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)

September 1, 2022 updated by: Bond Avillion 2 Development LP

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3132

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1121ABE
        • Research Site
      • Buenos Aires, Argentina, C1128AAF
        • Research Site
      • Buenos Aires, Argentina, C1414AJF
        • Research Site
      • Buenos Aires, Argentina, C1424CSF
        • Research Site
      • Buenos Aires, Argentina, C1425BEN
        • Research Site
      • Buenos Aires, Argentina, C1425FVH
        • Research Site
      • Córdoba, Argentina, X5003DCE
        • Research Site
      • Florencio Varela, Argentina, CP188
        • Research Site
      • Lanús, Argentina, B1824KAJ
        • Research Site
      • Mar Del Plata, Argentina, B7602DCK
        • Research Site
      • Mendoza, Argentina, 5500
        • Research Site
      • Mendoza, Argentina, M5500GPD
        • Research Site
      • Quilmes, Argentina, 1878
        • Research Site
      • Rosario, Argentina, S2000DEJ
        • Research Site
      • Rosario, Argentina, S2000DBS
        • Research Site
      • Rosario, Argentina, S2000JKG
        • Research Site
      • Salta, Argentina, A4400
        • Research Site
      • San Fernando, Argentina, B1646EBJ
        • Research Site
      • San Miguel De Tucumán, Argentina, T4000CBC
        • Research Site
      • San Miguel De Tucumán, Argentina, T4000IAQ
        • Research Site
      • San Miguel De Tucumán, Argentina, T4000
        • Research Site
      • Santa Fe, Argentina, 2000
        • Research Site
      • Santa Fe, Argentina, S3000ASF
        • Research Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E1
        • Research Site
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Research Site
      • Burlington, Ontario, Canada, L7N 3V2
        • Research Site
      • London, Ontario, Canada, N5W 6A2
        • Research Site
      • Newmarket, Ontario, Canada, L3Y5G8
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      • Sudbury, Ontario, Canada, P3A 1W8
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      • Toronto, Ontario, Canada, M9V 4B4
        • Research Site
      • Waterloo, Ontario, Canada, N2J 1C4
        • Research Site
      • Windsor, Ontario, Canada, N8X 1T3
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    • Quebec
      • Québec, Quebec, Canada, C1G 3Y8
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  • Czechia
      • Beroun, Czechia
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      • Brandýs Nad Labem, Czechia
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      • Jindřichův Hradec, Czechia
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      • Kralupy Nad Vltavou, Czechia
        • Research Site
      • Kuřim, Czechia
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      • Lovosice, Czechia
        • Research Site
      • Miroslav, Czechia
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      • Neratovice, Czechia
        • Research Site
      • Praha, Czechia, 110 00
        • Research Site
      • Praha, Czechia, 14 800
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      • Rokycany, Czechia
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      • Teplice, Czechia
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      • Tábor, Czechia
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      • Varnsdorf, Czechia
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  • Germany
      • Augsburg, Germany
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      • Bad Wörishofen, Germany
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      • Bamberg, Germany
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      • Bergisch Gladbach, Germany
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      • Berlin, Germany, 10367
        • Research Site
      • Berlin, Germany, 10717
        • Research Site
      • Berlin, Germany, 10119
        • Research Site
      • Berlin, Germany, 10787
        • Research Site
      • Berlin, Germany, 12157
        • Research Site
      • Berlin, Germany, 12203
        • Research Site
      • Berlin, Germany, 13187
        • Research Site
      • Berlin, Germany, 12159
        • Research Site
      • Berlin, Germany, 10627
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      • Bonn, Germany
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      • Cottbus, Germany
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      • Darmstadt, Germany
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      • Delitzsch, Germany
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      • Dortmund, Germany
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      • Essen, Germany
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      • Frankfurt, Germany, 60596
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      • Frankfurt, Germany, 60389
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      • Geesthacht, Germany
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      • Gelsenkirchen, Germany
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      • Halle, Germany
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      • Hamburg, Germany, 20354
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      • Hamburg, Germany, 22299
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      • Hannover, Germany, 30167
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      • Hannover, Germany, 30173
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      • Homburg, Germany
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      • Jena, Germany
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      • Köln, Germany
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      • Leipzig, Germany, 04357
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      • Leipzig, Germany, 04207
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      • Leipzig, Germany, 04275
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      • Leipzig, Germany, 04107
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      • Leipzig, Germany, 04157
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      • Lübeck, Germany, 23552
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      • Lübeck, Germany, 23558
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      • Magdeburg, Germany
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      • Marburg, Germany
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      • München, Germany, 80809
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      • München, Germany, 81241
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      • Neu Isenburg, Germany
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      • Peine, Germany
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      • Potsdam, Germany
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      • Radebeul, Germany
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      • Reinfeld, Germany
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      • Rosenheim, Germany
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      • Schleswig, Germany
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      • Wiesbaden, Germany
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      • Witten, Germany
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  • Serbia
      • Belgrade, Serbia, 11000
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      • Kragujevac, Serbia
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      • Niš, Serbia
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      • Sremska Kamenica, Serbia, 21204
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      • Valjevo, Serbia
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  • Slovakia
      • Bratislava, Slovakia
        • Research Site
      • Ilava, Slovakia
        • Research Site
      • Kezmarok, Slovakia
        • Research Site
      • Košice, Slovakia, 040 01
        • Research Site
      • Košice, Slovakia, 040 22
        • Research Site
      • Poprad, Slovakia
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      • Prešov, Slovakia
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      • Žilina, Slovakia
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  • South Africa
      • Athlone, South Africa
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      • Bellville, South Africa
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      • Benoni, South Africa
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      • Bloemfontein, South Africa
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      • Boksburg, South Africa
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      • Cape Town, South Africa, 7505
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      • Cape Town, South Africa, 7500
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      • Durban, South Africa, 4001
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      • Durban, South Africa, 4091
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      • Gatesville, South Africa
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      • Johannesburg, South Africa
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      • Kempton Park, South Africa
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      • Kraaifontein, South Africa
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      • Middelburg, South Africa
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      • Mowbray, South Africa, 7700
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      • Newtown, South Africa
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      • Parktown, South Africa
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      • Pretoria, South Africa, 0002
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      • Pretoria, South Africa, 0183
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      • Roodepoort, South Africa
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      • Umhlanga, South Africa
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      • Umkomaas, South Africa
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      • Witbank, South Africa
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  • Spain
      • Barcelona, Spain, 08035
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      • Barcelona, Spain, 08036
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      • Barcelona, Spain, 08006
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      • Barcelona, Spain, 08916
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      • Girona, Spain
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      • Madrid, Spain
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      • Mérida, Spain
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      • Valencia, Spain
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  • Ukraine
      • Cherkasy, Ukraine
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      • Dnipro, Ukraine
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      • Ivano-Frankivs'k, Ukraine
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      • Kharkiv, Ukraine, 61002
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      • Kharkiv, Ukraine, 61039
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      • Kharkiv, Ukraine, 61124
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      • Kherson, Ukraine
        • Research Site
      • Kyiv, Ukraine, 02232
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      • Kyiv, Ukraine, 03680
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      • Kyiv, Ukraine, 04201
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      • Luts'k, Ukraine
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      • Vinnytsia, Ukraine
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      • Zaporizhzhya, Ukraine, 69118
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      • Zaporizhzhya, Ukraine, 69600
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      • Zaporizhzhya, Ukraine, 69035
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      • Úzhgorod, Ukraine
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  • United Kingdom
      • Belfast, United Kingdom
        • Research Site
      • Blackpool, United Kingdom
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      • Bradford, United Kingdom
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      • Chippenham, United Kingdom
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      • Corby, United Kingdom, NN17 2UR
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      • Corby, United Kingdom, NN18 9EZ
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      • Kenilworth, United Kingdom
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      • Liverpool, United Kingdom
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      • London, United Kingdom
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      • Newcastle Upon Tyne, United Kingdom
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      • Northwood, United Kingdom
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      • Nottingham, United Kingdom
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      • Peterborough, United Kingdom
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      • Romford, United Kingdom
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      • Shipley, United Kingdom
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      • Sidcup, United Kingdom
        • Research Site
      • Wokingham, United Kingdom
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  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Research Site
      • Huntsville, Alabama, United States, 35801
        • Research Site
      • Mobile, Alabama, United States, 36608
        • Research Site
      • Montgomery, Alabama, United States, 36106
        • Research Site
      • Scottsboro, Alabama, United States, 35768
        • Research Site
      • Sheffield, Alabama, United States, 35660
        • Research Site
      • Tuscumbia, Alabama, United States, 35674
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    • Arizona
      • Glendale, Arizona, United States, 85306
        • Research Site
      • Peoria, Arizona, United States, 85381
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      • Scottsdale, Arizona, United States, 85251
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    • Arkansas
      • Little Rock, Arkansas, United States, 72209
        • Research Site
    • California
      • Bakersfield, California, United States, 93301
        • Research Site
      • Bellflower, California, United States, 90706
        • Research Site
      • Canoga Park, California, United States, 91304
        • Research Site
      • Encinitas, California, United States, 92024
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      • Hawthorne, California, United States, 90250
        • Research Site
      • Long Beach, California, United States, 90806
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      • Los Angeles, California, United States, 90025
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      • Los Angeles, California, United States, 90017
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      • Los Angeles, California, United States, 90048
        • Research Site
      • Newport Beach, California, United States, 92663
        • Research Site
      • Rancho Cucamonga, California, United States, 91730
        • Research Site
      • Redwood City, California, United States, 94063
        • Research Site
      • Sacramento, California, United States, 95823
        • Research Site
      • San Diego, California, United States, 92120
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      • San Francisco, California, United States, 94102
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      • San Jose, California, United States, 95117
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      • Westminster, California, United States, 92683
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    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
      • Colorado Springs, Colorado, United States, 80907
        • Research Site
      • Colorado Springs, Colorado, United States, 80909
        • Research Site
      • Denver, Colorado, United States, 80206
        • Research Site
      • Denver, Colorado, United States, 80230
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      • Denver, Colorado, United States, 80246
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    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Research Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Research Site
      • Boynton Beach, Florida, United States, 33436
        • Research Site
      • Cape Coral, Florida, United States, 33991
        • Research Site
      • Clearwater, Florida, United States, 33765
        • Research Site
      • Clearwater, Florida, United States, 33756
        • Research Site
      • DeLand, Florida, United States, 32720
        • Research Site
      • Gainesville, Florida, United States, 32653
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      • Greenacres City, Florida, United States, 33467
        • Research Site
      • Hialeah, Florida, United States, 33012
        • Research Site
      • Kissimmee, Florida, United States, 34741
        • Research Site
      • Miami, Florida, United States, 33126
        • Research Site
      • Miami, Florida, United States, 33173
        • Research Site
      • Miami, Florida, United States, 33186
        • Research Site
      • Miami, Florida, United States, 33175
        • Research Site
      • Miami, Florida, United States, 33144
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      • Miami, Florida, United States, 33125
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      • Miami, Florida, United States, 33135
        • Research Site
      • Miami, Florida, United States, 33174
        • Research Site
      • Orlando, Florida, United States, 32806
        • Research Site
      • Orlando, Florida, United States, 32819
        • Research Site
      • Oviedo, Florida, United States, 32765
        • Research Site
      • Palmetto Bay, Florida, United States, 33157
        • Research Site
      • Panama City, Florida, United States, 32405
        • Research Site
      • Pembroke Pines, Florida, United States, 33024
        • Research Site
      • Pembroke Pines, Florida, United States, 33026
        • Research Site
      • Saint Petersburg, Florida, United States, 33710
        • Research Site
      • Saint Petersburg, Florida, United States, 33707
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    • Georgia
      • Albany, Georgia, United States, 31707
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      • Winder, Georgia, United States, 30680
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    • Idaho
      • Meridian, Idaho, United States, 83646
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60644
        • Research Site
      • Normal, Illinois, United States, 61761
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    • Iowa
      • Iowa City, Iowa, United States, 52242
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    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Research Site
      • Topeka, Kansas, United States, 66606
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    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Research Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Research Site
      • Chevy Chase, Maryland, United States, 20815
        • Research Site
      • White Marsh, Maryland, United States, 21162
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    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Research Site
      • Fall River, Massachusetts, United States, 02723
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      • North Dartmouth, Massachusetts, United States, 02747
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    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Research Site
      • Ann Arbor, Michigan, United States, 48106
        • Research Site
      • Farmington Hills, Michigan, United States, 48336
        • Research Site
      • Flint, Michigan, United States, 48504
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      • Flint, Michigan, United States, 48507
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      • Hamtramck, Michigan, United States, 48212
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      • Rochester, Michigan, United States, 48307
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      • Rochester Hills, Michigan, United States, 48307
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      • Ypsilanti, Michigan, United States, 48197
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    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Research Site
      • Saint Louis, Missouri, United States, 63110
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      • Saint Louis, Missouri, United States, 63141
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    • Nebraska
      • Bellevue, Nebraska, United States, 68005
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      • Bellevue, Nebraska, United States, 68123
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      • Lincoln, Nebraska, United States, 68505
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    • Nevada
      • Las Vegas, Nevada, United States, 89106
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    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Research Site
      • Marlton, New Jersey, United States, 08053
        • Research Site
      • New Brunswick, New Jersey, United States, 08901
        • Research Site
      • Toms River, New Jersey, United States, 08755
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    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Research Site
    • New York
      • Bronx, New York, United States, 10461
        • Research Site
      • Brooklyn, New York, United States, 11230
        • Research Site
      • New Hyde Park, New York, United States, 11040
        • Research Site
      • Potsdam, New York, United States, 13676
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    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Research Site
      • Charlotte, North Carolina, United States, 28277
        • Research Site
      • Charlotte, North Carolina, United States, 28207
        • Research Site
      • Charlotte, North Carolina, United States, 28210
        • Research Site
      • Gastonia, North Carolina, United States, 28054
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      • High Point, North Carolina, United States, 27262
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      • Monroe, North Carolina, United States, 28112
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      • Raleigh, North Carolina, United States, 27607
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      • Winston-Salem, North Carolina, United States, 27104
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    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Research Site
      • Cincinnati, Ohio, United States, 45242
        • Research Site
      • Columbus, Ohio, United States, 43207
        • Research Site
      • Dayton, Ohio, United States, 45459
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      • Dayton, Ohio, United States, 45406
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      • Dublin, Ohio, United States, 43016
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      • Mayfield Heights, Ohio, United States, 44124
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    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Research Site
      • Oklahoma City, Oklahoma, United States, 73112
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      • Tulsa, Oklahoma, United States, 74136
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    • Oregon
      • Medford, Oregon, United States, 97504
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    • Pennsylvania
      • Blue Bell, Pennsylvania, United States, 19422
        • Research Site
      • Erie, Pennsylvania, United States, 16508
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      • Philadelphia, Pennsylvania, United States, 19140
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      • Pittsburgh, Pennsylvania, United States, 15241
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    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
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      • Providence, Rhode Island, United States, 02908
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      • Warwick, Rhode Island, United States, 02886
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    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Research Site
      • Clinton, South Carolina, United States, 29325
        • Research Site
      • Columbia, South Carolina, United States, 29203
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      • Gaffney, South Carolina, United States, 29341
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      • Greenville, South Carolina, United States, 29607
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      • Mount Pleasant, South Carolina, United States, 29464
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      • Myrtle Beach, South Carolina, United States, 29588
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      • North Charleston, South Carolina, United States, 29420
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      • Pelzer, South Carolina, United States, 29669
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      • Rock Hill, South Carolina, United States, 29732
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      • Spartanburg, South Carolina, United States, 29303
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    • Texas
      • Austin, Texas, United States, 78759
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      • Austin, Texas, United States, 78726
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      • Beaumont, Texas, United States, 77702
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      • Boerne, Texas, United States, 78006
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      • Conroe, Texas, United States, 77384
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      • Corsicana, Texas, United States, 75110
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      • Dallas, Texas, United States, 75225
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      • Dallas, Texas, United States, 75246
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      • Dallas, Texas, United States, 75231
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      • El Paso, Texas, United States, 79903
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      • Galveston, Texas, United States, 77555
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      • Houston, Texas, United States, 77036
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      • Kerrville, Texas, United States, 78028
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      • Live Oak, Texas, United States, 78233
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      • McKinney, Texas, United States, 75069
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      • Pearland, Texas, United States, 77584
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      • San Antonio, Texas, United States, 78229
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      • San Antonio, Texas, United States, 78230
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      • Sherman, Texas, United States, 75092
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      • The Woodlands, Texas, United States, 77380
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      • Tomball, Texas, United States, 77375
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      • Waco, Texas, United States, 76712
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      • Waxahachie, Texas, United States, 75165
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    • Utah
      • Murray, Utah, United States, 84107
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      • Salt Lake City, Utah, United States, 84107
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    • Vermont
      • South Burlington, Vermont, United States, 05403
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    • West Virginia
      • Morgantown, West Virginia, United States, 26505
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    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BDA MDI (PT027) 160/180 μg
Budesonide/albuterol sulfate, BDA MDI, PT027 high dose
Combination product: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg
Budesonide/albuterol sulfate combination inhalation aerosol
Experimental: BDA MDI (PT027) 80/180 μg
Budesonide/albuterol sulfate, BDA MDI, PT027 low dose
Combination product: Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg
Budesonide/albuterol sulfate combination inhalation aerosol
Active Comparator: AS MDI (PT007) 180 µg
Albuterol sulfate MDI, PT007
Drug: Albuterol sulfate metered-dose inhaler 180 μg
Albuterol sulfate inhalation aerosol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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
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.
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
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.
From baseline to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bond Avillion 2 Development LP

Investigators

  • Study Director: Frank Albers, MD, PhD, Avillion LLP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2018

Primary Completion (Actual)

August 19, 2021

Study Completion (Actual)

February 7, 2022

Study Registration Dates

First Submitted

November 30, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (Actual)

December 7, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 1, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AV003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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