Chronic Dosing, Cross-Over Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02105012
• Other study ID #: PT008001
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 2, 2014
• Last updated: February 17, 2016
• Start date: April 2014
• Est. completion date: March 2016

Study information

• Verified date: February 2016
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: March 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide Inhalation Aerosol (BD MDI; PT008) Dose 1
Budesonide Inhalation Aerosol (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
• Budesonide Inhalation Aerosol (BD MDI; PT008) Dose 3
Budesonide Inhalation Aerosol (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 MDI
Placebo MDI administered as 2 inhalations BID

Locations

Country	Name	City	State
United States	Pearl Therapeutics Study Site	Athens	Alabama
United States	Pearl Therapeutics Study Site	Birmingham	Alabama
United States	Pearl Therapeutics Study Site	Blue Island	Illinois
United States	Pearl Therapeutics Study Site	Charlotte	North Carolina
United States	Pearl Therapeutics Study Site	Cincinnati	Ohio
United States	Pearl Therapeutics Study Site	Clearwater	Florida
United States	Pearl Therapeutics Study Site	Clermont	Florida
United States	Pearl Therapeutics Study Site	Columbus	Ohio
United States	Pearl Therapeutics Study Site	Dayton	Ohio
United States	Pearl Therapeutics Study Site	El Paso	Texas
United States	Pearl Therapeutics Study Site	Everett	Washington
United States	Pearl Therapeutics Study Site	Foley	Alabama
United States	Pearl Therapeutics Study Site	Greenville	South Carolina
United States	Pearl Therapeutics Study Site	Hazelwood	Missouri
United States	Pearl Therapeutics Study Site	Houston	Texas
United States	Pearl Therapeutics Study Site	Lake Oswego	Oregon
United States	Pearl Therapeutics	Los Angeles	California
United States	Pearl Therapeutics Study Site	Los Angeles	California
United States	Pearl Therapeutics Study Site	Medford	Oregon
United States	Pearl Therapeutics Study Site	Miami	Florida
United States	Pearl Therapeutics Study Site	Middleburg Heights	Ohio
United States	Pearl Therapeutics Study Site	North Dartmouth	Massachusetts
United States	Pearl Therapeutics Study Site	Oklahoma City	Oklahoma
United States	Pearl Therapeutics Study Site	Oregon	Ohio
United States	Pearl Therapeutics Study Site	Orlando	Florida
United States	Pearl Therapeutics Study Site	Ormond Beach	Florida
United States	Pearl Therapeutics Study Site	Plano	Texas
United States	Pearl Therapeutics Study Site	Rapid CIty	South Dakota
United States	Pearl Therapeutics Study Site	Rolling Hills Estates	California
United States	Pearl Therapeutics Study Site	San Antonio	Texas
United States	Pearl Therapeutics Study Site	San Diego	California
United States	Pearl Therapeutics Study Site	Sebring	Florida
United States	Pearl Therapeutics Study Site	Skillman	New Jersey
United States	Pearl Therapeutics Study Site	Spartanburg	South Carolina
United States	Pearl Therapeutics Study Site	St Cloud	Florida
United States	Pearl Therapeutics Study Site	Stockton	California
United States	Pearl Therapeutics Study Site	Sylvania	Ohio
United States	Pearl Therapeutics Study Site	Tampa	Florida
United States	Pearl Therapeutics Study Site	Toledo	Ohio
United States	Pearl Therapeutics Study Site	Tullahoma	Tennessee
United States	Pearl Therapeutics Study Site	Winstom-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in morning pre-dose trough FEV1 over the Treatment Period and at Day 15 and Day 29 of the Treatment Period		28 Days	No
Other	Change from baseline in mean morning and evening pre- and post-dose daily PEFR		28 Days	No
Other	Change from baseline in the mean number of puffs of rescue Ventolin HFA		28 Days	No
Other	Percentage of days without rescue Ventolin HFA use		28 Days	No
Other	Change from baseline in pre-dose trough forced vital capacity (FVC)		28 Days	No
Other	Change from baseline in pre-dose trough PEFR		28 Days	No
Other	Change from baseline in pre-dose trough forced expiratory flow 25-75% (FEF25-75)		28 Days	No
Other	Change from baseline in the number of nighttime awakenings due to asthma symptoms		28 Days	No
Other	Percentage of nights with awakenings due to asthma symptoms		28 Days	No
Other	Safety	Safety assessments include ECGs, vital sign measurements, clinical laboratory tests, monitoring for paradoxical bronchospasm, physical examination findings, Adverse Events (AEs) and Serious Adverse Events (SAEs)	28 Days	Yes
Primary	Change from baseline in morning pre-dose trough forced expiratory volume in one second (FEV1)		28 Days	No
Secondary	Change from baseline in mean morning pre-dose and mean evening pre-dose peak flow rate (PEFR)		28 Days	No
Secondary	Change from baseline in the mean number of puffs of rescue Ventolin hydrofluoroalkane (HFA)		28 Days	No
Secondary	Change from baseline in Asthma Control Questionnaire (ACQ) score		28 Days	No