We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02105012
Recruitment Status : Completed
First Posted : April 7, 2014
Results First Posted : June 6, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment 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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (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
Actual Study Start Date : April 1, 2014
Primary Completion Date : September 1, 2015
Study Completion Date : September 4, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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)

  2. 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)

  3. 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

  4. 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


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: April 7, 2014    Key Record Dates
Results First Posted: June 6, 2017
Last Update Posted: June 6, 2017
Last Verified: May 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