Clinical trial NCT02105012: Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Mild
moderate persistent
Adult
Lead sponsor: Pearl Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-07
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) at the End of the Treatment Period
timeFrame: Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)
Secondary outcomes:
measure: Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
timeFrame: Baseline to Last 7 Days of Treatment Period
measure: Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
timeFrame: Baseline to Last 7 Days of Treatment Period
measure: Change From Baseline in Mean Number of Puffs of Rescue Ventolin HFA
timeFrame: Baseline to Last 7 Days of Treatment
measure: Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score
timeFrame: Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)
Other outcomes:
Locations:
city: Athens
country: United States
facility: Pearl Therapeutics Study Site
state: Alabama
city: Birmingham
country: United States
facility: Pearl Therapeutics Study Site
state: Alabama
city: Foley
country: United States
facility: Pearl Therapeutics Study Site
state: Alabama
city: Los Angeles
country: United States
facility: Pearl Therapeutics Study Site
state: California
city: Los Angeles
country: United States
facility: Pearl Therapeutics
state: California
city: Rolling Hills Estates
country: United States
facility: Pearl Therapeutics Study Site
state: California
city: San Diego
country: United States
facility: Pearl Therapeutics Study Site
state: California
city: Stockton
country: United States
facility: Pearl Therapeutics Study Site
state: California
city: Clearwater
country: United States
facility: Pearl Therapeutics Study Site
state: Florida
city: Clermont
country: United States
facility: Pearl Therapeutics Study Site
state: Florida
city: Miami
country: United States
facility: Pearl Therapeutics Study Site
state: Florida
city: Orlando
country: United States
facility: Pearl Therapeutics Study Site
state: Florida
city: Ormond Beach
country: United States
facility: Pearl Therapeutics Study Site
state: Florida
city: Saint Cloud
country: United States
facility: Pearl Therapeutics Study Site
state: Florida
city: Sebring
country: United States
facility: Pearl Therapeutics Study Site
state: Florida
city: Tampa
country: United States
facility: Pearl Therapeutics Study Site
state: Florida
city: Blue Island
country: United States
facility: Pearl Therapeutics Study Site
state: Illinois
city: North Dartmouth
country: United States
facility: Pearl Therapeutics Study Site
state: Massachusetts
city: Hazelwood
country: United States
facility: Pearl Therapeutics Study Site
state: Missouri
city: Skillman
country: United States
facility: Pearl Therapeutics Study Site
state: New Jersey
city: Charlotte
country: United States
facility: Pearl Therapeutics Study Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pearl Therapeutics Study Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pearl Therapeutics Study Site
state: Ohio
city: Columbus
country: United States
facility: Pearl Therapeutics Study Site
state: Ohio
city: Dayton
country: United States
facility: Pearl Therapeutics Study Site
state: Ohio
city: Middleburg Heights
country: United States
facility: Pearl Therapeutics Study Site
state: Ohio
city: Oregon
country: United States
facility: Pearl Therapeutics Study Site
state: Ohio
city: Sylvania
country: United States
facility: Pearl Therapeutics Study Site
state: Ohio
city: Toledo
country: United States
facility: Pearl Therapeutics Study Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pearl Therapeutics Study Site
state: Oklahoma
city: Lake Oswego
country: United States
facility: Pearl Therapeutics Study Site
state: Oregon
city: Medford
country: United States
facility: Pearl Therapeutics Study Site
state: Oregon
city: Greenville
country: United States
facility: Pearl Therapeutics Study Site
state: South Carolina
city: Spartanburg
country: United States
facility: Pearl Therapeutics Study Site
state: South Carolina
city: Rapid City
country: United States
facility: Pearl Therapeutics Study Site
state: South Dakota
city: Tullahoma
country: United States
facility: Pearl Therapeutics Study Site
state: Tennessee
city: El Paso
country: United States
facility: Pearl Therapeutics Study Site
state: Texas
city: Houston
country: United States
facility: Pearl Therapeutics Study Site
state: Texas
city: Plano
country: United States
facility: Pearl Therapeutics Study Site
state: Texas
city: San Antonio
country: United States
facility: Pearl Therapeutics Study Site
state: Texas
city: Everett
country: United States
facility: Pearl Therapeutics Study Site
state: Washington
Study officials:
affiliation: Pearl Therapeutics, Inc.
name: Paul Dorinsky, MD, FCCP
role: STUDY_DIRECTOR
References: