AsthmaPhase 3MANDALANCT03769090

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

A Phase 3 study testing Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg, Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg and Albuterol sulfate metered-dose inhaler 180 μg in people with Asthma, run by Bond Avillion 2 Development LP at 345 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 4 years and older
Conditions the study is for: Asthma
What is being tested?: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg, Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg and Albuterol sulfate metered-dose inhaler 180 μg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,132 participants
Where: 345 sitesin 11 countries
Study dates: 13 Dec 2018to 7 Feb 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Female or male aged ≥4 years at the time of informed consent
Physician diagnosis of asthma documented for at least 1 year
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

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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)
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
Demonstrate acceptable spirometry performance (i.e., meet American Thoracic Society/European Respiratory Society acceptability/repeatability criteria)
A documented history of at least 1 severe asthma exacerbation within 12 months before Visit 1
Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as assessed by the investigator

Who cannot join

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)
Oral corticosteroid/SCS use (any dose and any indication) within 6 weeks before Visit 1
Chronic use of oral corticosteroids (OCS, ≥3 weeks use in 3 months prior to Visit 1)
Having received any marketed (e.g., omalizumab, mepolizumab, reslizumab, benralizumab) or investigational biologic within 3 months or any other prohibited medication
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)
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

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Historical or current evidence of a clinically significant disease
Cancer not in complete remission for at least 5 years
Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1
History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity
Significant abuse of alcohol or drugs

Trial locations and contacts

345 sites in 11 countries.

Country

City, postcode or hospital

345 sites in 11 countries

United States170 sites

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Albany, Georgia, 31707
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Albuquerque, New Mexico, 87131
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Anderson, South Carolina, 29621
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Ann Arbor, Michigan, 48106
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Ann Arbor, Michigan, 48109
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Asheville, North Carolina, 28801
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Aurora, Colorado, 80045
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Austin, Texas, 78726
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Austin, Texas, 78759
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Aventura, Florida, 33180
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Bakersfield, California, 93301
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Baltimore, Maryland, 21209
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Bangor, Maine, 04401
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Beaumont, Texas, 77702
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Bellevue, Nebraska, 68005
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Bellevue, Nebraska, 68123
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Bellflower, California, 90706
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Birmingham, Alabama, 35209
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Blue Bell, Pennsylvania, 19422
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Boerne, Texas, 78006
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Boston, Massachusetts, 02115
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Boynton Beach, Florida, 33436
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Brick, New Jersey, 08724
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Brooklyn, New York, 11230
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Canoga Park, California, 91304
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Cape Coral, Florida, 33991
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Charlotte, North Carolina, 28207
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Charlotte, North Carolina, 28210
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Charlotte, North Carolina, 28277
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Chevy Chase, Maryland, 20815
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Chicago, Illinois, 60644
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Cincinnati, Ohio, 45231
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Cincinnati, Ohio, 45242
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Clearwater, Florida, 33756
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Clearwater, Florida, 33765
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Clinton, South Carolina, 29325
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Colorado Springs, Colorado, 80907
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Colorado Springs, Colorado, 80909
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Columbia, South Carolina, 29203
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Columbus, Ohio, 43207
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Conroe, Texas, 77384
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Corsicana, Texas, 75110
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Dallas, Texas, 75225
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Dallas, Texas, 75231
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Dallas, Texas, 75246
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Dayton, Ohio, 45406
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Dayton, Ohio, 45459
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DeLand, Florida, 32720
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Denver, Colorado, 80206
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Denver, Colorado, 80230
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Denver, Colorado, 80246
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Dublin, Ohio, 43016
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East Providence, Rhode Island, 02914
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Edmond, Oklahoma, 73034
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El Paso, Texas, 79903
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Encinitas, California, 92024
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Erie, Pennsylvania, 16508
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Fall River, Massachusetts, 02723
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Fargo, North Dakota, 58104
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Farmington Hills, Michigan, 48336
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Flint, Michigan, 48504
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Flint, Michigan, 48507
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Gaffney, South Carolina, 29341
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Gainesville, Florida, 32653
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Galveston, Texas, 77555
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Gastonia, North Carolina, 28054
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Glendale, Arizona, 85306
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Greenacres City, Florida, 33467
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Greenfield, Wisconsin, 53228
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Greenville, South Carolina, 29607
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Hamtramck, Michigan, 48212
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Hawthorne, California, 90250
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Hazelwood, Missouri, 63042
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Hialeah, Florida, 33012
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High Point, North Carolina, 27262
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Houston, Texas, 77036
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Huntsville, Alabama, 35801
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Iowa City, Iowa, 52242
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Kerrville, Texas, 78028
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Kissimmee, Florida, 34741
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Las Vegas, Nevada, 89106
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Lincoln, Nebraska, 68505
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Little Rock, Arkansas, 72209
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Live Oak, Texas, 78233
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Long Beach, California, 90806
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Los Angeles, California, 90017
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Los Angeles, California, 90025
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Los Angeles, California, 90048
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Marlton, New Jersey, 08053
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Mayfield Heights, Ohio, 44124
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McKinney, Texas, 75069
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Medford, Oregon, 97504
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Meridian, Idaho, 83646
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Miami, Florida, 33125
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Miami, Florida, 33126
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Miami, Florida, 33135
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Miami, Florida, 33144
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Miami, Florida, 33173
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Miami, Florida, 33174
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Miami, Florida, 33175
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Miami, Florida, 33186
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Mobile, Alabama, 36608
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Monroe, North Carolina, 28112
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Montgomery, Alabama, 36106
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Morgantown, West Virginia, 26505
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Mt. Pleasant, South Carolina, 29464
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Murray, Utah, 84107
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Myrtle Beach, South Carolina, 29588
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New Brunswick, New Jersey, 08901
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New Hyde Park, New York, 11040
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Newport Beach, California, 92663
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Normal, Illinois, 61761
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North Charleston, South Carolina, 29420
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North Dartmouth, Massachusetts, 02747
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Oklahoma City, Oklahoma, 73112
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Orlando, Florida, 32806
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Orlando, Florida, 32819
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Overland Park, Kansas, 66210
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Oviedo, Florida, 32765
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Owensboro, Kentucky, 42301
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Palmetto Bay, Florida, 33157
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Panama City, Florida, 32405
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Pearland, Texas, 77584
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Pelzer, South Carolina, 29669
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Pembroke Pines, Florida, 33024
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Pembroke Pines, Florida, 33026
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Peoria, Arizona, 85381
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Philadelphia, Pennsylvania, 19140
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Pittsburgh, Pennsylvania, 15241
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Potsdam, New York, 13676
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Providence, Rhode Island, 02908
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Raleigh, North Carolina, 27607
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Rancho Cucamonga, California, 91730
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Redwood City, California, 94063
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Rochester, Michigan, 48307
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Rochester Hills, Michigan, 48307
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Rock Hill, South Carolina, 29732
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Sacramento, California, 95823
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Salt Lake City, Utah, 84107
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San Antonio, Texas, 78229
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San Antonio, Texas, 78230
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San Diego, California, 92120
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San Francisco, California, 94102
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San Jose, California, 95117
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Scottsboro, Alabama, 35768
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Scottsdale, Arizona, 85251
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Sheffield, Alabama, 35660
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Sherman, Texas, 75092
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South Burlington, Vermont, 05403
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Spartanburg, South Carolina, 29303
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St Louis, Missouri, 63110
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St Louis, Missouri, 63141
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St. Petersburg, Florida, 33707
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St. Petersburg, Florida, 33710
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The Bronx, New York, 10461
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The Woodlands, Texas, 77380
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Tomball, Texas, 77375
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Toms River, New Jersey, 08755
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Topeka, Kansas, 66606
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Tulsa, Oklahoma, 74136
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Tuscumbia, Alabama, 35674
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Waco, Texas, 76712
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Warwick, Rhode Island, 02886
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Waterbury, Connecticut, 06708
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Waxahachie, Texas, 75165
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Westminster, California, 92683
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White Marsh, Maryland, 21162
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Winder, Georgia, 30680
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Winston-Salem, North Carolina, 27104
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Ypsilanti, Michigan, 48197

Other trials in United States

Germany51 sites

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Augsburg
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Bad Wörishofen
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Bamberg
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Bergisch Gladbach
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Berlin, 10119
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Berlin, 10367
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Berlin, 10627
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Berlin, 10717
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Berlin, 10787
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Berlin, 12157
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Berlin, 12159
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Berlin, 12203
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Berlin, 13187
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Bonn
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Cologne
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Cottbus
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Darmstadt
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Delitzsch
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Dortmund
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Essen
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Frankfurt, 60389
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Frankfurt, 60596
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Geesthacht
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Gelsenkirchen
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Halle
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Hamburg, 20354
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Hamburg, 22299
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Hanover, 30167
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Hanover, 30173
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Homburg
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Jena
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Leipzig, 04107
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Leipzig, 04157
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Leipzig, 04207
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Leipzig, 04275
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Leipzig, 04357
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Lübeck, 23552
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Lübeck, 23558
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Magdeburg
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Marburg
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München, 80809
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München, 81241
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Neu-Isenburg
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Peine
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Potsdam
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Radebeul
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Reinfeld
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Rosenheim
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Schleswig
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Wiesbaden
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Witten

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Argentina23 sites

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Buenos Aires, C1121ABE
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Buenos Aires, C1128AAF
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Buenos Aires, C1414AJF
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Buenos Aires, C1424CSF
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Buenos Aires, C1425BEN
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Buenos Aires, C1425FVH
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Córdoba, X5003DCE
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Lanus, B1824KAJ
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Mar del Plata, B7602DCK
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Mendoza, 5500
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Mendoza, M5500GPD
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Quilmes, 1878
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Rosario, S2000DBS
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Rosario, S2000DEJ
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Rosario, S2000JKG
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Salta, A4400
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San Fernando, B1646EBJ
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San Juan Bautista, CP188
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San Miguel de Tucumán, T4000CBC
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San Miguel de Tucumán, T4000IAQ
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San Miguel de Tucumán, T4000
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Santa Fe, 2000
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Santa Fe, S3000ASF

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South Africa23 sites

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Athlone
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Bellville
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Benoni
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Bloemfontein
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Boksburg
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Cape Town, 7500
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Cape Town, 7505
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Durban, 4001
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Durban, 4091
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eMkhomazi
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Gatesville
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Johannesburg
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Kempton Park
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Kraaifontein
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Middelburg
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Mowbray, 7700
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Newtown
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Parktown
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Pretoria, 0002
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Pretoria, 0183
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Roodepoort
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Umhlanga
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United Kingdom17 sites

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Belfast
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Blackpool
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Bradford
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Chippenham
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Corby, NN17 2UR
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Corby, NN18 9EZ
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Kenilworth
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Liverpool
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London
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Newcastle upon Tyne
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Northwood
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Nottingham
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Peterborough
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Romford
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Shipley
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Sidcup
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Wokingham

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Ukraine16 sites

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Cherkasy
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Dnipro
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Ivano-Frankivsk
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Kharkiv, 61002
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Kharkiv, 61039
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Kharkiv, 61124
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Kherson
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Kyiv, 02232
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Kyiv, 03680
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Kyiv, 04201
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Lutsk
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Uzhhorod
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Vinnytsia
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Zaporizhzhya, 69035
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Zaporizhzhya, 69118
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Zaporizhzhya, 69600

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Czechia14 sites

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Beroun
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Brandýs nad Labem
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Jindřichův Hradec
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Kralupy nad Vltavou
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Kuřim
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Lovosice
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Miroslav
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Neratovice
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Prague, 110 00
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Prague, 14 800
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Rokycany
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Tábor
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Teplice
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Varnsdorf

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Canada10 sites

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Ajax, Ontario, L1S 2J5
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Burlington, Ontario, L7N 3V2
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Greater Sudbury, Ontario, P3A 1W8
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London, Ontario, N5W 6A2
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Newmarket, Ontario, L3Y5G8
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Québec, Quebec, C1G 3Y8
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Toronto, Ontario, M9V 4B4
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Vancouver, British Columbia, V5Z 4E1
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Waterloo, Ontario, N2J 1C4
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Windsor, Ontario, N8X 1T3

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Slovakia8 sites

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Bratislava
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Ilava
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Kežmarok
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Košice, 040 01
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Košice, 040 22
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Poprad
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Prešov
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Spain8 sites

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Barcelona, 08006
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Barcelona, 08035
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Barcelona, 08036
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Barcelona, 08916
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Girona
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Madrid
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Mérida
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Valencia

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Serbia5 sites

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Belgrade, 11000
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Kamenitz, 21204
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Kragujevac
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Niš
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About this study

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

Conditions: Asthma
Being tested: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg, Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg, Albuterol sulfate metered-dose inhaler 180 μg
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Budesonide/albuterol sulfate metered-dose inhaler 160/180 μgCombination product
Budesonide/albuterol sulfate combination inhalation aerosol
Budesonide/albuterol sulfate metered-dose inhaler 80/180 μgCombination product
Budesonide/albuterol sulfate combination inhalation aerosol
Albuterol sulfate metered-dose inhaler 180 μgDrug
Albuterol sulfate inhalation aerosol

Study groups in NCT03769090
Study group	Role	What they receive
BDA MDI (PT027) 160/180 μg	Experimental	Budesonide/albuterol sulfate, BDA MDI, PT027 high dose Receives: Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg
BDA MDI (PT027) 80/180 μg	Experimental	Budesonide/albuterol sulfate, BDA MDI, PT027 low dose Receives: Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg
AS MDI (PT007) 180 µg	Active comparator	Albuterol sulfate MDI, PT007 Receives: Drug: Albuterol sulfate metered-dose inhaler 180 μg

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With a Severe Asthma Exacerbation Event
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 one 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. The descriptive summary shows the number of participants with a severe exacerbation event, occurring between the date of randomization up to the date of randomized treatment discontinuation or a change in maintenance therapy.
Measured: From randomization up to a discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.

Secondary outcomes (4)

Annualized Severe Exacerbation Rate
The annualized severe exacerbation rate (severe exacerbations per year) is estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable.
Measured: From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.
Total Annualized Dose of Systemic Corticosteroid (SCS)
This endpoint includes all systemic corticosteroids (SCS) taken in response to a severe exacerbation event from randomization up to randomized treatment discontinuation or a change in maintenance therapy. All SCS are standardized to equipotent doses of prednisone before deriving the total dose. The total annualized dose is calculated as the total dose of SCS divided by the duration of the randomized treatment period.
Measured: From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.
Asthma Control Questionnaire-5 (ACQ-5) - Number of Participants Who Were Responders 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, so a lower score is the better outcome) is the mean of the 5 symptom items. A responder is defined as a participant with a decrease from baseline to Week 24 overall ACQ-5 score of 0.5 or more. ACQ-5 is not validated for children less than 6 years old, data for participants who were 4 or 5 years old was excluded from the analysis of ACQ-5.
Measured: From baseline to Week 24
Asthma Quality of Life Questionnaire for Participants Aged 12 Years and Older (AQLQ+12) - Number of Participants Who Were Responders at Week 24
The AQLQ+12 consists of 32 questions in 4 domains and is 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. A responder is defined as a participant with an increase from baseline to week 24 AQLQ-12 score of at least 0.5.
Measured: From baseline to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 20187 Feb 2022

First posted7 Dec 2018
Study start13 Dec 2018
Primary completion19 Aug 2021
Study completion7 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 3,132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03769090
Sponsor's protocol ID: AV003
Acronym: MANDALA
Status last verified: Sep 2022
First submitted: 30 Nov 2018
Last updated: 28 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Chipps BE, Albers FC, Reilly L, Johnsson E, Cappelletti C, Papi A. Efficacy and safety of as-needed albuterol/budesonide versus albuterol in adults and children aged >/=4 years with moderate-to-severe asthma: rationale and design of the randomised, double-blind, active-controlled MANDALA study. BMJ Open Respir Res. 2021 Dec;8(1):e001077. doi: 10.1136/bmjresp-2021-001077.
PubMed 34887317
Papi A, Chipps BE, Beasley R, Panettieri RA Jr, Israel E, Cooper M, Dunsire L, Jeynes-Ellis A, Johnsson E, Rees R, Cappelletti C, Albers FC. Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. N Engl J Med. 2022 Jun 2;386(22):2071-2083. doi: 10.1056/NEJMoa2203163. Epub 2022 May 15.
PubMed 35569035
Chipps BE, Panettieri RA Jr, Skolnik N, Cappelletti C, Daoud SZ, Dunsire L, Gilbert IA, Papi A. Albuterol-budesonide rescue inhaler for asthma: Patterns of use and safety in the MANDALA trial. Ann Allergy Asthma Immunol. 2026 Jan;136(1):54-60.e3. doi: 10.1016/j.anai.2025.07.008. Epub 2025 Jul 13.
PubMed 40664332
Kew KM, Flemyng E, Quon BS, Leung C. Increased versus stable doses of inhaled corticosteroids for exacerbations of chronic asthma in adults and children. Cochrane Database Syst Rev. 2022 Sep 26;9(9):CD007524. doi: 10.1002/14651858.CD007524.pub5.
PubMed 36161875

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03769090
Acronym / sponsor ID: MANDALA / AV003
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,132 participants (actual)
Lead sponsor: Bond Avillion 2 Development LPIndustry (pharma, biotech, devices)
Study start: 13 Dec 2018 (actual)
Primary completion: 19 Aug 2021 (actual)
Study completion: 7 Feb 2022 (actual)
First posted: 7 Dec 2018 (actual)
Results: Posted 28 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
BDA MDI (PT027) 160/180 μg	Experimental	Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μgBudesonide/albuterol sulfate, BDA MDI, PT027 high dose
BDA MDI (PT027) 80/180 μg	Experimental	Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/180 μgBudesonide/albuterol sulfate, BDA MDI, PT027 low dose
AS MDI (PT007) 180 µg	Active comparator	Drug: Albuterol sulfate metered-dose inhaler 180 μgAlbuterol sulfate MDI, PT007

Who may qualify

Ages: 4 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

Female or male aged ≥4 years at the time of informed consent
Physician diagnosis of asthma documented for at least 1 year
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:
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)
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

Key exclusion criteria (11 listed)

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)
Oral corticosteroid/SCS use (any dose and any indication) within 6 weeks before Visit 1
Chronic use of oral corticosteroids (OCS, ≥3 weeks use in 3 months prior to Visit 1)
Having received any marketed (e.g., omalizumab, mepolizumab, reslizumab, benralizumab) or investigational biologic within 3 months or any other prohibited medication
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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μgBudesonide/albuterol sulfate combination inhalation aerosol	Combination product	BDA MDI (PT027) 160/180 μg
Budesonide/albuterol sulfate metered-dose inhaler 80/180 μgBudesonide/albuterol sulfate combination inhalation aerosol	Combination product	BDA MDI (PT027) 80/180 μg
Albuterol sulfate metered-dose inhaler 180 μgAlbuterol sulfate inhalation aerosol	Drug	AS MDI (PT007) 180 µg

Primary outcome

Number of Participants With a Severe Asthma Exacerbation Event
Time frame: From randomization up to a discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.
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 one 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. The descriptive summary shows the number of participants with a severe exacerbation event, occurring between the date of randomization up to the date of randomized treatment discontinuation or a change in maintenance therapy.

4 secondary outcomes

Annualized Severe Exacerbation Rate
Time frame: From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.
Total Annualized Dose of Systemic Corticosteroid (SCS)
Time frame: From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.
Asthma Control Questionnaire-5 (ACQ-5) - Number of Participants Who Were Responders at Week 24
Time frame: From baseline to Week 24
Asthma Quality of Life Questionnaire for Participants Aged 12 Years and Older (AQLQ+12) - Number of Participants Who Were Responders at Week 24
Time frame: From baseline to 24 weeks

Results and safety

Results posted to the registry on 28 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BDA MDI (PT027) 160/180 μg	1,016	915
BDA MDI (PT027) 80/180 μg	1,057	933
AS MDI (PT007) 180 µg	1,059	916

Primary outcome: Number of Participants With a Severe Asthma Exacerbation Event

Time frame: From randomization up to a discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.. Count of participants. Unit: Participants

Measure	BDA MDI 160/180 μg (Full Analysis Set; >=12 Years) n = 1013	AS MDI 180 μg (Full Analysis Set; >=12 Years) n = 1014	BDA MDI 80/180 μg (Full Analysis Set) n = 1054	AS MDI 180 μg (Full Analysis Set) n = 1056
Value	207	266	241	276

BDA MDI 160/180 μg (Full Analysis Set; >=12 Years) vs AS MDI 180 μg (Full Analysis Set; >=12 Years): Hazard Ratio (HR): 0.733 (95% CI 0.611 to 0.879), p <0.001, Regression, Cox
BDA MDI 80/180 μg (Full Analysis Set) vs AS MDI 180 μg (Full Analysis Set): Hazard Ratio (HR): 0.835 (95% CI 0.702 to 0.992), p = 0.041, Regression, Cox

Population analysed: All participants that were randomized, took at least one puff of randomized treatment, and had at least one efficacy assessment, excluding participants confirmed as duplicates (n = 4). As children \<12 years of age were not randomized to the BDA MDI 160/180μg dose, comparison was made to the participants \>=12 years of age within the AS MDI 180μg arm.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported AEs are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation, which per protocol, was expected to be at least 24 weeks. The mean and median duration of exposure to randomized treatment for the reporting period for all participants was 44 and 48 weeks, respectively.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BDA MDI (PT027) 160/180 μg	53 of 1,015 (5.2%)	244 of 1,015 (24%)	4 of 1,015
BDA MDI (PT027) 80/180 μg	40 of 1,055 (3.8%)	253 of 1,055 (24%)	2 of 1,055
AS MDI (PT007) 180 µg	48 of 1,057 (4.5%)	243 of 1,057 (23%)	2 of 1,057

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 34887317Chipps BE, Albers FC, Reilly L, Johnsson E, Cappelletti C, Papi A. Efficacy and safety of as-needed albuterol/budesonide versus albuterol in adults and children aged >/=4 years with moderate-to-severe asthma: rationale and design of the randomised, double-blind, active-controlled MANDALA study. BMJ Open Respir Res. 2021 Dec;8(1):e001077. doi: 10.1136/bmjresp-2021-001077.
Results publication: PubMed 35569035Papi A, Chipps BE, Beasley R, Panettieri RA Jr, Israel E, Cooper M, Dunsire L, Jeynes-Ellis A, Johnsson E, Rees R, Cappelletti C, Albers FC. Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. N Engl J Med. 2022 Jun 2;386(22):2071-2083. doi: 10.1056/NEJMoa2203163. Epub 2022 May 15.
Derived from this study: PubMed 40664332Chipps BE, Panettieri RA Jr, Skolnik N, Cappelletti C, Daoud SZ, Dunsire L, Gilbert IA, Papi A. Albuterol-budesonide rescue inhaler for asthma: Patterns of use and safety in the MANDALA trial. Ann Allergy Asthma Immunol. 2026 Jan;136(1):54-60.e3. doi: 10.1016/j.anai.2025.07.008. Epub 2025 Jul 13.
Derived from this study: PubMed 36161875Kew KM, Flemyng E, Quon BS, Leung C. Increased versus stable doses of inhaled corticosteroids for exacerbations of chronic asthma in adults and children. Cochrane Database Syst Rev. 2022 Sep 26;9(9):CD007524. doi: 10.1002/14651858.CD007524.pub5.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Frank Albers, MD, PhD study director

Avillion LLP

345 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 345 sites in United States, Germany, Argentina, South Africa, United Kingdom and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Severe Asthma Exacerbation Event (time frame: From randomization up to a discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03769090, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.