Randomized, Placebo/Active Crossover Dose-ranging Study for Safety and Efficacy in Asthma Patients.



Status:Terminated
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 55
Updated:5/18/2018
Start Date:December 2009
End Date:December 2009

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A Randomized, Double-blinded or Evaluator-blinded, Placebo and Active Controlled, Six-arm, Crossover, Single Dose, Dose-ranging Study, for Initial Evaluation of Safety and Efficacy in Asthma Patients

The main objective of this study is to evaluate the efficacy and safety of the Armstrong's
Epinephrine HFA-MDI (E004) formulation, in comparison to the Placebo (Placebo-HFA) and an
Active Control (Epinephrine CFC-MDI), and to identify the optimum E004 dose strength(s) for
the ensuing pivotal clinical trials. The study will be conducted in adult patients who have
intermittent, or mild-to-moderate persistent, asthma, but are otherwise healthy.

The bronchodilatory efficacy of E004, is evaluated in terms of post-dose area under the
curves (AUC) of FEV1 changes (% and volumes), from the pre-dose baseline values, in
comparison to the Placebo Control and the Active Control.


Inclusion Criteria:

1. Generally healthy, male and female adults aged 18 to 55 years at Screening.

2. Clinical diagnosis of intermittent, or mild-to-moderate persistent, asthma for at
least 6 months before Screening, and having used inhaled epinephrine or β-agonist(s)
for asthma control;

3. Demonstrating a baseline forced expiratory volume in 1 second (FEV1) at 50-90 percent
of predicted normal at Screening;

4. Demonstrating a 12.0 percent or greater airway reversibility in FEV1 within 30 min
after inhaling 2 actuations of Epinephrine CFC-MDI (440 mcg Epinephrine base) at
Screening;

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

6. Demonstration of proficiency in the use of a MDI inhaler after training;

7. Having properly consented to participate in the trial.

Exclusion Criteria:

1. A smoking history of 10 or more pack-years, or having smoked within 6 months prior to
Screening;

2. Upper respiratory tract infections within 2 wk, or lower respiratory tract infection
within 4 wk, prior to Screening;

3. Asthma exacerbations that required emergency care or hospitalized treatment, within 4
wk prior to Screening;

4. 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;

5. Concurrent clinically significant cardiovascular, hematological, renal, neurologic,
hepatic, endocrine (including diabetes), psychiatric, neoplastic or other illnesses
that in the opinion of the investigator could impact on the conduct, safety and
evaluation of the study;

6. Known intolerance or hypersensitivity to any of the study MDI ingredients (i.e.,
Epinephrine, HFA-134a, CFC-12, CFC-114, polysorbate-80, ethanol, thymol, nitric acid
and ascorbic acid);

7. Use of prohibited drugs or failure to observe the drug washout restrictions;

8. Having been on other investigational drug/device studies in the last 30 days prior to
Screening.
We found this trial at
2
sites
San Jose, California 95117
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San Jose, CA
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Stockton, California 95207
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Stockton, CA
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