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

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: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: BD MDI 320 µg; Drug: BD MDI 160 µg; Drug: BD MDI 80 µg; Drug: BD MDI 40 µg; Drug: Placebo MDI

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: Interventional
• Enrollment (Actual): 147
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	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

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)	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)	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	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	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

• Sponsor: Pearl Therapeutics, Inc.
• Investigators: Study Director: Paul Dorinsky, MD, FCCP, Pearl Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 4, 2015

Study Registration Dates

• First Submitted: April 2, 2014
• First Submitted That Met QC Criteria: April 4, 2014
• First Posted (Estimate): April 7, 2014

Study Record Updates

• Last Update Posted (Actual): June 6, 2017
• Last Update Submitted That Met QC Criteria: May 5, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Adult; Mild; moderate persistent
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID 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