Phase
Condition
Asthma
Treatment
Salbutamol HFA-134a
Salbutamol HFA-152a
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant of ≥18 years of age at the time of signing the informed consent orwritten informed consent is obtained from each study participant's legal guardian.
Asthma for ≥ 6 months, defined as:
Documented history of asthma, as defined by Global Initiative for Asthma (GINA) (GINA, 2023]
Receiving one of the following asthma treatments, at a stable dose (applicableto daily Inhaled corticosteroid (ICS), ICS/Long-acting bronchodilator (LABA),and ICS/LABA/Long-acting muscarinic antagonist [LAMA]), for at least 12 weeksprior to the screening visit, with treatment that is anticipated to remainstable for the duration of the study:
Short-Acting Beta-2-Adrenoreceptor Agonists (SABA) used as needed forasthma symptoms
Daily maintenance low to medium dose Inhaled corticosteroid (ICS) (low tomedium dose ICS defined as 100-500 μg/day fluticasone propionate orequivalent as defined in the 2023 GINA guidelines [GINA, 2023], plusShort-Acting Beta-2-Adrenoreceptor Agonists (SABA), which is anticipatedto remain stable for the duration of the study.
Daily maintenance low to medium dose ICS/ Long-acting bronchodilator (LABA) (low to medium dose ICS defined as 100-500 μg/day fluticasonepropionate or equivalent as defined in the GINA guidelines [GINA, 2023]plus SABA, which is anticipated to remain stable for the duration of thestudy.
Daily maintenance ICS/LABA/LAMA (low to medium dose ICS defined as 100-500 µg/day fluticasone propionate or equivalent as defined in the GINAguidelines [GINA, 2023] plus SABA, which is anticipated to remain stablefor the duration of the study.
Participants who utilize combination budesonide/formoterol as relievertherapy, whether or not this is in addition to a SABA - are not eligiblefor screening.
Participants who utilize ICS/SABA combination therapy as reliever therapy,in addition to low to medium dose ICS or ICS/LABA as maintenance, are onlyeligible if they agree to discontinue their ICS/SABA inhaler for theduration of the study (screening through follow-up).
Severity of disease assessed by the investigator by baseline pre-bronchodilatorForced expiratory volume in 1 second (FEV1)
Asthma Control Status
Asthma Control Questionnaire (ACQ) 6 score <1.5 at screening
Asthma that has remained stable with no severe exacerbations in the last 6months. Severe exacerbation defined as:
Deterioration of asthma-requiring the use of systemic corticosteroids (tablets, suspension or injection), for at least 3 days, OR
An inpatient hospitalization or Emergency Department (ED) visit because ofasthma, requiring systemic corticosteroids.
Evidence of reversibility of disease: Airway reversibility is defined as ≥12 percent (%) and ≥200 milliliter (mL) increase in FEV1 within 20 to 60 minutes following upto 4 inhalations of albuterol/salbutamol aerosol.
Participants on as-needed SABA only, or daily maintenance ICS (plus as needed SABA):
With a documented history of reversibility (as defined above) within 2 yearswill meet this inclusion criterion. Pre- and post-bronchodilator measurementswill still be collected at screening to characterize the degree ofreversibility.
Who do not have a documented history of reversibility within the past 2 yearswill need to demonstrate reversibility during the screening period.
SABA should be withheld for ≥6 hours
Participants on daily maintenance ICS/LABA or ICS/LABA/LAMA:
- Participants on daily maintenance ICS/LABA or ICS/LABA/LAMA:
- Do not need to demonstrate reversibility in accordance with the abovedefinition during the screening period. A reversibility maneuver will beperformed to characterize the degree of post-bronchodilator change.
- SABA should be withheld for ≥6 hours
- LABA- and LAMA-containing medications should be withheld for >=24 hoursfor the characterization of post-bronchodilator change.
Participants should be able to withhold SABA for ≥6 hours and LABA-/ LAMA containing medications for ≥24 hours for the purposes of performing screening spirometry.
Exclusion
Exclusion Criteria:
A history of life-threatening asthma or asthma that is unstable in the opinion ofthe investigator.
Other significant pulmonary diseases to include (but not limited to): pneumothorax,pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis,emphysema, chronic obstructive pulmonary disease, tuberculosis or other respiratoryabnormalities other than asthma.
Respiratory Infection: Culture-documented or suspected bacterial or viral infectionof the upper or lower respiratory tract, sinus or middle ear that is not resolvedwithin 4 weeks of screening that led to a change in asthma management, OR in theopinion of the Investigator, is expected to affect the participant's asthma status,OR the participant's ability to participate in the study.
Asthma Exacerbation: Any severe asthma exacerbation within 6 months prior toscreening.
Current or chronic history of liver disease or known hepatic or biliaryabnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)Biologic/immunosuppressive therapies used for the treatment of respiratory diseasesduring the 6 months, or 5 half-lives-whichever is longer-prior to start of thestudy.
Study Design
Connect with a study center
GSK Investigational Site
Caba, Buenos Aires C1425BEN
ArgentinaSite Not Available
GSK Investigational Site
Buenos Aires, C1425AZE
ArgentinaActive - Recruiting
GSK Investigational Site
Ciudad de Buenos Aires, C1425AZE
ArgentinaSite Not Available
GSK Investigational Site
La Plata, 1900
ArgentinaActive - Recruiting
GSK Investigational Site
Mendoza, M5500CCG
ArgentinaActive - Recruiting
GSK Investigational Site
Botany, New South Wales 2019
AustraliaActive - Recruiting
GSK Investigational Site
Coffs Harbour, New South Wales 2450
AustraliaActive - Recruiting
GSK Investigational Site
Kanwal, New South Wales 2259
AustraliaActive - Recruiting
GSK Investigational Site
Murdoch, Western Australia 6163
AustraliaActive - Recruiting
GSK Investigational Site
Spearwood, Western Australia 6163
AustraliaSite Not Available
GSK Investigational Site
Ajax, Ontario L1S 2J5
CanadaActive - Recruiting
GSK Investigational Site
Brampton, Ontario L6T 0G1
CanadaActive - Recruiting
GSK Investigational Site
Ottawa, Ontario K1H 1E4
CanadaActive - Recruiting
GSK Investigational Site
Toronto, Ontario M9V 4B4
CanadaActive - Recruiting
GSK Investigational Site
Windsor, Ontario N8X 2G1
CanadaActive - Recruiting
GSK Investigational Site
Quebec, G1W 4R4
CanadaActive - Recruiting
GSK Investigational Site
Amiens Cedex 1, 80054
FranceActive - Recruiting
GSK Investigational Site
Argenteuil, 95100
FranceSite Not Available
GSK Investigational Site
Argenteuil cedex, 95100
FranceActive - Recruiting
GSK Investigational Site
Brest cedex, 29609
FranceSite Not Available
GSK Investigational Site
Cannes, 06614
FranceActive - Recruiting
GSK Investigational Site
Cannes Cedex, 06614
FranceSite Not Available
GSK Investigational Site
CrEteil cedex, 94010
FranceActive - Recruiting
GSK Investigational Site
Créteil Cedex, 94010
FranceSite Not Available
GSK Investigational Site
Libourne Cedex, 33505
FranceSite Not Available
GSK Investigational Site
Lille, 59000
FranceSite Not Available
GSK Investigational Site
Poitiers, 86021
FranceActive - Recruiting
GSK Investigational Site
Poitiers cedex, 86021
FranceSite Not Available
GSK Investigational Site
Pontoise, 95303
FranceActive - Recruiting
GSK Investigational Site
Strasbourg, 67091
FranceActive - Recruiting
GSK Investigational Site
Strasbourg Cedex, 67091
FranceSite Not Available
GSK Investigational Site
Alexandroupolis, 68100
GreeceActive - Recruiting
GSK Investigational Site
Athens, 15669
GreeceActive - Recruiting
GSK Investigational Site
Athina, 11527
GreeceSite Not Available
GSK Investigational Site
Heraklion, Crete, 71500
GreeceSite Not Available
GSK Investigational Site
Larissa, 41110
GreeceActive - Recruiting
GSK Investigational Site
Thessaloniki, 57010
GreeceActive - Recruiting
GSK Investigational Site
Monserrato, Cagliari 09042
ItalySite Not Available
GSK Investigational Site
Varese, Lombardia 21100
ItalySite Not Available
GSK Investigational Site
Cagliari, 09042
ItalyActive - Recruiting
GSK Investigational Site
Firenze, 50134
ItalyActive - Recruiting
GSK Investigational Site
Foggia, 71100
ItalyActive - Recruiting
GSK Investigational Site
Milano, 20162
ItalyActive - Recruiting
GSK Investigational Site
Napoli, 80131
ItalyActive - Recruiting
GSK Investigational Site
Padova, 35128
ItalyActive - Recruiting
GSK Investigational Site
Roma,
ItalyActive - Recruiting
GSK Investigational Site
Torino, 10128
ItalyActive - Recruiting
GSK Investigational Site
Tradate VA, 21100
ItalyActive - Recruiting
GSK Investigational Site
Verona, 37134
ItalyActive - Recruiting
GSK Investigational Site
Ciudad de Panama, 7099
PanamaActive - Recruiting
GSK Investigational Site
Panama,
PanamaActive - Recruiting
GSK Investigational Site
Iloilo, 5000
PhilippinesActive - Recruiting
GSK Investigational Site
Iloilo City, 5000
PhilippinesActive - Recruiting
GSK Investigational Site
Jaro, Iloilo City, 5000
PhilippinesSite Not Available
GSK Investigational Site
Bialystok, 15-010
PolandActive - Recruiting
GSK Investigational Site
Bielsko-Biala, 43-300
PolandActive - Recruiting
GSK Investigational Site
Chorzow, 41-500
PolandActive - Recruiting
GSK Investigational Site
Elblag, 82-300
PolandActive - Recruiting
GSK Investigational Site
Katowice, 40-600
PolandActive - Recruiting
GSK Investigational Site
Ostrowiec Swietokrzyski, 27-400
PolandActive - Recruiting
GSK Investigational Site
Plock, 09-407
PolandActive - Recruiting
GSK Investigational Site
Tarnow, 33-100
PolandActive - Recruiting
GSK Investigational Site
Marbella - Málaga, Andalucia 29603
SpainSite Not Available
GSK Investigational Site
Pozuelo De Alarcón, Madrid 28223
SpainSite Not Available
GSK Investigational Site
Barcelona, 08540
SpainActive - Recruiting
GSK Investigational Site
BenalmAdena, 29631
SpainActive - Recruiting
GSK Investigational Site
Benalmádena, 29631
SpainSite Not Available
GSK Investigational Site
Centelles, 08540
SpainSite Not Available
GSK Investigational Site
Granada, 18014
SpainSite Not Available
GSK Investigational Site
Madrid, 28040
SpainActive - Recruiting
GSK Investigational Site
Marbella, 29603
SpainActive - Recruiting
GSK Investigational Site
Pozuelo De AlarcOn Madr, 28223
SpainActive - Recruiting
GSK Investigational Site
Santiago de Compostela, 15706
SpainActive - Recruiting
GSK Investigational Site
Pathumthani, 12120
ThailandActive - Recruiting
GSK Investigational Site
Soham, Cambridgeshire CB7 5JD
United KingdomSite Not Available
GSK Investigational Site
Ashton-under-Lyne, Greater Manchester OL6 6HD
United KingdomSite Not Available
GSK Investigational Site
Bebington, CH63 9JP
United KingdomActive - Recruiting
GSK Investigational Site
Cambridgeshire, CB7 5JD
United KingdomActive - Recruiting
GSK Investigational Site
Corby, NN17 2UR
United KingdomActive - Recruiting
GSK Investigational Site
Greater Manchester, OL6 6HD
United KingdomActive - Recruiting
GSK Investigational Site
Guisborough, TS14 7DJ
United KingdomActive - Recruiting
GSK Investigational Site
Hounslow, TW3 3EL
United KingdomActive - Recruiting
GSK Investigational Site
Rhyl, LL18 4HZ
United KingdomActive - Recruiting
GSK Investigational Site
Uttoxeter, ST14 5JX
United KingdomActive - Recruiting
GSK Investigational Site
North Hollywood, California 91606-3287
United StatesActive - Recruiting
GSK Investigational Site
San Mateo, California 94403
United StatesActive - Recruiting
GSK Investigational Site
Aventura, Florida 33180
United StatesActive - Recruiting
GSK Investigational Site
Clearwater, Florida 33756
United StatesActive - Recruiting
GSK Investigational Site
DeLand, Florida 32720
United StatesActive - Recruiting
GSK Investigational Site
Edgewater, Florida 32132
United StatesSite Not Available
GSK Investigational Site
Miami, Florida 33173
United StatesActive - Recruiting
GSK Investigational Site
Naples, Florida 34102
United StatesActive - Recruiting
GSK Investigational Site
Plantation, Florida 33317
United StatesActive - Recruiting
GSK Investigational Site
Winter Park, Florida 32789
United StatesActive - Recruiting
GSK Investigational Site
Rincon, Georgia 31326
United StatesActive - Recruiting
GSK Investigational Site
Stonecrest, Georgia 30038
United StatesActive - Recruiting
GSK Investigational Site
Louisville, Kentucky 40217
United StatesActive - Recruiting
GSK Investigational Site
Owensboro, Kentucky 42301
United StatesActive - Recruiting
GSK Investigational Site
Mankato, Minnesota 56001
United StatesSite Not Available
GSK Investigational Site
Minneapolis, Minnesota 55402
United StatesActive - Recruiting
GSK Investigational Site
Minnesota, Minnesota 56001
United StatesActive - Recruiting
GSK Investigational Site
Olive Branch, Mississippi 38654
United StatesActive - Recruiting
GSK Investigational Site
Columbia, Missouri 65203
United StatesActive - Recruiting
GSK Investigational Site
Henderson, Nevada 89052
United StatesActive - Recruiting
GSK Investigational Site
Jersey City, New Jersey 07306
United StatesActive - Recruiting
GSK Investigational Site
Riverdale, New Jersey 07457
United StatesActive - Recruiting
GSK Investigational Site
Brooklyn, New York 11220
United StatesActive - Recruiting
GSK Investigational Site
Asheville, North Carolina 28803
United StatesActive - Recruiting
GSK Investigational Site
Winston-Salem, North Carolina 27104
United StatesActive - Recruiting
GSK Investigational Site
Cincinnati, Ohio 45231
United StatesActive - Recruiting
GSK Investigational Site
Dublin, Ohio 43016
United StatesActive - Recruiting
GSK Investigational Site
Medford, Oregon 97504
United StatesActive - Recruiting
GSK Investigational Site
DuBois, Pennsylvania 15801
United StatesSite Not Available
GSK Investigational Site
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
GSK Investigational Site
Pittsburgh, Pennsylvania 15241
United StatesActive - Recruiting
GSK Investigational Site
Pottstown, Pennsylvania 19464
United StatesActive - Recruiting
GSK Investigational Site
Greenville, South Carolina 29615
United StatesActive - Recruiting
GSK Investigational Site
Rock Hill, South Carolina 29732
United StatesActive - Recruiting
GSK Investigational Site
Spartanburg, South Carolina 29303
United StatesActive - Recruiting
GSK Investigational Site
Union, South Carolina 29379
United StatesActive - Recruiting
GSK Investigational Site
Burleson, Texas 76028
United StatesSite Not Available
GSK Investigational Site
Tomball, Texas 77375
United StatesActive - Recruiting
GSK Investigational Site
Waco, Texas 76712
United StatesSite Not Available
GSK Investigational Site
Bellingham, Washington 98225
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.