Phase 3 Asthma Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with asthma by a doctor for at least 12 months before the first study visit
• People who have been taking one of the specified asthma maintenance (regular, ongoing) treatments for at least 3 months, with the same dose for at least the last 4 weeks before the first visit
• People whose lung function test results fall within a specific range — between 40% and less than 90% of the expected normal value for adults, measured before using a reliever inhaler
• People whose airways have been shown to open up (improve) after using a reliever inhaler (albuterol/salbutamol)
• People who have had at least one serious asthma attack in the 12 months before the first visit
• People whose asthma symptom score (measured using a standard questionnaire called the ACQ-7) is 1.5 or higher at the first visit
• People whose asthma symptom score (measured using a related questionnaire called the ACQ-5) is 1.5 or higher at the second visit
• People who have been using a short-acting reliever inhaler (SABA) as needed for at least 3 months before the first visit
• People who used the study-provided reliever inhaler on at least 3 days during the last week before the second visit, due to asthma symptoms
• People who can demonstrate the correct technique for using a metered-dose inhaler (a specific type of puffer), as assessed by the study team — note that spacers are not allowed in this trial
• People who can correctly perform peak flow (breathing strength) measurements, as assessed by the study team
• People with a body mass index (a measure of body weight relative to height) below 40
• Women who could become pregnant must have a negative pregnancy test (urine test) at the first visit
• Women who could become pregnant must agree to use contraception to prevent pregnancy during the trial
• People who are willing to attend all required study visits and complete all assessments

Who may not be able to join:

• People who have chronic obstructive pulmonary disease (COPD) or another significant lung condition
• People who have used oral or injected corticosteroids (steroid tablets or injections) at any dose within 6 weeks before the first visit
• People who have regularly used oral corticosteroids for 3 or more weeks in the 3 months before the first visit
• People who have received a biologic medicine (a type of specialised treatment) — either an approved or experimental one — within 3 months or a certain timeframe before the first visit, or who have taken other medications that are not allowed in this trial
• People who currently smoke, people who smoked heavily in the past (more than 10 pack-years), or people who stopped smoking less than 6 months before the first visit
• People who have had a life-threatening asthma episode in the last 5 years that required being placed on a breathing machine, involved dangerously high carbon dioxide levels, involved a breathing emergency, caused seizures due to low oxygen, or caused loss of consciousness related to asthma
• People who have recently finished treatment for a lower respiratory tract infection or an asthma attack within 6 weeks before the first visit
• People who had an upper respiratory infection (such as a chest or throat infection) requiring antibiotics that had not cleared up within 7 days before the first visit
• People who have significantly abnormal results on laboratory (blood or urine) tests
• People who have a current or past history of another significant medical condition (confirm with trial site)
• People who have had cancer that has not been in full remission for at least 5 years before the first visit
• People with a history of psychiatric illness, intellectual disability, low motivation, or other conditions that may affect their ability to fully understand and consent to the study
• People who have a known or suspected allergy or sensitivity to albuterol, salbutamol, budesonide, or any ingredients in these medications
• People who are unable to avoid certain medications that are not permitted during the study
• People who have received a live vaccine within 7 days before the first visit
• People who are currently pregnant or breastfeeding
• People who experience more than one serious asthma attack during the screening period before the trial begins

Important: Always verify eligibility with the trial site directly before applying.