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
Overview
- Phase
- Phase 2
- Intervention
- 80/2.25 μg Symbicort pMDI
- Conditions
- Asthma
- Sponsor
- AstraZeneca
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Average 12 Hour Forced Expiratory Volume in 1 Second (FEV1)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
BUD 160/FM 2.25
2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI × 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
Intervention: 80/2.25 μg Symbicort pMDI
BUD 160/FM 2.25
2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI × 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
Intervention: 40 μg budesonide HFA pMDI
BUD 160/FM 4.5
placebo HFA pMDI × 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI × 2 inhalations)
Intervention: 80/2.25 μg Symbicort pMDI
BUD 160/FM 4.5
placebo HFA pMDI × 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI × 2 inhalations)
Intervention: placebo HFA pMDI
BUD 160/FM 9.0
placebo HFA pMDI × 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI × 2 inhalations)
Intervention: 80/4.5 μg Symbicort pMDI
BUD 160/FM 9.0
placebo HFA pMDI × 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI × 2 inhalations)
Intervention: placebo HFA pMDI
BUD 160
placebo HFA pMDI × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
Intervention: 40 μg budesonide HFA pMDI
BUD 160
placebo HFA pMDI × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
Intervention: placebo HFA pMDI
BUD 160/Foradil 12.0
Foradil Aerolizer 12 μg × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
Intervention: Foradil Aerolizer 12 μg
BUD 160/Foradil 12.0
Foradil Aerolizer 12 μg × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
Intervention: 40 μg budesonide HFA pMDI
Outcomes
Primary Outcomes
Average 12 Hour Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose
Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 was obtained from the full expiratory flow-volume-time curve. FEV1 was measured at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes post administration of randomized study medication. Twelve-hour serial FEV1 was calculated through an AUC determination and then divided by time, so that the final value is expressed in liters. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.
Secondary Outcomes
- Maximal FEV1 During the 12-hour Study Period(at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose)
- FEV1 at 12 Hours After Study Medication Inhalation(12 hours after dosing)
- Urinary Excretion of Formoterol During the 12 Hours Following Inhalation of Study Drug(0 to 12 hours)