4-Week Study of Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric Asthma

NCT00634517 | Terminated Phase 3

• 1 other identifier: API-A004-CLN-E
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 8

Brief Summary

This 4-week clinical study evaluates the efficacy and safety of Albuterol Sulfate HFA Inhalation Aerosol in comparison with the Active Control, Proventil-HFA (3M Pharmaceuticals, Inc) in pediatric patients (4-11 years old) with mild-to-moderate asthma. In addition, pharmacokinetic profile in this population will be evaluated using a population PK approach with sparse blood samples.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• The primary endpoint for efficacy evaluation is to obtain the ratio of the geometric mean of area under the curve of change in FEV1%versus time for pediatric patients using the study drug to the active reference drug.

  visits 1 and 3

Secondary Outcomes (20)

• AUC of serial FEV1 volume changes from the Same Day Baseline versus time, during the 6-hr post-dose.

  each visit

• Time to onset of bronchodilator effect, determined by linear interpolation as the time point when FEV1 first exceeded 12.0% over the respective Same Day Baseline.

  each visist

• The peak bronchodilator response, Fmax, defined as the maximum FEV1 (% change from the Same Day Baseline).

  each visit

• The time to peak bronchodilator response (FEV1), with Fmax defined as the maximum FEV1 (% change from the Same Day Baseline).

  each visit

• Duration of bronchodilator effect, defined as the total duration when FEV1 is maintained greater than or equal to 12.0% above the respective Same Day Baseline values.

  each visit

Study Arms (2)

T

EXPERIMENTAL

Armstrong Albuterol Sulfate Inhalation Aerosol, 216 mcg albuterol sulfate (108 mcg/actuation) is equivalent to 180 mcg albuterol base (90 mcg/actuation).

Drug: Armstrong Albuterol Sulfate Inhalation Aerosol

R

ACTIVE COMPARATOR

Proventil-HFA, Albuterol Sulfate Inhalation Aerosol, 216 mcg albuterol sulfate (108 mcg/actuation) is equivalent to 180 mcg albuterol base (90 mcg/actuation).

Drug: Albuterol Sulfate Inhalation Aerosol

Interventions

Armstrong Albuterol Sulfate Inhalation Aerosol DRUG

Albuterol Sulfate Inhalation Aerosol, 216 mcg albuterol sulfate (108 mcg/actuation) is equivalent to 180 mcg albuterol base (90 mcg/actuation).

Also known as: Albuterol HFA

T

Albuterol Sulfate Inhalation Aerosol DRUG

Albuterol Sulfate Inhalation Aerosol, 216 mcg albuterol sulfate (108 mcg/actuation) is equivalent to 180 mcg albuterol base (90 mcg/actuation).

Also known as: Proventil-HFA

R

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Generally healthy.
• Male and female mild-to-moderate asthma patients.
• Aged 4 - 11 yr (upon screening).
• Female patients must be premenarchal upon Visit-1, and those who become menarchal during the study must use an accepted method of contraception including abstinence.
• A documented history of asthma, for at-least 6-months prior to Screening, requiring inhaled B-adrenergic agonists, with or without inhaled corticosteroids for asthma symptom control.
• Satisfying asthma stability criterion, defined as no changes in asthma therapy and no asthma-related hospitalization or emergency room visits, over the 4 weeks prior to Screening.
• Being able to withhold treatment with inhaled bronchodilators and/or restricted medications for the minimum washout periods indicated in Appendix II, for the purpose of conducting clinical visits.
• Having a baseline forced expiratory volume in 1 second (FEV1), that is 50.0-100.0% of predicted values at the screening (Screening Baseline FEV1).
• Demonstrating a greater than or equal to 12.0% reversibility in the Reversibility Test, at 30 min after inhaling 2-4 puffs (180-360 mcg) of Ventolin-HFA.
• Demonstrating correct use of metered-dose inhaler (MDIs), and acceptable performance in the FEV1 measurements.
• Has properly consented, with a parent or a legal guardian, to participate in this study.

You may not qualify if:

• Any current or past significant medical conditions that, according to the investigator, might affect pharmacodynamic response to the study drugs, such as significant systemic or respiratory diseases (e.g., cystic fibrosis, bronchiectasis, emphysema, nonreversible pulmonary diseases), other than asthma.
• Concurrent clinically significant cardiovascular, hematological, renal, neurological, hepatic, and endocrine disorders, or psychiatric diseases.
• Known intolerance or hypersensitivity to any component of the MDI formulation (e.g., albuterol, HFA-134a, oleic acid, ethanol).
• Recent upper (within 2 weeks) or lower (within 4 weeks) respiratory tract infection before screening.
• Recent (within 4 weeks) use of systemic (or oral) corticosteroids and B-adrenergic bronchodilators; or recent (within 2 weeks) use of monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), or B-blockers; before the Screening.
• Having been on other investigational drug/device studies in the last 30 days prior to screening.
• Known or reasonably suspected alcohol/drug abuses.
• Having smoked within the last 12 months.

Sponsors & Collaborators

• Amphastar Pharmaceuticals, Inc.: lead

Study Sites (8)

West Coast Clinical Trials Phase 2-4, LLC

Long Beach, California, 90806, United States

Location

Allergy Associates Medical Group, Inc.

San Diego, California, 92120, United States

Location

Bensch Research Associates

Stockton, California, 95207, United States

Location

Integrated Medical Research

Ashland, Oregon, 97520, United States

Location

Allergy and Asthma Research Group

Eugene, Oregon, 97401, United States

Location

Clinical Research Institute of Southern Oregon

Medford, Oregon, 97504, United States

Location

Allergy Associates Research Center

Portland, Oregon, 97213, United States

Location

Pharmaceutical Research & Consulting, Inc.

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

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; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2008
• First Posted: March 13, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 15, 2013

Record last verified: 2013-07

Locations

US (8)