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

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



Sponsors

Lead Sponsor



Source

AstraZeneca

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

Yes

Is Fda Regulated Device

No

Is Us Export

Yes


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.

Overall Status

Recruiting

Start Date

2017-12-06

Completion Date

2018-05-09

Primary Completion Date

2018-05-09

Phase

Phase 2

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Change from baseline in FEV1 AUC0-6
1 Day

Secondary Outcome

Measure

Time Frame

Change from baseline in FEV1 AUC0-4
1 Day
Peak change from baseline in FEV1
1 Day

Enrollment

70

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

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

Arm Group Label

• AS MDI 90 µg

Other Name

AS MDI


Intervention Type

Drug

Intervention Name


Description

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

Arm Group Label

• AS MDI 180 µg

Other Name

AS MDI


Intervention Type

Other

Intervention Name


Description

Placebo MDI (2 actuations)

Arm Group Label

• Placebo MDI


Intervention Type

Drug

Intervention Name


Description

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

Arm Group Label

• Proventil 90 µg

Other Name

Proventil


Intervention Type

Drug

Intervention Name


Description

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

Arm Group Label

• Proventil 180 µg

Other Name

Proventil



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

Gender

All

Minimum Age

12 Years

Maximum Age

65 Years

Healthy Volunteers

No


Overall Contact

Last Name

AstraZeneca Clinical Study Information Center

Phone

1-877-240-9479

Email



Location

Facility

Status

Research Site
Rolling Hills Estates California 90274 United States
Recruiting
Research Site
Stockton California 95207 United States
Recruiting
Research Site
Winter Park Florida 32789 United States
Recruiting
Research Site
North Dartmouth Massachusetts 02747 United States
Recruiting
Research Site
Saint Louis Missouri 63141 United States
Recruiting
Research Site
Raleigh North Carolina 27607 United States
Recruiting
Research Site
Cincinnati Ohio 45242 United States
Recruiting
Research Site
Medford Oregon 97504 United States
Recruiting
Research Site
Spartanburg South Carolina 29303 United States
Recruiting
Research Site
El Paso Texas 79903 United States
Recruiting

Location Countries

Country

United States


Verification Date

2017-12-01

Lastchanged Date

2017-12-12

Firstreceived Date

2017-12-01

Responsible Party

Responsible Party Type

Sponsor


Condition Browse


Number Of Arms

5

Intervention Browse

Mesh Term

Albuterol


Arm Group

Arm Group Label

• AS MDI 90 µg

Arm Group Type

Experimental

Description

(2 actuations of 45 µg/actuation)


Arm Group Label

• AS MDI 180 µg

Arm Group Type

Experimental

Description

(2 actuations of 90 µg/actuation)


Arm Group Label

• Placebo MDI

Arm Group Type

Placebo Comparator

Description

(2 actuations)


Arm Group Label

• Proventil 90 µg

Arm Group Type

Active Comparator

Description

(1 actuation of 90 µg/actuation)


Arm Group Label

• Proventil 180 µg

Arm Group Type

Active Comparator

Description

(2 actuations of 90 µg/actuation)



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Crossover Assignment

Primary Purpose

Treatment

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)


Study First Submitted

December 1, 2017

Study First Submitted Qc

December 1, 2017

Study First Posted

December 6, 2017

Last Update Submitted

December 12, 2017

Last Update Submitted Qc

December 12, 2017

Last Update Posted

December 14, 2017


ClinicalTrials.gov processed this data on December 14, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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