Asthma Clinical Trial
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
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 12 years and above with asthma.
| Status | Not yet recruiting |
| Enrollment | 420 |
| Est. completion date | April 25, 2025 |
| Est. primary completion date | April 25, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility | Inclusion Criteria: 1. Participant of 12 years of age or older 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, for at least 12 weeks prior to the screening visit, with treatment that is anticipated to remain stable for the duration of the study: - 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. - Participants who utilize combination budesonide/formoterol (e.g., Symbicort) 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. Reversibility of disease evaluated by pulmonary function testing. 6. Participants should be able to withhold SABA for =6 hours and LABA-containing medications for =24 hours for the purposes of performing screening spirometry. 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. espiratory 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) 6. Long-acting muscarinic antagonist (LAMA) during the 3 months prior to the start of the study. 7. 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. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | GSK Investigational Site | Caba | Buenos Aires |
| Argentina | GSK Investigational Site | Ciudad de Buenos Aires | |
| Argentina | GSK Investigational Site | Mendoza | |
| Canada | GSK Investigational Site | Ajax | Ontario |
| Canada | GSK Investigational Site | Brampton | Ontario |
| Canada | GSK Investigational Site | Ottawa | Ontario |
| Canada | GSK Investigational Site | Quebec | |
| Canada | GSK Investigational Site | Quebec | |
| Canada | GSK Investigational Site | Toronto | Ontario |
| Canada | GSK Investigational Site | Windsor | Ontario |
| France | GSK Investigational Site | Amiens Cedex 1 | |
| France | GSK Investigational Site | Argenteuil | |
| France | GSK Investigational Site | Brest cedex | |
| France | GSK Investigational Site | Cannes Cedex | |
| France | GSK Investigational Site | Créteil Cedex | |
| France | GSK Investigational Site | Libourne Cedex | |
| France | GSK Investigational Site | Lille | |
| France | GSK Investigational Site | Poitiers cedex | |
| France | GSK Investigational Site | Pontoise | |
| France | GSK Investigational Site | Strasbourg Cedex | |
| Greece | GSK Investigational Site | Alexandroupolis | |
| Greece | GSK Investigational Site | Athina | |
| Greece | GSK Investigational Site | Heraklion, Crete | |
| Greece | GSK Investigational Site | Larissa | Thessaly |
| Greece | GSK Investigational Site | Thessaloniki | |
| Italy | GSK Investigational Site | Firenze | |
| Italy | GSK Investigational Site | Foggia | Puglia |
| Italy | GSK Investigational Site | Milano | Lombardia |
| Italy | GSK Investigational Site | Monserrato | Cagliari |
| Italy | GSK Investigational Site | Napoli | Campania |
| Italy | GSK Investigational Site | Padova | Veneto |
| Italy | GSK Investigational Site | Roma | Lazio |
| Italy | GSK Investigational Site | Torino | |
| Italy | GSK Investigational Site | Varese | Lombardia |
| Italy | GSK Investigational Site | Verona | Veneto |
| Panama | GSK Investigational Site | Ciudad de Panama | |
| Panama | GSK Investigational Site | Panama | |
| Panama | GSK Investigational Site | Panama | |
| Panama | GSK Investigational Site | Panama | |
| Poland | GSK Investigational Site | Bialystok | |
| Poland | GSK Investigational Site | Bielsko-Biala | |
| Poland | GSK Investigational Site | Elblag | |
| Poland | GSK Investigational Site | Katowice | |
| Poland | GSK Investigational Site | Katowice | |
| Poland | GSK Investigational Site | Ostrowiec Swietokrzyski | |
| Poland | GSK Investigational Site | Plock | |
| Poland | GSK Investigational Site | Tarnow | |
| United Kingdom | GSK Investigational Site | Ashton-under-Lyne | Greater Manchester |
| United Kingdom | GSK Investigational Site | Bebington | |
| United Kingdom | GSK Investigational Site | Corby | Northamptonshire |
| United Kingdom | GSK Investigational Site | Guisborough | South Tees |
| United Kingdom | GSK Investigational Site | Hounslow | |
| United Kingdom | GSK Investigational Site | Rhyl | Denbighshire |
| United Kingdom | GSK Investigational Site | Soham | Cambridgeshire |
| United Kingdom | GSK Investigational Site | Uttoxeter | |
| United States | GSK Investigational Site | Asheville | North Carolina |
| United States | GSK Investigational Site | Aventura | Florida |
| United States | GSK Investigational Site | Bellingham | Washington |
| United States | GSK Investigational Site | Brooklyn | New York |
| United States | GSK Investigational Site | Burleson | Texas |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Clearwater | Florida |
| United States | GSK Investigational Site | Columbia | Missouri |
| United States | GSK Investigational Site | Dublin | Ohio |
| United States | GSK Investigational Site | DuBois | Pennsylvania |
| United States | GSK Investigational Site | Edgewater | Florida |
| United States | GSK Investigational Site | Greenville | South Carolina |
| United States | GSK Investigational Site | Jersey City | New Jersey |
| United States | GSK Investigational Site | Louisville | Kentucky |
| United States | GSK Investigational Site | Medford | Oregon |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Minneapolis | Minnesota |
| United States | GSK Investigational Site | Olive Branch | Mississippi |
| United States | GSK Investigational Site | Owensboro | Kentucky |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Rincon | Georgia |
| United States | GSK Investigational Site | Riverdale | New Jersey |
| United States | GSK Investigational Site | Rock Hill | South Carolina |
| United States | GSK Investigational Site | Spartanburg | South Carolina |
| United States | GSK Investigational Site | Tomball | Texas |
| United States | GSK Investigational Site | Union | South Carolina |
| United States | GSK Investigational Site | Waco | Texas |
| United States | GSK Investigational Site | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States, Argentina, Canada, France, Greece, Italy, Panama, Poland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with Adverse Events (AEs) | Up to 3 months | ||
| Secondary | Number of participants with Serious Adverse Events (SAEs) | Up to 3 months | ||
| Secondary | Absolute Values of Minimum serum potassium (milliequivalents per litre (mEq/L) | Up to 3 months | ||
| Secondary | Absolute values of serum potassium (milligrams per decilitre) | Up to 3 months | ||
| Secondary | Change from baseline in serum potassium (milligrams per decilitre) | Up to 3 months | ||
| Secondary | Absolute value of haematology parameter: Platelet count (cells per microliter) | Up to 3 months | ||
| Secondary | Absolute value of haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter) | Up to 3 months | ||
| Secondary | Absolute value of haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters) | Up to 3 months | ||
| Secondary | Absolute value of haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms) | Up to 3 months | ||
| Secondary | Absolute values of haematology parameters: Reticulocytes (Percentage of reticulocytes) | Up to 3 months | ||
| Secondary | Absolute values of haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre) | Up to 3 months | ||
| Secondary | Absolute values of haematology parameters: haemoglobin (Hgb) (grams per decilitre) | Up to 3 months | ||
| Secondary | Absolute values of haematology parameters: haematocrit (Proportion of red blood cells in blood) | Up to 3 months | ||
| Secondary | 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) | Up to 3 months | ||
| Secondary | Absolute values of Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase,Alanine aminotransferase/serum glutamic-pyruvic transaminase, Alanine aminotransferase,Creatine phosphokinase (International Units per litre) | Up to 3 months | ||
| Secondary | Absolute value of routine urinalysis: potential of hydrogen (pH) | Up to 3 months | ||
| Secondary | Number of participants with abnormal urinalysis dipstick results: glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase | Up to 3 months | ||
| Secondary | Change from baseline in haematology parameter: Platelet count (cells per microliter) | Baseline (Day 1) and up to 3 months | ||
| Secondary | Change from baseline in haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter) | Baseline (Day 1) and up to 3 months | ||
| Secondary | Change from baseline in haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters) | Baseline (Day 1) and up to 3 months | ||
| Secondary | Change from baseline in haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms) | Baseline (Day 1) and up to 3 months | ||
| Secondary | Change from baseline in haematology parameters: Reticulocytes (Percentage of reticulocytes) | Baseline (Day 1) and up to 3 months | ||
| Secondary | Change from baseline in haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre) | Baseline (Day 1) and up to 3 months | ||
| Secondary | Change from baseline in haematology parameters: haemoglobin (Hgb) (grams per decilitre) | Baseline (Day 1) and up to 3 months | ||
| Secondary | Change from baseline in haematology parameters: haematocrit (Proportion of red blood cells in blood) | Baseline (Day 1) and up to 3 months | ||
| Secondary | 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) | Baseline (Day 1) and up to 3 months | ||
| Secondary | Change from baseline in Aspartate aminotransferase/ serum glutamic-oxaloacetic transaminase,Alanine aminotransferase/serum glutamic-pyruvic transaminase, Alanine aminotransferase,Creatine phosphokinase (International Units per litre) | Baseline (Day 1) and up to 3 months | ||
| Secondary | Change from baseline in routine urinalysis: pH | Baseline (Day 1) and up to 3 months | ||
| Secondary | Absolute values for vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [millimeters of mercury (mm Hg) | Up to 3 months | ||
| Secondary | Absolute values for vital signs: pulse rate [beats per min (bpm) | Up to 3 months | ||
| Secondary | Change from baseline in vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [millimeters of mercury (mm Hg) | Baseline (Day 1) and up to 3 months | ||
| Secondary | Change from baseline in vital signs: pulse rate [beats per min (bpm) | Baseline (Day 1) and up to 3 months | ||
| Secondary | Absolute values for 12 Lead ECGs in QTc (milliseconds) | Up to 3 months | ||
| Secondary | Absolute values for heart rate [beats per min (bpm) | Up to 3 months | ||
| Secondary | Change from baseline for 12 Lead ECGs in QTc (milliseconds) | Baseline (Day 1) and up to 3 months | ||
| Secondary | Change from baseline for heart rate [beats per min (bpm) | Baseline (Day 1) and up to 3 months |
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