africa

Location

Research Site

CAPE TOWN, W CAPE, South Africa

Location

Research Site

CHARLESTON, SC, United States

Location

Research Site

CLAREMONT, W CAPE, South Africa

Location

Research Site

DUBLIN, Bulgaria

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

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=398&filename=CSR-D589GC00002.pdf
Download
CSR-D589GC00002.pdf
Download
D589GC00002 Clinical Study Protocol
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

Information.Center@AstraZeneca.com

Investigators

Principal Investigator

Lars-Goran Carlsson

AstraZeneca

A study in asthmatic children (6 to <12 yrs) comparing single doses of formoterol and Foradil® evaluating efficacy - CHASE 2

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=398&filename=CSR-D589GC00002.pdf

CSR-D589GC00002.pdf

D589GC00002 Clinical Study Protocol

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator