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

Trial end date:
Target enrollment:
Participant gender:
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.
Phase 3
Accepts Healthy Volunteers?
Lead Sponsor:
Amphastar Pharmaceuticals, Inc.
Inclusion Criteria:

1. Generally healthy.

2. Male and female mild-to-moderate asthma patients.

3. Aged 4 - 11 yr (upon screening).

4. 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.

5. 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.

6. 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

7. 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.

8. 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).

9. 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.

10. Demonstrating correct use of metered-dose inhaler (MDIs), and acceptable performance
in the FEV1 measurements.

11. Has properly consented, with a parent or a legal guardian, to participate in this

Exclusion Criteria:

1. 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.

2. Concurrent clinically significant cardiovascular, hematological, renal, neurological,
hepatic, and endocrine disorders, or psychiatric diseases.

3. Known intolerance or hypersensitivity to any component of the MDI formulation (e.g.,
albuterol, HFA-134a, oleic acid, ethanol).

4. Recent upper (within 2 weeks) or lower (within 4 weeks) respiratory tract infection
before screening.

5. 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.

6. Having been on other investigational drug/device studies in the last 30 days prior to

7. Known or reasonably suspected alcohol/drug abuses.

8. Having smoked within the last 12 months.