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

Study identifier:PT008001

ClinicalTrials.gov identifier:NCT02105012

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

asthma

Phase

Phase 2

Healthy volunteers

Study drug

BD MDI 320 µg, BD MDI 160 µg, BD MDI 80 µg, BD MDI 40 µg, Placebo MDI

Sex

All

Actual Enrollment

147

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Apr 2014

Primary Completion Date: 01 Sept 2015

Study Completion Date: 04 Sept 2015

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2019 by Pearl Therapeutics, Inc.

Collaborators

Inclusion and exclusion 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)

No locations available

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

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4143&filename=PT008001-protocol_REDACTED_15MARCH2018.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Lori Faria

862-777-8047

[email protected]

Investigators

Principal Investigator

Paul Dorinsky

Pearl Therapeutics, Inc.