Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
GlaxoSmithKline (Voir sur ClinicalTrials)
mai 2024
septembre 2025
08 avril 2025
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | BOITIAUX Jean-François | 14/02/2025 09:03:16 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| GSK Investigational Site - 06614 - Cannes - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 67091 - Strasbourg - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 80054 - Amiens Cedex 1 - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 86021 - Poitiers - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 94010 - CrEteil cedex - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 95100 - Argenteuil cedex - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 95303 - Pontoise - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
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. 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 (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:
- Short-Acting Beta-2-Adrenoreceptor Agonists (SABA) used as needed for
asthma symptoms
- 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.
- 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.
- 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.
- Participants who utilize combination budesonide/formoterol as reliever
therapy, whether or not this is in addition to a SABA - are not eligible
for 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 only
eligible if they agree to discontinue their ICS/SABA inhaler for the
duration of the study (screening through follow-up).
3. Severity of disease assessed by the investigator by baseline pre-bronchodilator
Forced expiratory volume in 1 second (FEV1)
4. 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 6
months. 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 of
asthma, requiring systemic corticosteroids.
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.
6. 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 years
will meet this inclusion criterion. Pre- and post-bronchodilator measurements
will still be collected at screening to characterize the degree of
reversibility.
- Who do not have a documented history of reversibility within the past 2 years
will 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:
7. Participants on daily maintenance ICS/LABA or ICS/LABA/LAMA:
- 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.
- SABA should be withheld for ≥6 hours
- LABA- and LAMA-containing medications should be withheld for >=24 hours
for 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.
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. 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 (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:
- Short-Acting Beta-2-Adrenoreceptor Agonists (SABA) used as needed for
asthma symptoms
- 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.
- 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.
- 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.
- Participants who utilize combination budesonide/formoterol as reliever
therapy, whether or not this is in addition to a SABA - are not eligible
for 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 only
eligible if they agree to discontinue their ICS/SABA inhaler for the
duration of the study (screening through follow-up).
3. Severity of disease assessed by the investigator by baseline pre-bronchodilator
Forced expiratory volume in 1 second (FEV1)
4. 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 6
months. 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 of
asthma, requiring systemic corticosteroids.
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.
6. 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 years
will meet this inclusion criterion. Pre- and post-bronchodilator measurements
will still be collected at screening to characterize the degree of
reversibility.
- Who do not have a documented history of reversibility within the past 2 years
will 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:
7. Participants on daily maintenance ICS/LABA or ICS/LABA/LAMA:
- 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.
- SABA should be withheld for ≥6 hours
- LABA- and LAMA-containing medications should be withheld for >=24 hours
for 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.
1. A history of life-threatening asthma or asthma that is unstable in the opinion of
the investigator.
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. 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. Asthma Exacerbation: Any severe asthma exacerbation within 6 months prior to
screening.
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.