A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and Foradil® Evaluating Efficacy (CHASE 2)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: placebo HFA pMDI; Drug: 80/4.5 μg Symbicort pMDI; Drug: 40 μg budesonide HFA pMDI; Drug: Foradil Aerolizer 12 μg; Drug: 80/2.25 μg Symbicort pMDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT01136655

D589GC00002

Details and patient eligibility

About

This purpose of the study is to investigate the bronchodilating effects of 3 different dosages of formoterol given in combination with budesonide as Symbicort pMDI.

Full description

A Phase 2, randomized, blinded, 5-period cross-over, placebo and active controlled, multicenter, dose-finding study comparing single doses of formoterol 2.25 µg, 4.5 µg, and 9 µg delivered via Symbicort pMDI and Foradil® 12 µg evaluating the relative bronchodilating effects and safety in children.

Enrollment: 54 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a documented clinical diagnosis of asthma for at least 6 months prior to Visit 1
• Has a FEV1 measured at least 6 hours after the last dose of inhaled, short-acting β2-agonist (SABA) and at least 48 hours after the last dose of inhaled long-acting β2-agonist of =60% and =85% of predicted normal.
• Demonstrated reversibility of FEV1 of =15% from pre short acting beta agonist level within 15 to 30 minutes after administration of a standard dose of short acting beta agonist

Exclusion criteria

• Has been hospitalized for >24 hours at least once or required emergency treatment or urgent care visit more than once for an asthma-related condition during the 6 months prior to Visit 1
• Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 12 weeks prior to Visit 1.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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54 participants in 5 patient groups, including a placebo group

BUD 160/FM 2.25

Experimental group

Description:

2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI × 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations

Treatment:

Drug: 40 μg budesonide HFA pMDI

Drug: 80/2.25 μg Symbicort pMDI

BUD 160/FM 4.5

Experimental group

Description:

placebo HFA pMDI × 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI × 2 inhalations)

Treatment:

Drug: placebo HFA pMDI

Drug: 80/2.25 μg Symbicort pMDI

BUD 160/FM 9.0

Experimental group

Description:

placebo HFA pMDI × 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI × 2 inhalations)

Treatment:

Drug: placebo HFA pMDI

Drug: 80/4.5 μg Symbicort pMDI

BUD 160

Placebo Comparator group

Description:

placebo HFA pMDI × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations

Treatment:

Drug: placebo HFA pMDI

Drug: 40 μg budesonide HFA pMDI

BUD 160/Foradil 12.0

Active Comparator group

Description:

Foradil Aerolizer 12 μg × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations

Treatment:

Drug: Foradil Aerolizer 12 μg

Drug: 40 μg budesonide HFA pMDI