ACTIVE_NOT_RECRUITING

A Study to Assess and Compare Safety and Tolerability of 3 Months Treatment With Salbutamol Administered Via MDI Containing Propellant HFA-152a or HFA-134a in Participants ≥ 18 Years of Age With Asthma

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Conditions

AsthmaSalbutamolMDIHFA-152aHFA-134a

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to assess and compare the safety and tolerability of salbutamol administered via metered dose inhaler (MDI) containing propellant 1,1-difluoroethane (HFA-152a) or 1,1,1,2-tetrafluoroethane (HFA-134a) in participants aged \>=18 years with asthma

Official Title

A Randomized, Double-blind, Parallel Group, Multi-center Study to Evaluate the Long-term Safety of Salbutamol Rescue Medication When Administered Via Metered Dose Inhalers Containing the Propellant HFA-152a or Reference HFA-134a

Quick Facts

Study Start:2024-05-31
Study Completion:2025-09-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06261957

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participant of ≥18 years of age at the time of signing the informed consent or written informed consent is obtained from each study participant's legal guardian.
  2. 2. Asthma for ≥ 6 months, defined as:
  3. * Documented history of asthma, as defined by Global Initiative for Asthma (GINA) (GINA, 2023\]
  4. * Receiving one of the following asthma treatments, at a stable dose (applicable to daily Inhaled corticosteroid (ICS), ICS/Long-acting bronchodilator (LABA), and ICS/LABA/Long-acting muscarinic antagonist \[LAMA\]), for at least 12 weeks prior to the screening visit, with treatment that is anticipated to remain stable for the duration of the study:
  5. * Short-Acting Beta-2-Adrenoreceptor Agonists (SABA) used as needed for asthma symptoms
  6. * Daily maintenance low to medium dose Inhaled corticosteroid (ICS) (low to medium dose ICS defined as 100-500 μg/day fluticasone propionate or equivalent as defined in the 2023 GINA guidelines \[GINA, 2023\], plus Short-Acting Beta-2-Adrenoreceptor Agonists (SABA), which is anticipated to remain stable for the duration of the study.
  7. * Daily maintenance low to medium dose ICS/ Long-acting bronchodilator (LABA) (low to medium dose ICS defined as 100-500 μg/day fluticasone propionate or equivalent as defined in the GINA guidelines \[GINA, 2023\] plus SABA, which is anticipated to remain stable for the duration of the study.
  8. * Daily maintenance ICS/LABA/LAMA (low to medium dose ICS defined as 100-500 µg/day fluticasone propionate or equivalent as defined in the GINA guidelines \[GINA, 2023\] plus SABA, which is anticipated to remain stable for the duration of the study.
  9. * Participants who utilize combination budesonide/formoterol as reliever therapy, whether or not this is in addition to a SABA - are not eligible for screening.
  10. * Participants who utilize ICS/SABA combination therapy as reliever therapy, in addition to low to medium dose ICS or ICS/LABA as maintenance, are only eligible if they agree to discontinue their ICS/SABA inhaler for the duration of the study (screening through follow-up).
  11. 3. Severity of disease assessed by the investigator by baseline pre-bronchodilator Forced expiratory volume in 1 second (FEV1)
  12. 4. Asthma Control Status
  13. * Asthma Control Questionnaire (ACQ) 6 score \<1.5 at screening
  14. * Asthma that has remained stable with no severe exacerbations in the last 6 months. Severe exacerbation defined as:
  15. * Deterioration of asthma-requiring the use of systemic corticosteroids (tablets, suspension or injection), for at least 3 days, OR
  16. * An inpatient hospitalization or Emergency Department (ED) visit because of asthma, requiring systemic corticosteroids.
  17. 5. 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 up to 4 inhalations of albuterol/salbutamol aerosol.
  18. 6. Participants on as-needed SABA only, or daily maintenance ICS (plus as needed SABA):
  19. * With a documented history of reversibility (as defined above) within 2 years will meet this inclusion criterion. Pre- and post-bronchodilator measurements will still be collected at screening to characterize the degree of reversibility.
  20. * Who do not have a documented history of reversibility within the past 2 years will need to demonstrate reversibility during the screening period.
  21. * SABA should be withheld for ≥6 hours
  22. * Participants on daily maintenance ICS/LABA or ICS/LABA/LAMA:
  23. 7. Participants on daily maintenance ICS/LABA or ICS/LABA/LAMA:
  24. * Do not need to demonstrate reversibility in accordance with the above definition during the screening period. A reversibility maneuver will be performed to characterize the degree of post-bronchodilator change.
  25. * SABA should be withheld for ≥6 hours
  26. * LABA- and LAMA-containing medications should be withheld for \>=24 hours for the characterization of post-bronchodilator change.
  1. 1. A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.
  2. 2. 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 respiratory abnormalities other than asthma.
  3. 3. Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of screening that led to a change in asthma management, OR in the opinion of the Investigator, is expected to affect the participant's asthma status, OR the participant's ability to participate in the study.
  4. 4. Asthma Exacerbation: Any severe asthma exacerbation within 6 months prior to screening.
  5. 5. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) Biologic/immunosuppressive therapies used for the treatment of respiratory diseases during the 6 months, or 5 half-lives-whichever is longer-prior to start of the study.

Contacts and Locations

Principal Investigator

GSK Clinical Trials
STUDY_DIRECTOR
GlaxoSmithKline

Study Locations (Sites)

GSK Investigational Site
North Hollywood, California, 91606-3287
United States
GSK Investigational Site
San Mateo, California, 94403
United States
GSK Investigational Site
Colorado Springs, Colorado, 80909
United States
GSK Investigational Site
Aventura, Florida, 33180
United States
GSK Investigational Site
Clearwater, Florida, 33756
United States
GSK Investigational Site
DeLand, Florida, 32720
United States
GSK Investigational Site
Miami, Florida, 33144
United States
GSK Investigational Site
Miami, Florida, 33155
United States
GSK Investigational Site
Miami, Florida, 33173
United States
GSK Investigational Site
Naples, Florida, 34102
United States
GSK Investigational Site
Plantation, Florida, 33317
United States
GSK Investigational Site
Winter Park, Florida, 32789
United States
GSK Investigational Site
Rincon, Georgia, 31326
United States
GSK Investigational Site
Stonecrest, Georgia, 30038
United States
GSK Investigational Site
Louisville, Kentucky, 40217
United States
GSK Investigational Site
Owensboro, Kentucky, 42301
United States
GSK Investigational Site
Fall River, Massachusetts, 02723
United States
GSK Investigational Site
Minneapolis, Minnesota, 55402
United States
GSK Investigational Site
Minnesota, Minnesota, 56001
United States
GSK Investigational Site
Olive Branch, Mississippi, 38654
United States
GSK Investigational Site
Columbia, Missouri, 65203
United States
GSK Investigational Site
Henderson, Nevada, 89052
United States
GSK Investigational Site
Jersey City, New Jersey, 07306
United States
GSK Investigational Site
Riverdale, New Jersey, 07457
United States
GSK Investigational Site
Brooklyn, New York, 11220
United States
GSK Investigational Site
Asheville, North Carolina, 28803
United States
GSK Investigational Site
Winston-Salem, North Carolina, 27104
United States
GSK Investigational Site
Cincinnati, Ohio, 45231
United States
GSK Investigational Site
Dublin, Ohio, 43016
United States
GSK Investigational Site
Medford, Oregon, 97504
United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
United States
GSK Investigational Site
Pottstown, Pennsylvania, 19464
United States
GSK Investigational Site
Rock Hill, South Carolina, 29732
United States
GSK Investigational Site
Spartanburg, South Carolina, 29303
United States
GSK Investigational Site
Union, South Carolina, 29379
United States
GSK Investigational Site
Sugar Land, Texas, 77479
United States
GSK Investigational Site
Tomball, Texas, 77375
United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

  • GSK Clinical Trials, STUDY_DIRECTOR, GlaxoSmithKline

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 Registration Dates

Study Start Date2024-05-31
Study Completion Date2025-09-05

Study Record Updates

Study Start Date2024-05-31
Study Completion Date2025-09-05

Terms related to this study

Keywords Provided by Researchers

  • Asthma
  • Salbutamol
  • MDI
  • HFA-152a
  • HFA-134a

Additional Relevant MeSH Terms

  • Asthma