Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Proventil 90 μg; Drug: AS MDI 90 μg; Drug: AS MDI 180 µg; Other: Placebo MDI; Drug: Proventil 180 μg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03364608

D6930C00001

Details and patient eligibility

About

This is a randomized, double-blind, single-dose, placebo-controlled, 5-period, 5-treatment, crossover, multi-center study to assess the bronchodilatory effect and safety of 2 dose levels of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI), 90 μg and 180 μg, compared with placebo for AS MDI (hereafter referred to as Placebo MDI) and open-label Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) 90 μg and 180 μg in adult and adolescent subjects with mild to moderate asthma. This study design utilizes 10 treatment sequences.

Full description

This is a 5-period crossover study. Each Treatment Period is 1 day. Subjects will receive a single dose of randomized study drug at each of the 5 Treatment Visits (Visits 2, 3, 4, 5, and 6), with a 3- to 7-day Washout Period between Treatment Visits.

Enrollment: 86 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Are at least 12 years of age and no older than 65 years
• Have stable (for 6 months) physician-diagnosed asthma with historical documentation of the diagnosis
• Must be receiving 1 of the following required inhaled asthma therapies listed below for at least the last 30 days; Only SABA, which is used as needed for rescue, or Low to medium doses of ICS (alone or in combination with LABA), used regularly as maintenance asthma therapy
• Demonstrate acceptable spirometry performance (ie, meet American Thoracic Society [ATS]/European Respiratory Society [ERS] acceptability/repeatability criteria
• Pre-bronchodilator FEV1 of ≥40 to <90% predicted normal value after withholding SABA for ≥6 hours
• Confirmed FEV1 reversibility to Ventolin, defined as a post-Ventolin increase in FEV1 of ≥15%
• only 2 reversibility testing attempts are allowed

Exclusion Criteria:

• Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
• Oral corticosteroid use (any dose) within 6 weeks
• Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months (including all forms of tobacco, e-cigarettes [vaping], and marijuana)
• Life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s)
• Historical or current evidence of a clinically significant disease
• Cancer not in complete remission for at least 5 years
• Hospitalized for psychiatric disorder or attempted suicide within 1 year
• Unable to abstain from protocol-defined prohibited medications during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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86 participants in 5 patient groups, including a placebo group

• AS MDI 90 µg

Experimental group

Description:

(2 actuations of 45 µg/actuation)

Treatment:

Drug: AS MDI 90 μg

• AS MDI 180 µg

Experimental group

Description:

(2 actuations of 90 µg/actuation)

Treatment:

Drug: AS MDI 180 µg

• Placebo MDI

Placebo Comparator group

Description:

(2 actuations)

Treatment:

Other: Placebo MDI

• Proventil 90 µg

Active Comparator group

Description:

(1 actuation of 90 µg/actuation)

Treatment:

Drug: Proventil 90 μg

• Proventil 180 µg

Active Comparator group

Description:

(2 actuations of 90 µg/actuation)

Treatment:

Drug: Proventil 180 μg