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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma Bronchospasm Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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T

Four doses of A006 taken in 30 minute intervals. Doses will have an escalating number of inhalations (1, 1, 2, and 4 inhalations). Total cumulative Albuterol dose at 90 minutes is 1440 mcg.

Group Type EXPERIMENTAL

A006

Intervention Type DRUG

Albuterol DPI with 180 mcg Albuterol/inhalation

R

Four doses of Proventil-HFA taken in 30 minute intervals. Doses will have an escalating number of inhalations (2, 2, 4, and 8 inhalations). Total cumulative Albuterol dose at 90 minutes is 1440 mcg.

Group Type ACTIVE_COMPARATOR

Proventil-HFA

Intervention Type DRUG

Albuterol MDI with 90 mcg Albuterol/inhalation

P

Four doses of Placebo DPI taken in 30 minute intervals. Doses will have an escalating number of inhalations (1, 1, 2, and 4 inhalations). Total cumulative Albuterol dose at 90 minutes is 0 mcg.

Group Type PLACEBO_COMPARATOR

Placebo DPI

Intervention Type DRUG

Placebo DPI with 0 mcg Albuterol/inhalation

Interventions

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A006

Albuterol DPI with 180 mcg Albuterol/inhalation

Intervention Type DRUG

Placebo DPI

Placebo DPI with 0 mcg Albuterol/inhalation

Intervention Type DRUG

Proventil-HFA

Albuterol MDI with 90 mcg Albuterol/inhalation

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No