Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic profiles of A006 (Albuterol Dry Powder Inhaler (DPI)), in comparison with those of an active control, Proventil-HFA (Albuterol Metered Dose Inhaler (MDI)), and a Placebo DPI in escalating and cumulative-doses up to 1440 mcg, eight (8) times of the proposed clinical dose.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amphastar Pharmaceuticals, Inc.
• Treatments: Albuterol

Criteria

Inclusion Criteria:

• Body weight ≥ 50 kg for men and ≥ 45 kg for women, and BMI within the range of 18.5 - 30.0 kg/m2 inclusive;

• Sitting blood pressure ≤ 135/90 mmHg;

• Demonstrating negative alcohol/drug screen tests;

• Demonstrating negative HIV, HBsAg and HCV-Ab screen tests;

• 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 Mean Screening Baseline FEV1 at 50.0 - 85.0 % of predicted normal;

• Demonstrating a ≥ 15.0% Airway Reversibility in FEV1 within 30(±5) min after inhaling 2 actuations of Proventil-HFA;

• Demonstrating Peak Inspiratory Flow Rate within 80-150 L/min;

• Demonstrating proficiency in the use of DPI and MDI after training;

• Females of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;

• Having properly consented to participate in the trial.

Exclusion Criteria:

• Smoking history of ≥ 10 pack-years, or having smoked within 6 months prior to Screening;

• Upper respiratory tract infections within 2 wk, or lower respiratory tract infection within 4 wk;

• Asthma exacerbations that required emergency care or hospitalized treatment, within 4 wk prior;

• Any current or recent respiratory conditions that might significantly affect pharmacodynamic response to the study drugs, besides asthma;

• Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignancies, or other illnesses that could impact on the conduct, safety and evaluation of the study;

• Known intolerance or hypersensitivity to any of the ingredients of the A006 or Proventil-HFA;

• 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;

• Having donated blood within the last 30 days prior to Screening.