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:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01136655
First received: June 1, 2010
Last updated: October 30, 2013
Last verified: October 2013
  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: 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

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:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


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: 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

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136655

  Show 34 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Lars-Goran Carlsson, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01136655     History of Changes
Other Study ID Numbers: D589GC00002
Study First Received: June 1, 2010
Results First Received: November 12, 2012
Last Updated: October 30, 2013
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:
Budesonide
Formoterol
Symbicort
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014