Clinical trial NCT03769090: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Bond Avillion 2 Development LP
Sponsor class: INDUSTRY
First posted: 2018-12-07
Enrollment: 3132
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participants With a Severe Asthma Exacerbation Event
timeFrame: 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:
measure: Annualized Severe Exacerbation Rate
timeFrame: 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.
measure: Total Annualized Dose of Systemic Corticosteroid (SCS)
timeFrame: 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.
measure: Asthma Control Questionnaire-5 (ACQ-5) - Number of Participants Who Were Responders at Week 24
timeFrame: From baseline to Week 24
measure: Asthma Quality of Life Questionnaire for Participants Aged 12 Years and Older (AQLQ+12) - Number of Participants Who Were Responders at Week 24
timeFrame: From baseline to 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Montgomery
country: United States
facility: Research Site
state: Alabama
city: Scottsboro
country: United States
facility: Research Site
state: Alabama
city: Sheffield
country: United States
facility: Research Site
state: Alabama
city: Tuscumbia
country: United States
facility: Research Site
state: Alabama
city: Glendale
country: United States
facility: Research Site
state: Arizona
city: Peoria
country: United States
facility: Research Site
state: Arizona
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Bellflower
country: United States
facility: Research Site
state: California
city: Canoga Park
country: United States
facility: Research Site
state: California
city: Encinitas
country: United States
facility: Research Site
state: California
city: Hawthorne
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Newport Beach
country: United States
facility: Research Site
state: California
city: Rancho Cucamonga
country: United States
facility: Research Site
state: California
city: Redwood City
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: San Jose
country: United States
facility: Research Site
state: California
city: Westminster
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Waterbury
country: United States
facility: Research Site
state: Connecticut
city: Aventura
country: United States
facility: Research Site
state: Florida
city: Boynton Beach
country: United States
facility: Research Site
state: Florida
city: Cape Coral
country: United States
facility: Research Site
state: Florida
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: DeLand
country: United States
facility: Research Site
state: Florida
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Greenacres City
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Kissimmee
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Oviedo
country: United States
facility: Research Site
state: Florida
city: Palmetto Bay
country: United States
facility: Research Site
state: Florida
city: Panama City
country: United States
facility: Research Site
state: Florida
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Saint Petersburg
country: United States
facility: Research Site
state: Florida
city: Saint Petersburg
country: United States
facility: Research Site
state: Florida
city: Albany
country: United States
facility: Research Site
state: Georgia
city: Winder
country: United States
facility: Research Site
state: Georgia
city: Meridian
country: United States
facility: Research Site
state: Idaho
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Normal
country: United States
facility: Research Site
state: Illinois
city: Iowa City
country: United States
facility: Research Site
state: Iowa
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Topeka
country: United States
facility: Research Site
state: Kansas
city: Owensboro
country: United States
facility: Research Site
state: Kentucky
city: Bangor
country: United States
facility: Research Site
state: Maine
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Chevy Chase
country: United States
facility: Research Site
state: Maryland
city: White Marsh
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Fall River
country: United States
facility: Research Site
state: Massachusetts
city: North Dartmouth
country: United States
facility: Research Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Farmington Hills
country: United States
facility: Research Site
state: Michigan
city: Flint
country: United States
facility: Research Site
state: Michigan
city: Flint
country: United States
facility: Research Site
state: Michigan
city: Hamtramck
country: United States
facility: Research Site
state: Michigan
city: Rochester Hills
country: United States
facility: Research Site
state: Michigan
city: Rochester
country: United States
facility: Research Site
state: Michigan
city: Ypsilanti
country: United States
facility: Research Site
state: Michigan
city: Hazelwood
country: United States
facility: Research Site
state: Missouri
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Bellevue
country: United States
facility: Research Site
state: Nebraska
city: Bellevue
country: United States
facility: Research Site
state: Nebraska
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Brick
country: United States
facility: Research Site
state: New Jersey
city: Marlton
country: United States
facility: Research Site
state: New Jersey
city: New Brunswick
country: United States
facility: Research Site
state: New Jersey
city: Toms River
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Bronx
country: United States
facility: Research Site
state: New York
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: New Hyde Park
country: United States
facility: Research Site
state: New York
city: Potsdam
country: United States
facility: Research Site
state: New York
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Gastonia
country: United States
facility: Research Site
state: North Carolina
city: High Point
country: United States
facility: Research Site
state: North Carolina
city: Monroe
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Fargo
country: United States
facility: Research Site
state: North Dakota
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Dublin
country: United States
facility: Research Site
state: Ohio
city: Mayfield Heights
country: United States
facility: Research Site
state: Ohio
city: Edmond
country: United States
facility: Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Tulsa
country: United States
facility: Research Site
state: Oklahoma
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Blue Bell
country: United States
facility: Research Site
state: Pennsylvania
city: Erie
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: East Providence
country: United States
facility: Research Site
state: Rhode Island
city: Providence
country: United States
facility: Research Site
state: Rhode Island
city: Warwick
country: United States
facility: Research Site
state: Rhode Island
city: Anderson
country: United States
facility: Research Site
state: South Carolina
city: Clinton
country: United States
facility: Research Site
state: South Carolina
city: Columbia
country: United States
facility: Research Site
state: South Carolina
city: Gaffney
country: United States
facility: Research Site
state: South Carolina
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Research Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: Research Site
state: South Carolina
city: North Charleston
country: United States
facility: Research Site
state: South Carolina
city: Pelzer
country: United States
facility: Research Site
state: South Carolina
city: Rock Hill
country: United States
facility: Research Site
state: South Carolina
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Austin
country: United States
facility: Research Site
state: Texas
city: Austin
country: United States
facility: Research Site
state: Texas
city: Beaumont
country: United States
facility: Research Site
state: Texas
city: Boerne
country: United States
facility: Research Site
state: Texas
city: Conroe
country: United States
facility: Research Site
state: Texas
city: Corsicana
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: El Paso
country: United States
facility: Research Site
state: Texas
city: Galveston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Kerrville
country: United States
facility: Research Site
state: Texas
city: Live Oak
country: United States
facility: Research Site
state: Texas
city: McKinney
country: United States
facility: Research Site
state: Texas
city: Pearland
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Sherman
country: United States
facility: Research Site
state: Texas
city: The Woodlands
country: United States
facility: Research Site
state: Texas
city: Tomball
country: United States
facility: Research Site
state: Texas
city: Waco
country: United States
facility: Research Site
state: Texas
city: Waxahachie
country: United States
facility: Research Site
state: Texas
city: Murray
country: United States
facility: Research Site
state: Utah
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: South Burlington
country: United States
facility: Research Site
state: Vermont
city: Morgantown
country: United States
facility: Research Site
state: West Virginia
city: Greenfield
country: United States
facility: Research Site
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Research Site
city: Buenos Aires
country: Argentina
facility: Research Site
city: Buenos Aires
country: Argentina
facility: Research Site
city: Buenos Aires
country: Argentina
facility: Research Site
city: Buenos Aires
country: Argentina
facility: Research Site
city: Buenos Aires
country: Argentina
facility: Research Site
city: Córdoba
country: Argentina
facility: Research Site
city: Florencio Varela
country: Argentina
facility: Research Site
city: Lanús
country: Argentina
facility: Research Site
city: Mar Del Plata
country: Argentina
facility: Research Site
city: Mendoza
country: Argentina
facility: Research Site
city: Mendoza
country: Argentina
facility: Research Site
city: Quilmes
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: Salta
country: Argentina
facility: Research Site
city: San Fernando
country: Argentina
facility: Research Site
city: San Miguel De Tucumán
country: Argentina
facility: Research Site
city: San Miguel De Tucumán
country: Argentina
facility: Research Site
city: San Miguel De Tucumán
country: Argentina
facility: Research Site
city: Santa Fe
country: Argentina
facility: Research Site
city: Santa Fe
country: Argentina
facility: Research Site
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Ajax
country: Canada
facility: Research Site
state: Ontario
city: Burlington
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Waterloo
country: Canada
facility: Research Site
state: Ontario
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Québec
country: Canada
facility: Research Site
state: Quebec
city: Beroun
country: Czechia
facility: Research Site
city: Brandýs Nad Labem
country: Czechia
facility: Research Site
city: Jindřichův Hradec
country: Czechia
facility: Research Site
city: Kralupy Nad Vltavou
country: Czechia
facility: Research Site
city: Kuřim
country: Czechia
facility: Research Site
city: Lovosice
country: Czechia
facility: Research Site
city: Miroslav
country: Czechia
facility: Research Site
city: Neratovice
country: Czechia
facility: Research Site
city: Praha
country: Czechia
facility: Research Site
city: Praha
country: Czechia
facility: Research Site
city: Rokycany
country: Czechia
facility: Research Site
city: Teplice
country: Czechia
facility: Research Site
city: Tábor
country: Czechia
facility: Research Site
city: Varnsdorf
country: Czechia
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Bad Wörishofen
country: Germany
facility: Research Site
city: Bamberg
country: Germany
facility: Research Site
city: Bergisch Gladbach
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Cottbus
country: Germany
facility: Research Site
city: Darmstadt
country: Germany
facility: Research Site
city: Delitzsch
country: Germany
facility: Research Site
city: Dortmund
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Geesthacht
country: Germany
facility: Research Site
city: Gelsenkirchen
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Homburg
country: Germany
facility: Research Site
city: Jena
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Lübeck
country: Germany
facility: Research Site
city: Lübeck
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Neu Isenburg
country: Germany
facility: Research Site
city: Peine
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Radebeul
country: Germany
facility: Research Site
city: Reinfeld
country: Germany
facility: Research Site
city: Rosenheim
country: Germany
facility: Research Site
city: Schleswig
country: Germany
facility: Research Site
city: Wiesbaden
country: Germany
facility: Research Site
city: Witten
country: Germany
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Kragujevac
country: Serbia
facility: Research Site
city: Niš
country: Serbia
facility: Research Site
city: Sremska Kamenica
country: Serbia
facility: Research Site
city: Valjevo
country: Serbia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Ilava
country: Slovakia
facility: Research Site
city: Kezmarok
country: Slovakia
facility: Research Site
city: Košice
country: Slovakia
facility: Research Site
city: Košice
country: Slovakia
facility: Research Site
city: Poprad
country: Slovakia
facility: Research Site
city: Prešov
country: Slovakia
facility: Research Site
city: Žilina
country: Slovakia
facility: Research Site
city: Athlone
country: South Africa
facility: Research Site
city: Bellville
country: South Africa
facility: Research Site
city: Benoni
country: South Africa
facility: Research Site
city: Bloemfontein
country: South Africa
facility: Research Site
city: Boksburg
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Gatesville
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Kempton Park
country: South Africa
facility: Research Site
city: Kraaifontein
country: South Africa
facility: Research Site
city: Middelburg
country: South Africa
facility: Research Site
city: Mowbray
country: South Africa
facility: Research Site
city: Newtown
country: South Africa
facility: Research Site
city: Parktown
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Roodepoort
country: South Africa
facility: Research Site
city: Umhlanga
country: South Africa
facility: Research Site
city: Umkomaas
country: South Africa
facility: Research Site
city: Witbank
country: South Africa
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Girona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Mérida
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Cherkasy
country: Ukraine
facility: Research Site
city: Dnipro
country: Ukraine
facility: Research Site
city: Ivano-Frankivs'k
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kherson
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Luts'k
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Zaporizhzhya
country: Ukraine
facility: Research Site
city: Zaporizhzhya
country: Ukraine
facility: Research Site
city: Zaporizhzhya
country: Ukraine
facility: Research Site
city: Úzhgorod
country: Ukraine
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Blackpool
country: United Kingdom
facility: Research Site
city: Bradford
country: United Kingdom
facility: Research Site
city: Chippenham
country: United Kingdom
facility: Research Site
city: Corby
country: United Kingdom
facility: Research Site
city: Corby
country: United Kingdom
facility: Research Site
city: Kenilworth
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Research Site
city: Northwood
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Peterborough
country: United Kingdom
facility: Research Site
city: Romford
country: United Kingdom
facility: Research Site
city: Shipley
country: United Kingdom
facility: Research Site
city: Sidcup
country: United Kingdom
facility: Research Site
city: Wokingham
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Avillion LLP
name: Frank Albers, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.