Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006
Status: | Completed |
---|---|
Conditions: | Asthma, Chronic Obstructive Pulmonary Disease, Pulmonary, Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 5/20/2017 |
Start Date: | July 2010 |
End Date: | January 2011 |
A Randomized, Double- or Evaluator-blinded, Active- and Placebo-controlled, Cumulative-dose, Dose-escalating, Three-arm, Cross-over Study, in 24 Asthma Patients
The main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic
profiles of A006, in comparison with those of an active control, Proventil®-HFA MDI, and a
placebo control DPI, in escalating and cumulative-doses up to 1,440 mcg, eight (8) times of
the proposed clinical dose.
profiles of A006, in comparison with those of an active control, Proventil®-HFA MDI, and a
placebo control DPI, in escalating and cumulative-doses up to 1,440 mcg, eight (8) times of
the proposed clinical dose.
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® MDI;
- 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 study drug DPI
or Proventil® MDI;
- 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.
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