Clinical trial NCT03364608: Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma
Official title: A Randomized, Double-blind, Single Dose, Placebo-controlled, 5-Period, 5-Treatment, Crossover, Multi-center, Dose-ranging Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Mild to Moderate Asthma (ANTORA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-12-06
Enrollment: 86
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in FEV1 AUC0-6
timeFrame: Over 6 hours post dose on Day 1
Secondary outcomes:
measure: Change From Baseline in FEV1 AUC0-4
timeFrame: Over 4 hours post dose on Day 1
measure: Peak Change From Baseline in FEV1
timeFrame: Over 6 hours post dose on Day 1
Other outcomes:
Locations:
city: Rolling Hills Estates
country: United States
facility: Research Site
state: California
city: Stockton
country: United States
facility: Research Site
state: California
city: Winter Park
country: United States
facility: Research Site
state: Florida
city: North Dartmouth
country: United States
facility: Research Site
state: Massachusetts
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: El Paso
country: United States
facility: Research Site
state: Texas
Study officials:
References:
citation: Cappelletti C, Maes A, Rossman K, Gillen M, LaForce C, Kerwin EM, Reisner C. Dose-Ranging and Cumulative Dose Studies of Albuterol Sulfate MDI in Co-Suspension Delivery Technology (AS MDI; PT007) in Patients with Asthma: the ASPEN and ANTORA Trials. Clin Drug Investig. 2021 Jun;41(6):579-590. doi: 10.1007/s40261-021-01040-7. Epub 2021 Jun 4.