Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation (A006-B3)

Amphastar Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Proventil® MDI; Other: Placebo DPI; Drug: A006 DPI

Study type: Interventional

Funder types: Industry

Identifiers

NCT02210806

API-A006-CL-B3

Details and patient eligibility

About

This study evaluates the efficacy, dose-ranging and safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 110 to 220 mcg per dose in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control.

Full description

This study is designed to evaluate the efficacy and safety profiles of A006 and to assist in identifying the optimum dose of A006 for future clinical studies. Proventil® HFA MDI, a currently marketed Albuterol MDI product, will be used as an Active Control. The study also employs a Placebo Control DPI, which has the same configuration as the A006 DPI except that it contains no active ingredient.

Enrollment: 22 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Generally healthy, male and female adults, 18-55 years of age at Screening
• With mild-to-moderate persistent asthma for at least 6 months prior to Screening, and having used inhaled β-agonist(s) for asthma control
• Demonstrating a Screening Baseline FEV1 at 50.0 - 85.0% of predicted normal
• Demonstrating a ≥ 15.0% Airway Reversibility in FEV1 within 30 min after inhaling 2 actuations of Proventil® MDI (180 mcg) at Screening
• Demonstrating Peak Inspiratory Flow Rate (PIF) within 80-150 L/min (after training), for at least 2 times consecutively with a maximum of 5 attempts
• Demonstrating proficiency in the use of a DPI and an MDI after training
• Females of child-bearing potential must be non-pregnant, non-lactating; both males and females enrolled into the study must agree to practice a clinically acceptable form of birth control (including but not limited to, abstinence, double barrier, etc)
• Having properly consented to participate in the trial

Exclusion criteria

• A smoking history of ≥ 5 pack-years, or having smoked within 6 months prior to Screening
• Upper respiratory tract infections or lower respiratory tract infection within 6 weeks, prior to Screening
• Asthma exacerbations that required emergency care or hospitalized treatment, within 4 weeks prior to Screening
• Any current or recent respiratory conditions that, per investigator discretion, might significantly affect pharmacodynamic response to the study drugs, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema, and other significant respiratory diseases besides asthma
• Concurrent clinically significant cardiovascular (e.g. hypertension and tachyarrhythmia and bradyarrhythmia), hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant, or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study
• Known intolerance or hypersensitivity to any of the ingredients of the study drug DPI or Proventil® HFA MDI (i.e., Albuterol, sulfate, lactose, milk protein, HFA-134a, oleic acid, and ethanol)
• Baseline ECG at Screening or Visit 1 showing any single or multiple premature ventricular contractions (PVC)
• Baseline ECG at Screening or Visit 1 with a confirmed (through performing a second ECG) QTc reading greater than 450ms
• Use of prohibited drugs or failure to observe the drug washout restrictions
• Having been on other clinical drug/device studies in the last 30 days prior to Screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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22 participants in 5 patient groups, including a placebo group

Treatment T1

Active Comparator group

Description:

One inhalation of 110 mcg A006 DPI. Total 110 mcg.

Treatment:

Drug: A006 DPI

Drug: A006 DPI

Treatment T2

Active Comparator group

Description:

One inhalation of 220 mcg A006 DPI. Total 220 mcg.

Treatment:

Drug: A006 DPI

Drug: A006 DPI

Placebo

Placebo Comparator group

Description:

One inhalation of placebo DPI . Total 0 mcg

Treatment:

Other: Placebo DPI

Treatment R1

Active Comparator group

Description:

One inhalation of Proventil® MDI Total 90 mcg

Treatment:

Drug: Proventil® MDI

Drug: Proventil® MDI

Treatment R2

Active Comparator group

Description:

Two inhalations of Proventil® MDI, 180 mcg total

Treatment:

Drug: Proventil® MDI

Drug: Proventil® MDI