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

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: BD MDI 320 µg Drug: BD MDI 160 µg Drug: BD MDI 80 µg Drug: BD MDI 40 µg Drug: Placebo MDI	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Participant, Investigator Masking Description: Double Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by Pearl Therapeutics, Inc.:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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)
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)
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
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


Enrollment:	147
Actual Study Start Date:	April 1, 2014
Study Completion Date:	September 4, 2015
Primary Completion Date:	September 1, 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: PT008
Placebo Comparator: Placebo MDI Placebo MDI administered as 2 inhalations BID	Drug: Placebo MDI Placebo MDI administered as 2 inhalations BID

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


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02105012

Show 41 Study Locations

Sponsors and Collaborators

Pearl Therapeutics, Inc.

Investigators


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

More Information


Responsible Party:	Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT02105012 History of Changes
Other Study ID Numbers:	PT008001
Study First Received:	April 2, 2014
Results First Received:	October 31, 2016
Last Updated:	May 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes


Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Pearl Therapeutics, Inc.:


Mild moderate persistent Adult

Additional relevant MeSH terms:


Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide	Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 17, 2017