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

NCT ID: NCT01025648

Last Updated: 2018-05-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2009-12-31

Brief Summary

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

T1 - E004 90 mcg/actuation

T1 - E004 (epinephrine inhalation aerosol) 90 mcg/actuation - treatment by 2 actuations of E004 at 90 mcg/actuation

Group Type: EXPERIMENTAL

E004 (epinephrine inhalation aerosol), 90 mcg/actuation

Intervention Type: DRUG

E004 (epinephrine inhalation aerosol), 90 mcg/actuation, 2 actuations, single dose crossover, 1 -14 day washout period

T2 - E004 125 mcg/actuation

E004 (epinephrine inhalation aerosol), 125 mcg, 2 actuations

Group Type: EXPERIMENTAL

E004 (epinephrine inhalation aerosol), 125 mcg

Intervention Type: DRUG

E004 (epinephrine inhalation aerosol), 125 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 day washout period

T3 - 160 mcg/actuation

E004 (epinephrine inhalation aerosol), 160 mcg - E004 (epinephrine inhalation aerosol), 160 mcg/ actuation, 2 actuations

Group Type: EXPERIMENTAL

E004 (epinephrine inhalation aerosol), 160 mcg

Intervention Type: DRUG

E004 (epinephrine inhalation aerosol), 160 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 days washout period

T4 - 220 mcg/actuation

E004 (epinephrine inhalation aerosol), 220 mcg - 220 mcg/actuation, 2 actuations

Group Type: EXPERIMENTAL

E004 (epinephrine inhalation aerosol), 220 mcg

Intervention Type: DRUG

E004 (epinephrine inhalation aerosol), 220 mcg - 220 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 days washout period

A - Active control

epinephrine inhalation aerosol, CFC propelled 220 mcg Epinephrine Inhalation Aerosol, CFC-MDI, 2 actuations

Group Type: ACTIVE_COMPARATOR

epinephrine inhalation aerosol, CFC propelled

Intervention Type: DRUG

epinephrine inhalation aerosol, 220 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 day washout period

P, Placebo HFA

E004 placebo single treatment with 2 inhalations

Group Type: PLACEBO_COMPARATOR

E004 Placebo

Intervention Type: DRUG

E004 Placebo, 0 mcg epinephrine inhalation aerosol, 2 actuations, 1 -14 day washout period

Interventions

E004 (epinephrine inhalation aerosol), 90 mcg/actuation

E004 (epinephrine inhalation aerosol), 90 mcg/actuation, 2 actuations, single dose crossover, 1 -14 day washout period

Intervention Type: DRUG

E004 Placebo

E004 Placebo, 0 mcg epinephrine inhalation aerosol, 2 actuations, 1 -14 day washout period

Intervention Type: DRUG

E004 (epinephrine inhalation aerosol), 125 mcg

E004 (epinephrine inhalation aerosol), 125 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 day washout period

Intervention Type: DRUG

E004 (epinephrine inhalation aerosol), 220 mcg

E004 (epinephrine inhalation aerosol), 220 mcg - 220 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 days washout period

Intervention Type: DRUG

epinephrine inhalation aerosol, CFC propelled

epinephrine inhalation aerosol, 220 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 day washout period

Intervention Type: DRUG

E004 (epinephrine inhalation aerosol), 160 mcg

E004 (epinephrine inhalation aerosol), 160 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 days washout period

Intervention Type: DRUG

Other Intervention Names

Primatene Mist HFA; Primatene Mist HFA; Primatene Mist HFA; Primatene Mist; Primatene Mist HFA

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amphastar Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jim Shi, M.D., Ph.D.

Role: STUDY_CHAIR

Amphastar Pharmaceuticals, Inc.

Locations

Amphastar Site 0001

San Jose, California, United States

Amphastar Site 0003

Stockton, California, United States

Countries

United States

References

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Other Identifiers

API-E004-CL-A

Identifier Type: -

Identifier Source: org_study_id