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

Asthma Clinical Trial

— CHASE 2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136655
• Other study ID #: D589GC00002
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2010
• Last updated: October 30, 2013
• Start date: September 2010
• Est. completion date: December 2011

Study information

• Verified date: October 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSouth Africa: Medicines Control CouncilUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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 ß2-agonist (SABA) and at least 48 hours after the last dose of inhaled long-acting ß2-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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Bulgaria	Research Site	Dublin
Czech Republic	Research Site	Dublin
Hungary	Research Site	Budapest
Hungary	Research Site	Dublin
Hungary	Research Site	Miskolc
Hungary	Research Site	Sopron
Poland	Research Site	Dublin
South Africa	Research Site	Cape Town	W Cape
South Africa	Research Site	Cape Town
South Africa	Research Site	Claremont	W Cape
South Africa	Research Site	Dublin
South Africa	Research Site	Durban	Kz-natal
South Africa	Research Site	Krugersdorp	Gauteng
South Africa	Research Site	Pietermariztburg	Kwa Zulu Natal
United States	Research Site	Altoona	Pennsylvania
United States	Research Site	Charleston	South Carolina
United States	Research Site	El Paso	Texas
United States	Research Site	Eugene	Oregon
United States	Research Site	Huntington	California
United States	Research Site	Lake Oswego	Oregon
United States	Research Site	Long Beach	California
United States	Research Site	Medford	Oregon
United States	Research Site	Mission Viejo	California
United States	Research Site	Morrisville	North Carolina
United States	Research Site	Omaha	Nebraska
United States	Research Site	Orange	California
United States	Research Site	Portland	Oregon
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Rolling Hills Estate	California
United States	Research Site	San Antonio	Texas
United States	Research Site	Sarasota	Florida
United States	Research Site	Springfield	Virginia
United States	Research Site	Upland	Pennsylvania
United States	Research Site	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Bulgaria,  Czech Republic,  Hungary,  Poland,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average 12 Hour Forced Expiratory Volume in 1 Second (FEV1)	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.	at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose	No
Secondary	FEV1 at 12 Hours After Study Medication Inhalation	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.	12 hours after dosing	No
Secondary	Maximal FEV1 During the 12-hour Study Period	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.	at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose	No
Secondary	Urinary Excretion of Formoterol During the 12 Hours Following Inhalation of Study Drug	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.	0 to 12 hours	No