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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

AS MDI 90 μg

AS MDI 180 µg

Placebo MDI

Proventil 90 μg

Proventil 180 μg

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

• AS MDI 90 µg

• AS MDI 180 µg

• Placebo MDI

• Proventil 90 µg

• Proventil 180 µg

Arm Description

(2 actuations of 45 µg/actuation)

(2 actuations of 90 µg/actuation)

(2 actuations)

(1 actuation of 90 µg/actuation)

(2 actuations of 90 µg/actuation)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline in FEV1 AUC0-4

Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-4 (Area under the curve from 0 to 4 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose) normalized for length of follow up.

Peak Change From Baseline in FEV1

Peak Change from baseline in FEV1 (Forced expiratory volume in 1 second)

Full Information

NCT ID

NCT03364608

First Posted

December 1, 2017

Last Updated

July 23, 2019

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT03364608

Brief Title

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

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

December 15, 2017 (Actual)

Primary Completion Date

March 30, 2018 (Actual)

Study Completion Date

March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

86 (Actual)

8. Arms, Groups, and Interventions

Arm Title

• AS MDI 90 µg

Arm Type

Experimental

Arm Description

(2 actuations of 45 µg/actuation)

Arm Title

• AS MDI 180 µg

Arm Type

Experimental

Arm Description

(2 actuations of 90 µg/actuation)

Arm Title

• Placebo MDI

Arm Type

Placebo Comparator

Arm Description

(2 actuations)

Arm Title

• Proventil 90 µg

Arm Type

Active Comparator

Arm Description

(1 actuation of 90 µg/actuation)

Arm Title

• Proventil 180 µg

Arm Type

Active Comparator

Arm Description

(2 actuations of 90 µg/actuation)

Intervention Type

Drug

Intervention Name(s)

AS MDI 90 μg

Other Intervention Name(s)

AS MDI

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

AS MDI 180 µg

Other Intervention Name(s)

AS MDI

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo MDI

Intervention Description

Placebo MDI (2 actuations)

Intervention Type

Drug

Intervention Name(s)

Proventil 90 μg

Other Intervention Name(s)

Proventil

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Proventil 180 μg

Other Intervention Name(s)

Proventil

Intervention Description

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

Primary Outcome Measure Information:

Title

Change From Baseline in FEV1 AUC0-6

Description

Time Frame

Over 6 hours post dose on Day 1

Secondary Outcome Measure Information:

Title

Change From Baseline in FEV1 AUC0-4

Description

Time Frame

Over 4 hours post dose on Day 1

Title

Peak Change From Baseline in FEV1

Description

Peak Change from baseline in FEV1 (Forced expiratory volume in 1 second)

Time Frame

Over 6 hours post dose on Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Research Site

City

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

Research Site

City

Stockton

State/Province

California

ZIP/Postal Code

95207

Country

United States

Facility Name

Research Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Research Site

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Research Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Research Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Research Site

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

Research Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79903

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34089147

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.

Results Reference

derived

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=14724&filename=PT007001_Protocol_Redacted_PDFA.pdf

Description

Protocol

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=14724&filename=PT007001_SAP_Redacted_PDFA.pdf

Description

Statistical Analysis Plan (SAP)

Learn more about this trial

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

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

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial