Clinical trial NCT01136655: A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and Foradil® Evaluating Efficacy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: asthmatic children
Symbicort
Foradil
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-06-03
Enrollment: 54
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Average 12 Hour Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose
Secondary outcomes:
measure: FEV1 at 12 Hours After Study Medication Inhalation
timeFrame: 12 hours after dosing
measure: Maximal FEV1 During the 12-hour Study Period
timeFrame: at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose
measure: Urinary Excretion of Formoterol During the 12 Hours Following Inhalation of Study Drug
timeFrame: 0 to 12 hours
Other outcomes:
Locations:
city: Huntington
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Mission Viejo
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: Rolling Hills Estate
country: United States
facility: Research Site
state: California
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Morrisville
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Eugene
country: United States
facility: Research Site
state: Oregon
city: Lake Oswego
country: United States
facility: Research Site
state: Oregon
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Altoona
country: United States
facility: Research Site
state: Pennsylvania
city: Upland
country: United States
facility: Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: El Paso
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Waco
country: United States
facility: Research Site
state: Texas
city: Springfield
country: United States
facility: Research Site
state: Virginia
city: Dublin
country: Bulgaria
facility: Research Site
city: Dublin
country: Czech Republic
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Dublin
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Sopron
country: Hungary
facility: Research Site
city: Dublin
country: Poland
facility: Research Site
city: Krugersdorp
country: South Africa
facility: Research Site
state: Gauteng
city: Pietermariztburg
country: South Africa
facility: Research Site
state: Kwa Zulu Natal
city: Durban
country: South Africa
facility: Research Site
state: Kz-natal
city: Cape Town
country: South Africa
facility: Research Site
state: W Cape
city: Claremont
country: South Africa
facility: Research Site
state: W Cape
city: Cape Town
country: South Africa
facility: Research Site
city: Dublin
country: South Africa
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Lars-Goran Carlsson, MD
role: STUDY_DIRECTOR
References:
citation: 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.