NCT03364608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_2 asthma

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_2 asthma

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

December 15, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 24, 2019

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

December 1, 2017

Results QC Date

March 29, 2019

Last Update Submit

July 23, 2019

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in FEV1 AUC0-6

    Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-6 (Area under the curve from 0 to 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose) normalized for length of follow up.

    Over 6 hours post dose on Day 1

Secondary Outcomes (2)

  • Change From Baseline in FEV1 AUC0-4

    Over 4 hours post dose on Day 1

  • Peak Change From Baseline in FEV1

    Over 6 hours post dose on Day 1

Study Arms (5)

• AS MDI 90 µg

EXPERIMENTAL

(2 actuations of 45 µg/actuation)

Drug: AS MDI 90 μg

• AS MDI 180 µg

EXPERIMENTAL

(2 actuations of 90 µg/actuation)

Drug: AS MDI 180 µg

• Placebo MDI

PLACEBO COMPARATOR

(2 actuations)

Other: Placebo MDI

• Proventil 90 µg

ACTIVE COMPARATOR

(1 actuation of 90 µg/actuation)

Drug: Proventil 90 μg

• Proventil 180 µg

ACTIVE COMPARATOR

(2 actuations of 90 µg/actuation)

Drug: Proventil 180 μg

Interventions

AS MDI 90 μgDRUG

AS MDI 90 μg (2 actuations of 45 μg/actuation)

Also known as: AS MDI
• AS MDI 90 µg
AS MDI 180 µgDRUG

AS MDI 180 μg (2 actuations of 90 μg/actuation)

Also known as: AS MDI
• AS MDI 180 µg
Placebo MDIOTHER

Placebo MDI (2 actuations)

• Placebo MDI
Proventil 90 μgDRUG

Proventil 90 μg (1 actuation of 90 μg/actuation)

Also known as: Proventil
• Proventil 90 µg
Proventil 180 μgDRUG

Proventil 180 μg (2 actuations of 90 μg/actuation)

Also known as: Proventil
• Proventil 180 µg

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

Rolling Hills Estates, California, 90274, United States

Location

Research Site

Stockton, California, 95207, United States

Location

Research Site

Winter Park, Florida, 32789, United States

Location

Research Site

North Dartmouth, Massachusetts, 02747, United States

Location

Research Site

St Louis, Missouri, 63141, United States

Location

Research Site

Raleigh, North Carolina, 27607, United States

Location

Research Site

Cincinnati, Ohio, 45242, United States

Location

Research Site

Medford, Oregon, 97504, United States

Location

Research Site

Spartanburg, South Carolina, 29303, United States

Location

Research Site

El Paso, Texas, 79903, United States

Location

Related Publications (1)

  • 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.

    PMID: 34089147DERIVED

Related Links

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Results Point of Contact

Title
Colin Reisner, MD FCCP, FAAAAI
Organization
Pearl Therapeutics, Inc, a Member of the AstraZeneca Group
Colin.Reisner@astrazeneca.com
9739750321

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2017

First Posted

December 6, 2017

Study Start

December 15, 2017

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

July 24, 2019

Results First Posted

July 24, 2019

Record last verified: 2019-07

Locations

US(10)