Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma

May 5, 2017 updated by: Pearl Therapeutics, Inc.

Randomized, Double-Blind, Chronic Dosing (4 Weeks), Four-Period, Five-Treatment, Incomplete Block, Cross-Over, Multi-Center Study to Assess the Efficacy and Safety of Four Doses of Budesonide Inhalation Aerosol (BD MDI, PT008) Relative to Placebo MDI in Adult Subjects With Mild to Moderate Persistent Asthma

Study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (BD MDI, PT008) relative to placebo MDI in adult subjects with mild to moderate persistent asthma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized, double-blind, chronic dosing (4 weeks), four-period, five-treatment, incomplete block, cross-over, multicenter study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (BD MDI, PT008) relative to placebo MDI in adult subjects with mild to moderate persistent asthma.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
147

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Athens, Alabama, United States
        • Pearl Therapeutics Study Site
      • Birmingham, Alabama, United States
        • Pearl Therapeutics Study Site
      • Foley, Alabama, United States
        • Pearl Therapeutics Study Site
    • California
      • Los Angeles, California, United States
        • Pearl Therapeutics Study Site
      • Los Angeles, California, United States
        • Pearl Therapeutics
      • Rolling Hills Estates, California, United States
        • Pearl Therapeutics Study Site
      • San Diego, California, United States
        • Pearl Therapeutics Study Site
      • Stockton, California, United States
        • Pearl Therapeutics Study Site
    • Florida
      • Clearwater, Florida, United States
        • Pearl Therapeutics Study Site
      • Clermont, Florida, United States
        • Pearl Therapeutics Study Site
      • Miami, Florida, United States
        • Pearl Therapeutics Study Site
      • Orlando, Florida, United States
        • Pearl Therapeutics Study Site
      • Ormond Beach, Florida, United States
        • Pearl Therapeutics Study Site
      • Saint Cloud, Florida, United States
        • Pearl Therapeutics Study Site
      • Sebring, Florida, United States
        • Pearl Therapeutics Study Site
      • Tampa, Florida, United States
        • Pearl Therapeutics Study Site
    • Illinois
      • Blue Island, Illinois, United States
        • Pearl Therapeutics Study Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States
        • Pearl Therapeutics Study Site
    • Missouri
      • Hazelwood, Missouri, United States
        • Pearl Therapeutics Study Site
    • New Jersey
      • Skillman, New Jersey, United States
        • Pearl Therapeutics Study Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Pearl Therapeutics Study Site
      • Winston-Salem, North Carolina, United States
        • Pearl Therapeutics Study Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Pearl Therapeutics Study Site
      • Columbus, Ohio, United States
        • Pearl Therapeutics Study Site
      • Dayton, Ohio, United States
        • Pearl Therapeutics Study Site
      • Middleburg Heights, Ohio, United States
        • Pearl Therapeutics Study Site
      • Oregon, Ohio, United States
        • Pearl Therapeutics Study Site
      • Sylvania, Ohio, United States
        • Pearl Therapeutics Study Site
      • Toledo, Ohio, United States
        • Pearl Therapeutics Study Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Pearl Therapeutics Study Site
    • Oregon
      • Lake Oswego, Oregon, United States
        • Pearl Therapeutics Study Site
      • Medford, Oregon, United States
        • Pearl Therapeutics Study Site
    • South Carolina
      • Greenville, South Carolina, United States
        • Pearl Therapeutics Study Site
      • Spartanburg, South Carolina, United States
        • Pearl Therapeutics Study Site
    • South Dakota
      • Rapid City, South Dakota, United States
        • Pearl Therapeutics Study Site
    • Tennessee
      • Tullahoma, Tennessee, United States
        • Pearl Therapeutics Study Site
    • Texas
      • El Paso, Texas, United States
        • Pearl Therapeutics Study Site
      • Houston, Texas, United States
        • Pearl Therapeutics Study Site
      • Plano, Texas, United States
        • Pearl Therapeutics Study Site
      • San Antonio, Texas, United States
        • Pearl Therapeutics Study Site
    • Washington
      • Everett, Washington, United States
        • Pearl Therapeutics Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥ 18 - 65 years of age
  • Diagnosis of mild to moderate persistent asthma, diagnosed at least 6 months prior to screening
  • Currently receiving treatment with a low to medium dose of an inhaled corticosteroid (ICS) OR a combination of controller medications for at least 4 weeks preceding screening
  • Pre-albuterol FEV1 of > 60% and < 85% of predicted normal value
  • Reversibility: Increase in FEV1 of ≥ 12% and ≥ 200 mL over the pre-albuterol FEV1 within 30 - 60 minutes after the inhalation of 4 puffs of Ventolin hydrofluoroalkane (HFA)
  • Asthma Symptom Criteria: Have required albuterol use on at least two of the last seven days and have an Asthma Control Questionnaire (ACQ) total score ≥ 1.5 prior to Randomization

Exclusion Criteria:

  • Life-Threatening Asthma: A subject must not have life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within the 12 months prior to screening
  • Worsening of Asthma: A subject must not have experienced a worsening of asthma which involved an emergency department visit, hospitalization or use of oral/parenteral corticosteroids within 6 weeks of screening
  • Intermittent, Seasonal, or Exercise-Induced Asthma Alone: Subjects with only intermittent, seasonal or exercise-induced asthma are excluded from participation in this study
  • Concurrent Respiratory Disease
  • Pregnant women or nursing mothers
  • A current diagnosis of Chronic Obstructive Pulmonary Disease (COPD
  • Current smokers or subjects with a > 10 pack year history of cigarettes, cigars, or pipe smoking
  • Respiratory tract infection within 6 weeks prior to Visit 1
  • Subjects with documented myocardial infarction within a year from screening visit
  • Clinically significant abnormal ECG
  • Abnormal liver function tests defined as aspartate aminotransferase (AST), alanine aminotransferace (ALT), alkaline phosphatase or total bilirubin ≥ 1.5 times upper limit of normal on repeat testing
  • Subjects who have cancer that has not been in complete remission for at least 5 years
  • Drug Allergy: Subjects who have a history of hypersensitivity to any component of the metered-dose inhaler (MDI)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BD MDI 320 µg
Budesonide metered dose inhaler (BD MDI) 320 µg (PT008) administered as 2 inhalations BID
Drug: BD MDI 320 µg
Budesonide Inhalation Aerosol administered as 2 inhalations BID
Other Names:
  • PT008
Experimental: BD MDI 160 µg
BD MDI 160 µg (PT008) administered as 2 inhalations BID
Drug: BD MDI 160 µg
Budesonide Inhalation Aerosol administered as 2 inhalations BID
Other Names:
  • PT008
Experimental: BD MDI 80 µg
BD MDI 80 µg (PT008) administered as 2 inhalations BID
Drug: BD MDI 80 µg
Budesonide Inhalation Aerosol administered as 2 inhalations BID
Other Names:
  • PT008
Experimental: BD MDI 40 µg
BD MDI 40 µg (PT008) administered as 2 inhalations BID
Drug: BD MDI 40 µg
Budesonide Inhalation Aerosol administered as 2 inhalations BID
Other Names:
  • PT008
Placebo Comparator: Placebo MDI
Placebo MDI administered as 2 inhalations BID
Drug: Placebo MDI
Placebo MDI administered as 2 inhalations BID

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) at the End of the Treatment Period
Time Frame: Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)
Change from baseline in morning pre-dose trough Forced Expiratory Volume in 1 second (FEV1) at the end of the Treatment Period.
Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
Time Frame: Baseline to Last 7 Days of Treatment Period
Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
Baseline to Last 7 Days of Treatment Period
Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
Time Frame: Baseline to Last 7 Days of Treatment Period
Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
Baseline to Last 7 Days of Treatment Period
Change From Baseline in Mean Number of Puffs of Rescue Ventolin HFA
Time Frame: Baseline to Last 7 Days of Treatment
Change from baseline in mean number of puffs of rescue Ventolin HFA
Baseline to Last 7 Days of Treatment
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score
Time Frame: Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)
The ACQ-5 measures 5 symptoms (woken at night by symptoms, wake in the morning with symptoms, limitation of daily activities, shortness of breath, and wheeze). The scale is 0-6, where 0=minimum and 6=maximum
Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pearl Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Paul Dorinsky, MD, FCCP, Pearl Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 4, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PT008001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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