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

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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.


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.
We found this trial at
4
sites
Portland, Oregon 97202
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Portland, OR
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Medford, Oregon 97504
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Medford, OR
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San Antonio, Texas 78229
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San Antonio, TX
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Seattle, Washington 98105
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Seattle, WA
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