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

NCT01136655 | Completed Phase 2 Results

• 1 other identifier: D589GC00002
• Study Type: interventional
• Target: 54
• Locations: 6 countries
• Sites: 34

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.

Conditions

Asthma

Keywords

asthmatic children; Symbicort; Foradil

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• FEV1 at 12 Hours After Study Medication Inhalation

  12 hours after dosing

• Maximal FEV1 During the 12-hour Study Period

  at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose

• Urinary Excretion of Formoterol During the 12 Hours Following Inhalation of Study Drug

  0 to 12 hours

Study Arms (5)

BUD 160/FM 2.25

EXPERIMENTAL

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; Drug: 40 μg budesonide HFA pMDI

BUD 160/FM 4.5

EXPERIMENTAL

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; Drug: placebo HFA pMDI

BUD 160/FM 9.0

EXPERIMENTAL

placebo HFA pMDI × 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI × 2 inhalations)

Drug: 80/4.5 μg Symbicort pMDI; Drug: placebo HFA pMDI

BUD 160

PLACEBO COMPARATOR

placebo HFA pMDI × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations

Drug: 40 μg budesonide HFA pMDI; Drug: placebo HFA pMDI

BUD 160/Foradil 12.0

ACTIVE COMPARATOR

Foradil Aerolizer 12 μg × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations

Drug: Foradil Aerolizer 12 μg; Drug: 40 μg budesonide HFA pMDI

Interventions

80/2.25 μg Symbicort pMDI DRUG

inhalation

BUD 160/FM 2.25; BUD 160/FM 4.5

80/4.5 μg Symbicort pMDI DRUG

inhalation

BUD 160/FM 9.0

Foradil Aerolizer 12 μg DRUG

inhalation

BUD 160/Foradil 12.0

40 μg budesonide HFA pMDI DRUG

inhalation

BUD 160; BUD 160/FM 2.25; BUD 160/Foradil 12.0

placebo HFA pMDI DRUG

inhalation

BUD 160; BUD 160/FM 4.5; BUD 160/FM 9.0

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (34)

Research Site

Huntington, California, United States

Location

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Long Beach, California, United States

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Mission Viejo, California, United States

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Orange, California, United States

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Rolling Hills Estate, California, United States

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Sarasota, Florida, United States

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Omaha, Nebraska, United States

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Morrisville, North Carolina, United States

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Raleigh, North Carolina, United States

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Eugene, Oregon, United States

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Lake Oswego, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Altoona, Pennsylvania, United States

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Upland, Pennsylvania, United States

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Charleston, South Carolina, United States

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El Paso, Texas, United States

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San Antonio, Texas, United States

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Waco, Texas, United States

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Springfield, Virginia, United States

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Dublin, Bulgaria

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Dublin, Czechia

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Budapest, Hungary

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Dublin, Hungary

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Miskolc, Hungary

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Sopron, Hungary

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Dublin, Poland

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Krugersdorp, Gauteng, South Africa

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Pietermariztburg, KwaZulu-Natal, South Africa

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Durban, Kz-natal, South Africa

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Cape Town, South Africa, South Africa

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Cape Town, W Cape, South Africa

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Claremont, W Cape, South Africa

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Dublin, South Africa

Location

Related Publications (1)

• 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.

  PMID: 24717790 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Göran Eckerwall, MSD
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Lars-Goran Carlsson, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: June 3, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 31, 2013
• Results First Posted: August 30, 2013

Record last verified: 2013-10

Locations

HU (4); ZA (7); US (20); CZ (1); PL (1); BU (1)