Overview

This trial is active, not recruiting.

Condition asthma
Treatments budesonide inhalation aerosol (bd mdi; pt008) dose 1, budesonide inhalation aerosol (bd; pt008) dose 2, budesonide inhalation aerosol (bd mdi; pt008) dose 3, budesonide inhalation aerosol (bd mdi: pt008) dose 4, placebo mdi
Phase phase 2
Sponsor Pearl Therapeutics, Inc.
Start date April 2014
End date September 2015
Trial size 150 participants
Trial identifier NCT02105012, PT008001

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
BD MDI (PT008) administered as 2 inhalations BID
budesonide inhalation aerosol (bd mdi; pt008) dose 1
Budesonide Inhalation Aerosol (BD MDI; PT008) administered as 2 inhalations BID
(Experimental)
BD MDI (PT008) administered as 2 inhalations BID
budesonide inhalation aerosol (bd; pt008) dose 2
Budesonide Inhalation Aerosol (BD MDI; PT008) administered as 2 inhalations BID
(Experimental)
BD MDI (PT008) administered as 2 inhalations BID
budesonide inhalation aerosol (bd mdi; pt008) dose 3
Budesonide Inhalation Aerosol (BD MDI; PT008) administered as 2 inhalations BID
(Experimental)
BD MDI (PT008) administered as 2 inhalations BID
budesonide inhalation aerosol (bd mdi: pt008) dose 4
Budesonide Inhalation Aerosol (BD MDI: PT008) administered as 2 inhalations BID
(Placebo Comparator)
Placebo MDI administered as 2 inhalations BID
placebo mdi
Placebo MDI administered as 2 inhalations BID

Primary Outcomes

Measure
Change from baseline in morning pre-dose trough forced expiratory volume in one second (FEV1)
time frame: 28 Days

Secondary Outcomes

Measure
Change from baseline in mean morning pre-dose and mean evening pre-dose peak flow rate (PEFR)
time frame: 28 Days
Change from baseline in the mean number of puffs of rescue Ventolin hydrofluoroalkane (HFA)
time frame: 28 Days
Change from baseline in Asthma Control Questionnaire (ACQ) score
time frame: 28 Days

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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)

Additional Information

Official title A 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
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Pearl Therapeutics, Inc..