A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and Foradil® Evaluating Efficacy (CHASE 2)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01136655
First received: June 1, 2010
Last updated: September 25, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: formoterol/budesonide Drug: placebo/budesonide Drug: Foradil |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- AUC 0-12 for FEV1 [ Time Frame: At 5 clinic visits during approximately 5 weeks, spirometry will be peformed: before and at every hour for the first 4 hours and then every other hour up to 12 hours after drug inhalation ] [ Designated as safety issue: No ]
- AUC 0-12 for FEV1 [ Time Frame: At 5 clinic visits during approximately 5 weeks, spirometry will be peformed: before and at 3, 9, and 15 min after drug inhalation ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- FEV1 at 12 hours after study medication inhalation [ Time Frame: At 5 clinic visits during approximately 5 weeks, at 12 hours ] [ Designated as safety issue: No ]
- Max FEV1 [ Time Frame: At 5 clinic visits during approximately 5 weeks during 12 hours ] [ Designated as safety issue: No ]
- Urinary excretion of formoterol during 12 hours [ Time Frame: At 5 clinic visits during approximately 5 weeks collected during 12 hours ] [ Designated as safety issue: No ]
| Enrollment: | 54 |
| Study Start Date: | September 2010 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI ×1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations,
|
Drug: formoterol/budesonide
inhalation
|
|
Experimental: 2
placebo HFA pMDI × 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI × 2 inhalations)
|
Drug: formoterol/budesonide
inhalation
|
|
Experimental: 3
placebo HFA pMDI × 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI × 2 inhalations)
|
Drug: formoterol/budesonide
inhalation
Other Name: Symbicort pMDI
|
|
Placebo Comparator: 4
placebo HFA pMDI × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
|
Drug: placebo/budesonide
inhalation
|
|
Active Comparator: 5
Foradil 12 μg × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
|
Drug: Foradil
inhalation
Other Name: Foradil Aerolizer
|
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.
Eligibility| Ages Eligible for Study: | 6 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 �2-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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136655
Locations
| United States, California | |
| Research Site | |
| Huntington, California, United States | |
| Research Site | |
| Long Beach, California, United States | |
| Research Site | |
| Mission Viejo, California, United States | |
| Research Site | |
| Orange, California, United States | |
| Research Site | |
| Rolling Hills Estate, California, United States | |
| United States, Florida | |
| Research Site | |
| Sarasota, Florida, United States | |
| United States, Nebraska | |
| Research Site | |
| Omaha, Nebraska, United States | |
| United States, North Carolina | |
| Research Site | |
| Morrisville, North Carolina, United States | |
| Research Site | |
| Raleigh, North Carolina, United States | |
| United States, Oregon | |
| Research Site | |
| Eugene, Oregon, United States | |
| Research Site | |
| Lake Oswego, Oregon, United States | |
| Research Site | |
| Medford, Oregon, United States | |
| Research Site | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| Research Site | |
| Altoona, Pennsylvania, United States | |
| Research Site | |
| Upland, Pennsylvania, United States | |
| United States, South Carolina | |
| Research Site | |
| Charleston, South Carolina, United States | |
| United States, Texas | |
| Research Site | |
| El Paso, Texas, United States | |
| Research Site | |
| San Antonio, Texas, United States | |
| Research Site | |
| Waco, Texas, United States | |
| United States, Virginia | |
| Research Site | |
| Springfield, Virginia, United States | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Lars-Goran Carlsson, MD | AstraZeneca |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01136655 History of Changes |
| Other Study ID Numbers: | D589GC00002 |
| Study First Received: | June 1, 2010 |
| Last Updated: | September 25, 2012 |
| Health Authority: | Bulgaria: Bulgarian Drug Agency Czech Republic: State Institute for Drug Control Hungary: National Institute of Pharmacy Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products South Africa: Medicines Control Council United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
asthmatic children Symbicort Foradil |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide Formoterol Symbicort Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013