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

Phase 2

Completed

Interventions: Drug: Placebo MDI
Drug: BD MDI 40 µg
Drug: BD MDI 320 µg
Drug: BD MDI 160 µg
Drug: BD MDI 80 µg

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Placebo MDI	Placebo MDI	Placebo MDI administered as 2 inhalations BID
BD MDI 40 µg	BD MDI 40 µg	BD MDI 40 µg (PT008) administered as 2 inhalations BID
BD MDI 320 µg	BD MDI 320 µg	Budesonide metered dose inhaler (BD MDI) 320 µg (PT008) administered as 2 inhalations BID
BD MDI 160 µg	BD MDI 160 µg	BD MDI 160 µg (PT008) administered as 2 inhalations BID
BD MDI 80 µg	BD MDI 80 µg	BD MDI 80 µg (PT008) administered as 2 inhalations BID

Primary Outcome Measures

Name	Time	Method
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)	Change from baseline in morning pre-dose trough Forced Expiratory Volume in 1 second (FEV1) at the end of the Treatment Period.

Secondary Outcome Measures

Name	Time	Method
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 Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
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)	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
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 Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
Change From Baseline in Mean Number of Puffs of Rescue Ventolin HFA	Baseline to Last 7 Days of Treatment	Change from baseline in mean number of puffs of rescue Ventolin HFA