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

NCT02105012 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PT008001
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 41

Brief Summary

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.

Conditions

Asthma

Keywords

Mild; moderate persistent; Adult

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

  Baseline to Last 7 Days of Treatment Period

• 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

  Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)

Study Arms (5)

BD MDI 320 µg

EXPERIMENTAL

Budesonide metered dose inhaler (BD MDI) 320 µg (PT008) administered as 2 inhalations BID

Drug: BD MDI 320 µg

BD MDI 160 µg

EXPERIMENTAL

BD MDI 160 µg (PT008) administered as 2 inhalations BID

Drug: BD MDI 160 µg

BD MDI 80 µg

EXPERIMENTAL

BD MDI 80 µg (PT008) administered as 2 inhalations BID

Drug: BD MDI 80 µg

BD MDI 40 µg

EXPERIMENTAL

BD MDI 40 µg (PT008) administered as 2 inhalations BID

Drug: BD MDI 40 µg

Placebo MDI

PLACEBO COMPARATOR

Placebo MDI administered as 2 inhalations BID

Drug: Placebo MDI

Interventions

BD MDI 320 µg DRUG

Budesonide Inhalation Aerosol administered as 2 inhalations BID

Also known as: PT008

BD MDI 320 µg

BD MDI 160 µg DRUG

Budesonide Inhalation Aerosol administered as 2 inhalations BID

Also known as: PT008

BD MDI 160 µg

BD MDI 80 µg DRUG

Budesonide Inhalation Aerosol administered as 2 inhalations BID

Also known as: PT008

BD MDI 80 µg

BD MDI 40 µg DRUG

Budesonide Inhalation Aerosol administered as 2 inhalations BID

Also known as: PT008

BD MDI 40 µg

Placebo MDI DRUG

Placebo MDI administered as 2 inhalations BID

Placebo MDI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Study Sites (41)

Pearl Therapeutics Study Site

Athens, Alabama, United States

Location

Pearl Therapeutics Study Site

Birmingham, Alabama, United States

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Pearl Therapeutics Study Site

Foley, Alabama, United States

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Pearl Therapeutics Study Site

Los Angeles, California, United States

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Pearl Therapeutics

Los Angeles, California, United States

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Pearl Therapeutics Study Site

Rolling Hills Estates, California, United States

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Pearl Therapeutics Study Site

San Diego, California, United States

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Pearl Therapeutics Study Site

Stockton, California, United States

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Pearl Therapeutics Study Site

Clearwater, Florida, United States

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Pearl Therapeutics Study Site

Clermont, Florida, United States

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Pearl Therapeutics Study Site

Miami, Florida, United States

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Pearl Therapeutics Study Site

Orlando, Florida, United States

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Pearl Therapeutics Study Site

Ormond Beach, Florida, United States

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Pearl Therapeutics Study Site

Saint Cloud, Florida, United States

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Pearl Therapeutics Study Site

Sebring, Florida, United States

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Pearl Therapeutics Study Site

Tampa, Florida, United States

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Pearl Therapeutics Study Site

Blue Island, Illinois, United States

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Pearl Therapeutics Study Site

North Dartmouth, Massachusetts, United States

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Pearl Therapeutics Study Site

Hazelwood, Missouri, United States

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Pearl Therapeutics Study Site

Skillman, New Jersey, United States

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Pearl Therapeutics Study Site

Charlotte, North Carolina, United States

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Pearl Therapeutics Study Site

Winston-Salem, North Carolina, United States

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Pearl Therapeutics Study Site

Cincinnati, Ohio, United States

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Pearl Therapeutics Study Site

Columbus, Ohio, United States

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Pearl Therapeutics Study Site

Dayton, Ohio, United States

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Pearl Therapeutics Study Site

Middleburg Heights, Ohio, United States

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Pearl Therapeutics Study Site

Oregon, Ohio, United States

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Pearl Therapeutics Study Site

Sylvania, Ohio, United States

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Pearl Therapeutics Study Site

Toledo, Ohio, United States

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Pearl Therapeutics Study Site

Oklahoma City, Oklahoma, United States

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Pearl Therapeutics Study Site

Lake Oswego, Oregon, United States

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Pearl Therapeutics Study Site

Medford, Oregon, United States

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Pearl Therapeutics Study Site

Greenville, South Carolina, United States

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Pearl Therapeutics Study Site

Spartanburg, South Carolina, United States

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Pearl Therapeutics Study Site

Rapid City, South Dakota, United States

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Pearl Therapeutics Study Site

Tullahoma, Tennessee, United States

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Pearl Therapeutics Study Site

El Paso, Texas, United States

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Pearl Therapeutics Study Site

Houston, Texas, United States

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Pearl Therapeutics Study Site

Plano, Texas, United States

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Pearl Therapeutics Study Site

San Antonio, Texas, United States

Location

Pearl Therapeutics Study Site

Everett, Washington, United States

Location

MeSH Terms

Conditions

Asthma; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders

Results Point of Contact

• Title: Paul Dorinsky, MD, FCCP
• Organization: Pearl Therapeutics Inc.

pdorinsky@pearltherapeutics.com

650-305-2600

Study Officials

• Paul Dorinsky, MD, FCCP

  Pearl Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 7, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 4, 2015
• Last Updated: June 6, 2017
• Results First Posted: June 6, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

US (41)