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A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma (DENALI)

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ClinicalTrials.gov Identifier: NCT03847896
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : November 28, 2019
Sponsor:
Information provided by (Responsible Party):
Bond Avillion 2 Development LP

Tracking Information
First Submitted Date  ICMJE February 14, 2019
First Posted Date  ICMJE February 20, 2019
Last Update Posted Date November 28, 2019
Actual Study Start Date  ICMJE April 10, 2019
Estimated Primary Completion Date May 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
  • Change from baseline in forced expiratory volume in 1 second (FEV1) area under the concentration curve from 0 to 6 hours (AUC0-6 hours) over 12 weeks [ Time Frame: 12 weeks ]
    Lung function will be measured by spirometry. Baseline FEV1 will be taken as the average of the 60- and 30-minute pre-dose spirometry measures on or before randomization. Starting with the first study drug dose (Week 0) and then at Weeks 1, 4, 8, and 12, spirometry assessments will be completed at 60 and 30 minutes before the morning dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes after dosing. FEV1 AUC0-6 hours will be calculated for changes from baseline (randomization visit) using the trapezoidal rule and will be normalized by dividing by the time (in hours) from dosing to the last measurement included (typically 6 hours).
  • Change from baseline in trough FEV1 [ Time Frame: 12 weeks ]
    Baseline FEV1 will be taken as the average of the 60- and 30-minute pre-dose spirometry measures on or before randomization. Trough FEV1 will be taken as the average of the 60- and 30-minute pre-dose spirometry measures prior to dosing of study drug. In subjects with only 1 pre-dose assessment for trough, the value will be calculated from the single measurement.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03847896 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
  • The time to onset (defined as 15% increase in FEV1 over the pre-treatment value on Day 1) [ Time Frame: up to 30 minutes from first dose ]
    Time to onset (minutes) on Day 1 will be calculated as the time from dosing on Day 1 (randomization day) to the first instance within 30 minutes in which a percentage change from baseline in FEV1 greater or equal to 15% is observed
  • Duration of response on Day 1 [ Time Frame: Day 1 ]
    The duration of response is defined as the time from onset of at least a 15% increase in FEV1 to the offset of the 15% increase in FEV1 relative to baseline
  • Number (%) of subjects who have an Asthma Control Questionnaire-7 (ACQ-7) score of ≥ 1.5 at baseline who achieve a clinically meaningful improvement (a decrease of at least 0.5 units from baseline) in ACQ-7 at Week 12 [ Time Frame: 12 weeks ]
    The ACQ-7 consists of 7 questions on symptom control, with each scored on a 7-point scale (0 = good control; 6 = poor control). The overall score (0 = good control; 6 = poor control) is the mean of the 7 symptom items.
  • Trough FEV1 at Week 1 [ Time Frame: 1 week ]
    Trough FEV1 will be taken as the average of the 60- and 30-minute pre-dose spirometry measures prior to dosing of study drug. In subjects with only 1 pre-dose assessment for trough, the value will be calculated from the single measurement.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma
Official Title  ICMJE A 12-week, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT008 and PT007 Administered QID in Adults and Children 4 Years of Age or Older With Asthma
Brief Summary This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study to compare 2 dose levels of BDA MDI (PT027) to its components BD MDI (PT008) and AS MDI (PT007) on improvement in lung function and asthma symptoms after 12 weeks of treatment in adult, adolescent, and child subjects with symptomatic asthma currently being treated with a short/rapid-acting β2-adrenoreceptor agonist (SABA; eg, Ventolin) as needed alone or with low-dose inhaled corticosteroid (ICS) maintenance therapy plus SABA as needed.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg
    Budesonide/albuterol sulfate combination inhalation aerosol
  • Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg
    Budesonide/albuterol sulfate combination inhalation aerosol
  • Combination Product: Budesonide metered-dose inhaler 160 µg
    Budesonide inhalation aerosol
  • Combination Product: Albuterol sulfate metered-dose inhaler 180 μg
    Albuterol sulfate inhalation aerosol
  • Combination Product: Placebo metered-dose inhaler
    Placebo inhalation aerosol administered 4 times daily
Study Arms  ICMJE
  • Experimental: BDA MDI (PT027) 80/180 μg
    BDA MDI (PT027) low dose
    Intervention: Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg
  • Experimental: BDA MDI (PT027) 160/180 μg
    BDA MDI (PT027) high dose
    Intervention: Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg
  • Active Comparator: BD MDI (PT008) 160 µg
    Intervention: Combination Product: Budesonide metered-dose inhaler 160 µg
  • Active Comparator: AS MDI (PT007) 180 µg
    Intervention: Combination Product: Albuterol sulfate metered-dose inhaler 180 μg
  • Placebo Comparator: Placebo MDI
    Intervention: Combination Product: Placebo metered-dose inhaler
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 19, 2019)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 11, 2020
Estimated Primary Completion Date May 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female or male aged ≥4 years at the time of informed consent
  2. Physician diagnosis of asthma with a documented history of the last 6 months
  3. Receiving 1 of the following inhaled asthma medications with stable dosing for at least 30 days prior to Visit 1:

    • Only short/rapid-acting β2-adrenoreceptor agonist (SABA) used as needed
    • Stable low-dose inhaled corticosteroid in addition to as-needed use of SABA
  4. Pre-bronchodilator FEV1 of ≥50 to <85% predicted normal value for adults (≥18 years of age) and ≥50 to <90% predicted normal value for subjects aged 4 to 17 years after withholding SABA ≥6 hours at Visit 1.
  5. Demonstrate reversibility of airflow limitation defined as a ≥15% increase in FEV1 relative to baseline after administration of Sponsor-provided SABA (Ventolin) at either Visit 1 or Visit 1a.
  6. Demonstrate acceptable spirometry performance acceptability/repeatability criteria
  7. Taken Ventolin on ≥2 days out of 7 days prior to Visit 2
  8. Demonstrate acceptable MDI administration technique as assessed by the investigator.
  9. Able to perform acceptable and reproducible peak expiratory flow measurements as assessed by the investigator

Exclusion Criteria:

  1. Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
  2. Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months before Visit 1
  3. Chronic (≥3 weeks) use of SCS within 6 months prior to Visit 1
  4. Received any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab) or investigational biologic within 3 months or 5 half-lives before Visit 1, whichever is longer, or any other prohibited medication
  5. Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months before Visit 1 (including all forms of tobacco, e-cigarettes [vaping], and marijuana)
  6. Life-threatening asthma defined as any history of significant asthma episode(s) requiring admission to an intensive care unit, intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within 5 years of Visit 1
  7. Completed treatment for lower respiratory infection within 6 weeks prior to Visit 1
  8. Upper respiratory infection involving antibiotic treatment not resolved within 7 days prior to Visit 1
  9. Hospitalizations due to asthma within 6 months prior to Visit 1
  10. Have taken ≥12 actuations per day of Sponsor-provided Ventolin during the run-in period prior to Visit 2 according to the below criteria:

    • ≥2 days out of 14 days of run-in
    • ≥3 days out of 15 to 21 days of run-in
    • ≥4 days out of 22 or more days of run-in
  11. Unable to comply with study procedures including non-compliance with diary completion (ie, <70% subject completion of diary assessments in the last 7 days preceding Visit 2 or 4-times daily dosing, <80% compliance during the placebo run-in period).
  12. Historical or current evidence of a clinically significant disease
  13. Cancer not in complete remission for at least 5 years before Visit 1
  14. Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1
  15. History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity
  16. Significant abuse of alcohol or drugs, in the opinion of the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Piotr Bernat, PharmD 48 22 219 5184 piotr.bernat@syneoshealth.com
Listed Location Countries  ICMJE Argentina,   Czechia,   Germany,   Serbia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03847896
Other Study ID Numbers  ICMJE AV004
2018-003674-27 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bond Avillion 2 Development LP
Study Sponsor  ICMJE Bond Avillion 2 Development LP
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bond Avillion 2 Development LP
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP