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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06261957




Registration number
NCT06261957
Ethics application status
Date submitted
8/02/2024
Date registered
15/02/2024

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2023-509001-76-00
Secondary ID [2] 0 0
220735
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Salbutamol HFA-134a
Treatment: Drugs - Salbutamol HFA-152a

Experimental: Salbutamol Test Arm -

Active comparator: Salbutamol Reference Arm -


Treatment: Drugs: Salbutamol HFA-134a
100 microgram (µg) (ex-valve) at 30-second intervals per actuation

Treatment: Drugs: Salbutamol HFA-152a
100 µg (ex-valve) at 30-second intervals per actuation
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Adverse Events (AEs)
Timepoint [1] 0 0
Up to 3 months
Secondary outcome [1] 0 0
Number of participants with Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Up to 3 months
Secondary outcome [2] 0 0
Absolute Values of Minimum serum potassium (milliequivalents per litre [mEq/L])
Timepoint [2] 0 0
Up to 3 months
Secondary outcome [3] 0 0
Absolute values of serum potassium (milligrams per decilitre)
Timepoint [3] 0 0
Up to 3 months
Secondary outcome [4] 0 0
Change from baseline in serum potassium (milligrams per decilitre)
Timepoint [4] 0 0
Baseline (Day 1) and up to 3 months
Secondary outcome [5] 0 0
Absolute value of haematology parameter: Platelet count (cells per microliter)
Timepoint [5] 0 0
Up to 3 months
Secondary outcome [6] 0 0
Absolute value of haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)
Timepoint [6] 0 0
Up to 3 months
Secondary outcome [7] 0 0
Absolute value of haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)
Timepoint [7] 0 0
Up to 3 months
Secondary outcome [8] 0 0
Absolute value of haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)
Timepoint [8] 0 0
Up to 3 months
Secondary outcome [9] 0 0
Absolute values of haematology parameter: Reticulocytes (Percentage of reticulocytes)
Timepoint [9] 0 0
Up to 3 months
Secondary outcome [10] 0 0
Absolute values of haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
Timepoint [10] 0 0
Up to 3 months
Secondary outcome [11] 0 0
Absolute values of haematology parameter: haemoglobin (Hgb) (grams per decilitre)
Timepoint [11] 0 0
Up to 3 months
Secondary outcome [12] 0 0
Absolute values of haematology parameter: haematocrit (Proportion of red blood cells in blood)
Timepoint [12] 0 0
Up to 3 months
Secondary outcome [13] 0 0
Absolute values of Clinical Chemistry parameters: Glucose (non-fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre)
Timepoint [13] 0 0
Up to 3 months
Secondary outcome [14] 0 0
Absolute values of Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase, Alanine aminotransferase/serum glutamic-pyruvic transaminase, Alkaline phosphatase, Creatine phosphokinase (International Units per litre)
Timepoint [14] 0 0
Up to 3 months
Secondary outcome [15] 0 0
Absolute value of routine urinalysis: potential of hydrogen (pH)
Timepoint [15] 0 0
Up to 3 months
Secondary outcome [16] 0 0
Number of participants with abnormal urinalysis dipstick results: glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase
Timepoint [16] 0 0
Up to 3 months
Secondary outcome [17] 0 0
Change from baseline in haematology parameter: Platelet count (cells per microliter)
Timepoint [17] 0 0
Baseline (Day 1) and up to 3 months
Secondary outcome [18] 0 0
Change from baseline in haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)
Timepoint [18] 0 0
Baseline (Day 1) and up to 3 months
Secondary outcome [19] 0 0
Change from baseline in haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)
Timepoint [19] 0 0
Baseline (Day 1) and up to 3 months
Secondary outcome [20] 0 0
Change from baseline in haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)
Timepoint [20] 0 0
Baseline (Day 1) and up to 3 months
Secondary outcome [21] 0 0
Change from baseline in haematology parameter: Reticulocytes (Percentage of reticulocytes)
Timepoint [21] 0 0
Baseline (Day 1) and up to 3 months
Secondary outcome [22] 0 0
Change from baseline in haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
Timepoint [22] 0 0
Baseline (Day 1) and up to 3 months
Secondary outcome [23] 0 0
Change from baseline in haematology parameter: haemoglobin (Hgb) (grams per decilitre)
Timepoint [23] 0 0
Baseline (Day 1) and up to 3 months
Secondary outcome [24] 0 0
Change from baseline in haematology parameters: haematocrit (Proportion of red blood cells in blood)
Timepoint [24] 0 0
Baseline (Day 1) and up to 3 months
Secondary outcome [25] 0 0
Change from baseline in Clinical Chemistry parameters: Glucose (non-fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre)
Timepoint [25] 0 0
Baseline (Day 1) and up to 3 months
Secondary outcome [26] 0 0
Change from baseline in Aspartate aminotransferase/ serum glutamic-oxaloacetic transaminase,Alanine aminotransferase/serum glutamic-pyruvic transaminase, Alkaline phosphatase, Creatine phosphokinase (International Units per litre)
Timepoint [26] 0 0
Baseline (Day 1) and up to 3 months
Secondary outcome [27] 0 0
Change from baseline in routine urinalysis: pH
Timepoint [27] 0 0
Baseline (Day 1) and up to 3 months
Secondary outcome [28] 0 0
Absolute values for vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [millimeters of mercury (mm Hg)]
Timepoint [28] 0 0
Up to 3 months
Secondary outcome [29] 0 0
Absolute values for vital sign: pulse rate [beats per min (bpm)]
Timepoint [29] 0 0
Up to 3 months
Secondary outcome [30] 0 0
Change from baseline in vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [millimeters of mercury (mm Hg)]
Timepoint [30] 0 0
Baseline (Day 1) and up to 3 months
Secondary outcome [31] 0 0
Change from baseline in vital sign: pulse rate [beats per min (bpm)]
Timepoint [31] 0 0
Baseline (Day 1) and up to 3 months
Secondary outcome [32] 0 0
Absolute values for 12 Lead Electrocardiograms (ECGs) in Corrected QT interval (QTc) (milliseconds)
Timepoint [32] 0 0
Up to 3 months
Secondary outcome [33] 0 0
Absolute values for heart rate [beats per min (bpm)]
Timepoint [33] 0 0
Up to 3 months
Secondary outcome [34] 0 0
Change from baseline for 12 Lead ECGs in QTc (milliseconds)
Timepoint [34] 0 0
Baseline (Day 1) and up to 3 months
Secondary outcome [35] 0 0
Change from baseline for heart rate [beats per min (bpm)]
Timepoint [35] 0 0
Baseline (Day 1) and up to 3 months
Secondary outcome [36] 0 0
Change from baseline in Asthma Control Questionnaire (ACQ-6) score
Timepoint [36] 0 0
Baseline (Day 1) and up to 3 months
Secondary outcome [37] 0 0
Change from baseline for pre-bronchodilator Forced expiratory volume in 1 second (FEV1)
Timepoint [37] 0 0
Baseline (Day 1) and up to 3 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/09/2025
Actual
Sample size
Target
412
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Botany
Recruitment hospital [2] 0 0
GSK Investigational Site - Coffs Harbour
Recruitment hospital [3] 0 0
GSK Investigational Site - Kanwal
Recruitment hospital [4] 0 0
GSK Investigational Site - Murdoch
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2259 - Kanwal
Recruitment postcode(s) [4] 0 0
6163 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Mississippi
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Argentina
State/province [18] 0 0
Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
La Plata
Country [20] 0 0
Argentina
State/province [20] 0 0
Mendoza
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
France
State/province [23] 0 0
Amiens Cedex 1
Country [24] 0 0
France
State/province [24] 0 0
Argenteuil cedex
Country [25] 0 0
France
State/province [25] 0 0
Cannes
Country [26] 0 0
France
State/province [26] 0 0
CrEteil cedex
Country [27] 0 0
France
State/province [27] 0 0
Poitiers
Country [28] 0 0
France
State/province [28] 0 0
Pontoise
Country [29] 0 0
France
State/province [29] 0 0
Strasbourg
Country [30] 0 0
Greece
State/province [30] 0 0
Alexandroupolis
Country [31] 0 0
Greece
State/province [31] 0 0
Athens
Country [32] 0 0
Greece
State/province [32] 0 0
Larissa
Country [33] 0 0
Greece
State/province [33] 0 0
Thessaloniki
Country [34] 0 0
Italy
State/province [34] 0 0
Cagliari
Country [35] 0 0
Italy
State/province [35] 0 0
Firenze
Country [36] 0 0
Italy
State/province [36] 0 0
Foggia
Country [37] 0 0
Italy
State/province [37] 0 0
Milano
Country [38] 0 0
Italy
State/province [38] 0 0
Napoli
Country [39] 0 0
Italy
State/province [39] 0 0
Padova
Country [40] 0 0
Italy
State/province [40] 0 0
Roma
Country [41] 0 0
Italy
State/province [41] 0 0
Torino
Country [42] 0 0
Italy
State/province [42] 0 0
Tradate VA
Country [43] 0 0
Italy
State/province [43] 0 0
Verona
Country [44] 0 0
Panama
State/province [44] 0 0
Ciudad de Panama
Country [45] 0 0
Panama
State/province [45] 0 0
Panama
Country [46] 0 0
Philippines
State/province [46] 0 0
Iloilo City
Country [47] 0 0
Philippines
State/province [47] 0 0
Iloilo
Country [48] 0 0
Poland
State/province [48] 0 0
Bialystok
Country [49] 0 0
Poland
State/province [49] 0 0
Bielsko-Biala
Country [50] 0 0
Poland
State/province [50] 0 0
Chorzow
Country [51] 0 0
Poland
State/province [51] 0 0
Elblag
Country [52] 0 0
Poland
State/province [52] 0 0
Katowice
Country [53] 0 0
Poland
State/province [53] 0 0
Ostrowiec Swietokrzyski
Country [54] 0 0
Poland
State/province [54] 0 0
Plock
Country [55] 0 0
Poland
State/province [55] 0 0
Tarnow
Country [56] 0 0
Spain
State/province [56] 0 0
Barcelona
Country [57] 0 0
Spain
State/province [57] 0 0
BenalmAdena
Country [58] 0 0
Spain
State/province [58] 0 0
Madrid
Country [59] 0 0
Spain
State/province [59] 0 0
Marbella
Country [60] 0 0
Spain
State/province [60] 0 0
Pozuelo De AlarcOn Madr
Country [61] 0 0
Spain
State/province [61] 0 0
Santiago de Compostela
Country [62] 0 0
Thailand
State/province [62] 0 0
Pathumthani
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Bebington
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Cambridgeshire
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Corby
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Greater Manchester
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Guisborough
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Hounslow
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Rhyl
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Uttoxeter

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06261957