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

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ClinicalTrials.gov Identifier: NCT01136655

Recruitment Status : Completed

First Posted : June 3, 2010

Results First Posted : August 30, 2013

Last Update Posted : October 31, 2013

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: 80/2.25 μg Symbicort pMDI Drug: 80/4.5 μg Symbicort pMDI Drug: Foradil Aerolizer 12 μg Drug: 40 μg budesonide HFA pMDI Drug: placebo HFA pMDI	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	54 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Quadruple (Participant, Care Provider, 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
Study Start Date :	September 2010
Actual Primary Completion Date :	December 2011
Actual Study Completion Date :	December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Formoterol Arformoterol Tartrate

Genetic and Rare Diseases Information Center resources: Oculocerebral Syndrome With Hypopigmentation

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	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
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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

FEV1 at 12 Hours After Study Medication Inhalation [ Time Frame: 12 hours after dosing ]
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. The FEV1 value at 12 hours after dosing was taken as the 12-hour measurement (720 minutes) from the serial spirometry. 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.
Maximal FEV1 During the 12-hour Study Period [ 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 measured at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes post administration of randomized study medication. The maximum FEV1 value was defined as the largest observed FEV1 value recorded during each 12-hour serial spirometry procedure. 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.
Urinary Excretion of Formoterol During the 12 Hours Following Inhalation of Study Drug [ Time Frame: 0 to 12 hours ]
The amount of formoterol excreted unchanged in urine over the 12-hour period after administration [Ae(0-12h)] was calculated from the concentration of formoterol in urine multiplied by the total volume of urine collected. Volume was determined from the weight of the collected urine times an assumed urine density of 1020 g/L. The data for six patients who did not have measurable formoterol in their urine on the Foradil 12 μg treatment day was excluded from the analysis. All other urine concentrations below the lower limit of quantification were set to zero. 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.

Eligibility Criteria

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Ages Eligible for Study:	6 Years to 11 Years (Child)
Sexes Eligible for Study:	All
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 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.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136655

Locations

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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
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San Antonio, Texas, United States
Research Site
Waco, Texas, United States
United States, Virginia
Research Site
Springfield, Virginia, United States
Bulgaria
Research Site
Dublin, Bulgaria
Czech Republic
Research Site
Dublin, Czech Republic
Hungary
Research Site
Budapest, Hungary
Research Site
Dublin, Hungary
Research Site
Miskolc, Hungary
Research Site
Sopron, Hungary
Poland
Research Site
Dublin, Poland
South Africa
Research Site
Krugersdorp, Gauteng, South Africa
Research Site
Pietermariztburg, Kwa Zulu Natal, South Africa
Research Site
Durban, Kz-natal, South Africa
Research Site
Cape Town, W Cape, South Africa
Research Site
Claremont, W Cape, South Africa
Research Site
Cape Town, South Africa
Research Site
Dublin, South Africa

Sponsors and Collaborators

AstraZeneca

Investigators

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Study Director:	Lars-Goran Carlsson, MD	AstraZeneca

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Berger WE, Gillen M, Eckerwall G, Uryniak T, Trudo FJ, Lampl KL. Bronchodilator effect of single-dose formoterol administered by pressurized metered-dose inhaler in children with asthma aged 6 to <12 years receiving budesonide. Allergy Asthma Proc. 2014 Mar-Apr;35(2):134-40. doi: 10.2500/aap.2014.35.3746.

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Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01136655
Other Study ID Numbers:	D589GC00002
First Posted:	June 3, 2010 Key Record Dates
Results First Posted:	August 30, 2013
Last Update Posted:	October 31, 2013
Last Verified:	October 2013

Keywords provided by AstraZeneca:


asthmatic children Symbicort Foradil

Additional relevant MeSH terms:

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Budesonide Formoterol Fumarate Budesonide, Formoterol Fumarate Drug Combination Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents	Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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