Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation

Amphastar Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Albuterol MDI 90 mcg/inh; Drug: Albuterol DPI 90 mcg/inh; Drug: Albuterol DPI 25 mcg/inh; Drug: Placebo DPI

Study type: Interventional

Funder types: Industry

Identifiers

NCT01581177

API-A006-CL-B2

Details and patient eligibility

About

The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dosing in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control.

This study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma for at least 6 months, but are otherwise generally healthy.

Full description

The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dose in comparison to the DPI Placebo Control and the Active (Reference) Control. The study results of this study together with that of A006-B study will be utilized to determine the optimum final dose range of A006 for further clinical studies.

The study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma but are otherwise generally healthy.

Enrollment: 23 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Generally healthy, male and female adults, 18-55 years of age at screening
• With mild-to-moderate persistent asthma for at least 6 months prior to screening and having used a beta-agonist(s) inhaler
• Demonstrate a Forced Expiratory Volume (FEV1) at 50-85 percent of predicted normal during screening baseline measurement
• Demonstrate an airway reversibility of greater than or equal to 15 percent within 30 minutes of inhaling 2 inhalations of Proventil MDI during screening visit
• Demonstrate Peak Inspiratory Flow Rate (PIF) within 80-150 L/min (after training), at least 2 times consecutively
• Demonstrate ability to use a DPI and MDI inhaler properly after training
• Females must be not pregnant, not lactating, and using a clinically acceptable form of birth control
• Properly agree to participate in the trial

Exclusion criteria

• A smoking history of more than or equal to 10 years or having smoked within 6 months of screening visit
• Upper respiratory tract infections within 2 weeks or lower respiratory tract infection within 4 weeks prior to screening visit
• Asthma exacerbations that required emergency care or a hospital stay within 4 weeks prior to screening visit
• Any current or recent respiratory tract infections that might affect the response to the study drug as determined by the investigator, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema and other significant respiratory diseases besides asthma
• Current clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant or other illnesses that could impact the study as determined by the investigator
• Known intolerance or hypersensitivity to any ingredients of the study drug DPI or Proventil MDI (i.e.: Albuterol, sulfate, lactose, milk protein, HFA-134a, oleic acid and ethanol)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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23 participants in 7 patient groups, including a placebo group

T1

Experimental group

Description:

Two inhalations, one of Albuterol DPI 25 mcg/inh and one of Placebo DPI; Total Albuterol dose of 25 mcg

Treatment:

Drug: Placebo DPI

Drug: Albuterol DPI 25 mcg/inh

T2

Experimental group

Description:

Two inhalations of Albuterol DPI 25 mcg/inh; Total Albuterol dose of 50 mcg

Treatment:

Drug: Albuterol DPI 25 mcg/inh

T3

Experimental group

Description:

Two inhalations, one of Albuterol DPI 90 mcg/inh and one of Placebo DPI; Total Albuterol dose of 90 mcg

Treatment:

Drug: Placebo DPI

Drug: Albuterol DPI 90 mcg/inh

T4

Experimental group

Description:

Two inhalations of Albuterol DPI 90 mcg/inh; Total Albuterol dose of 180 mcg

Treatment:

Drug: Albuterol DPI 90 mcg/inh

P

Placebo Comparator group

Description:

Two inhalations Placebo DPI; Total Albuterol dose of 0 mcg

Treatment:

Drug: Placebo DPI

R1

Active Comparator group

Description:

One inhalation of Albuterol MDI 90 mcg/inh; Total Albuterol dose of 90 mcg

Treatment:

Drug: Albuterol MDI 90 mcg/inh

R2

Active Comparator group

Description:

Two inhalations of Albuterol MDI 90 mcg/inh; Total Albuterol dose of 180 mcg

Treatment:

Drug: Albuterol MDI 90 mcg/inh