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

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ClinicalTrials.gov Identifier: NCT03769090
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Bond Avillion 2 Development LP

Brief Summary:
This is a randomized, double-blind, multicenter, parallel-group, variable-length study to compare 2 doses of BDA MDI (PT027) with AS MDI (PT007) on the time to first severe asthma exacerbation in adult, adolescent, and pediatric subjects with moderate to severe asthma.

Condition or disease Intervention/treatment Phase
Asthma Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg Combination Product: Albuterol sulfate metered-dose inhaler 180 μg Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Long-term, Randomized, Double-blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older With Asthma
Actual Study Start Date : December 27, 2018
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: BDA MDI (PT027) 80/180 μg
BDA MDI (PT027) low dose
Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg
Budesonide/albuterol sulfate combination inhalation aerosol

Experimental: BDA MDI (PT027) 160/180 μg
BDA MDI (PT027) high dose
Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg
Budesonide/albuterol sulfate combination inhalation aerosol

Active Comparator: AS MDI (PT007) 90 µg Combination Product: Albuterol sulfate metered-dose inhaler 180 μg
Albuterol sulfate inhalation aerosol




Primary Outcome Measures :
  1. Time to first severe asthma exacerbation [ Time Frame: until 570 total first severe asthma exacerbation events have occurred and all subjects have been assessed for at least 24 weeks after starting treatment ]
    Time to first severe asthma exacerbation will be calculated as the time from randomization until the start date of the first severe asthma exacerbation. An asthma exacerbation will be considered severe if it results in at least 1 of the following: a temporary bolus/burst of systemic corticosteroids for at least 3 consecutive days to treat symptoms of asthma worsening (a single depo-injectable dose of corticosteroids will be considered equivalent), an emergency room or urgent care visit (< 24 hours in the facility for evaluation and treatment) due to asthma that required systemic corticosteroids, or an in-patient hospitalization (admission to an in-patient facility and/or ≥ 24 hours in a healthcare facility) due to asthma.


Secondary Outcome Measures :
  1. Severe exacerbation rate (annualized) [ Time Frame: until 570 total first severe asthma exacerbation events have occurred and all subjects have been assessed for at least 24 weeks after starting treatment ]
    The annualized exacerbation rate is based on exacerbations reported in the Asthma Exacerbation eCRF

  2. Total corticosteroid exposure over the treatment period [ Time Frame: until 570 total first severe asthma exacerbation events have occurred and all subjects have been assessed for at least 24 weeks after starting treatment ]
    Total corticosteroid exposure reported as the mean daily dose will be calculated for each subject as the sum of the cumulative doses of maintenance inhaled corticosteroids, reliever inhaled corticosteroids, prescribed inhaled corticosteroids, and systemic corticosteroids divided by the number of days the subject was in the study prior to treatment discontinuation.

  3. Asthma Control Questionnaire-5 (ACQ-5) change from baseline at Week 24 [ Time Frame: 24 weeks ]
    Change from baseline in ACQ-5 as compared to albuterol sulfate at Week 24. The ACQ-5 consists of 5 questions on symptom control, with each scored on a 7-point scale (0 = excellent asthma control; 6 = extremely poor control). The overall score (0 = excellent asthma control; 6 = extremely poor control) is the mean of the 5 symptom items.

  4. Asthma Control Questionnaire-5 (ACQ-5) responder analysis at Week 24 [ Time Frame: 24 weeks ]
    ACQ-5 responders as compared to albuterol sulfate at Week 24. ACQ-5 responders are defined as subjects achieving a decline from baseline of at least 0.5 on the ACQ-5.

  5. Asthma Quality of Life Questionnaire (AQLQ) for 12 years and older/Pediatric Asthma Quality of Life Questionnaire (PAQLQ) change from baseline at Week 24 [ Time Frame: 24 weeks ]
    AQLQ consists of 32 questions in 4 domains and PAQLQ consists of 23 questions in 3 domains. Both are assessed on separate 7-point Likert scales from 1 to 7, with higher values indicating better health-related quality of life. The overall score is the mean of all responses. As the PAQLQ is not validated for children less than 7 years of age, data for subjects who are aged 4 to 6 years will be excluded from the analyses of PAQLQ endpoints.

  6. Asthma Quality of Life Questionnaire (AQLQ) for 12 years and older/Pediatric Asthma Quality of Life Questionnaire (PAQLQ) responder analysis at Week 24 [ Time Frame: 24 weeks ]
    Responders at Week 24 are defined as subjects achieving an increase from baseline of at least 0.5 on the AQLQ or PAQLQ



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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female or male aged ≥4 years at the time of informed consent
  2. Physician diagnosis of asthma documented for at least 1 year
  3. Receiving 1 of the following scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1:

    • Medium-to-high-dose inhaled corticosteroid (ICS)
    • Medium-to-high-dose ICS and 1 additional maintenance therapy from the following: leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA), or theophylline
    • Low-to-high-dose ICS in combination with long-acting β2-adrenoreceptor agonist (LABA) with or without one additional maintenance therapy from the following: LTRA, LAMA, or theophylline
  4. Prebronchodilator forced expiratory volume in 1 second (FEV1) of ≥40 to <90% predicted normal value for adults and adolescents, and ≥60 to <100% predicted normal value for subjects aged 4 to 11 years after withholding specified medications including short/rapid-acting β2-adrenoreceptor agonist (SABA)
  5. Demonstrate reversibility at Visit 1, with an increase in FEV1 ≥12% (and ≥200 mL for subjects aged ≥18 years) relative to baseline after administration of sponsor provided Ventolin via central spirometry. One re-test for reversibility testing is allowed within the screening period in advance of Visit 2
  6. Demonstrate acceptable spirometry performance (i.e., meet American Thoracic Society/European Respiratory Society acceptability/repeatability criteria)
  7. A documented history of at least 1 severe asthma exacerbation within 12 months before Visit 1
  8. Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as assessed by the investigator

Exclusion Criteria:

  1. Chronic obstructive pulmonary disease or other significant lung disease (e.g., chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
  2. Oral corticosteroid/SCS use (any dose and any indication) within 6 weeks before Visit 1
  3. Chronic use of oral corticosteroids (OCS, ≥3 weeks use in 3 months prior to Visit 1)
  4. Having received any marketed (e.g., omalizumab, mepolizumab, reslizumab, benralizumab) or investigational biologic within 3 months 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 intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within 5 years of Visit 1
  7. Historical or current evidence of a clinically significant disease
  8. Cancer not in complete remission for at least 5 years
  9. Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1
  10. History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity
  11. Significant abuse of alcohol or drugs

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): NCT03769090


Contacts
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Contact: Piotr Bernat, PharmD 48 22 219 5184 piotr.bernat@syneoshealth.com

Locations
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United States, Florida
Research Site Recruiting
Hialeah, Florida, United States, 33012
Research Site Recruiting
Miami, Florida, United States, 33135
Research Site Recruiting
Orlando, Florida, United States, 32819
Research Site Recruiting
Pembroke Pines, Florida, United States, 33024
United States, Massachusetts
Research Site Recruiting
North Dartmouth, Massachusetts, United States, 02747
United States, Michigan
Research Site Recruiting
Ypsilanti, Michigan, United States, 48197
United States, North Carolina
Research Site Recruiting
High Point, North Carolina, United States, 27262
United States, Oklahoma
Research Site Recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Research Site Recruiting
Medford, Oregon, United States, 97504
United States, Rhode Island
Research Site Recruiting
Warwick, Rhode Island, United States, 02886
Sponsors and Collaborators
Bond Avillion 2 Development LP

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Responsible Party: Bond Avillion 2 Development LP
ClinicalTrials.gov Identifier: NCT03769090     History of Changes
Other Study ID Numbers: AV003
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Asthma
Anti-Asthmatic Agents
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Albuterol
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action