Phase 3 Asthma Trial, Recruiting

Written by an AI model from 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 had a confirmed asthma diagnosis for at least 12 months.
• People who have been on a stable asthma maintenance treatment (using an inhaled corticosteroid, with or without other add-on asthma medicines) for at least 3 months, with the dose unchanged for at least the last month.
• People who use a short-acting reliever inhaler (such as a blue puffer) as needed.
• People who have had at least one serious asthma attack in the past 12 months that required additional treatment.
• People who are willing to use the reliever inhaler provided by the trial sponsor during the study.
• People who can show the correct technique for using a metered-dose inhaler (puffer), without using a spacer device.
• People who can correctly perform a breathing test called a peak flow measurement, as assessed by the trial team.
• People with a body mass index (a measure of body weight relative to height) below 40.
• People who are willing and able to follow the contraception methods required by the trial.
• People who return a negative pregnancy test at screening (where applicable).
• Participants who are minors must have a caregiver able to provide written consent on their behalf, and the participant must also be willing to provide their own assent (agreement) to take part.

Who may not be able to join:

• People who have had a life-threatening asthma episode involving breathing failure, seizures due to low oxygen, loss of consciousness related to asthma, or the need for a breathing tube.
• People who have had more than 3 serious asthma attacks in the 12 months before screening.
• People who finished a course of oral steroids or antibiotics for a chest infection or serious asthma attack within 4 weeks before screening.
• People who currently have an upper respiratory infection (such as a chest cold) that required antibiotics and has not fully resolved.
• Current smokers, people who smoked more than the equivalent of one pack per day for 10 years, or people who stopped smoking (including cigarettes, e-cigarettes/vaping, or marijuana) less than 6 months ago.
• People with another significant lung condition, or who need to use oxygen regularly or occasionally.
• People with a significant ongoing medical condition affecting the heart, liver, kidneys, blood, nervous system, hormones, or digestive system.
• People who have had cancer that has not been in complete remission for at least 5 years.
• People who have been hospitalised for a psychiatric (mental health) condition, or who have attempted suicide, within the past year.
• People with significant alcohol or drug misuse, based on the assessment of the trial doctor.
• People who have used oral steroid tablets (for any reason) within 4 weeks before the first visit, or who have used them regularly (3 or more weeks in the 3 months before the first visit).
• People who have used oral reliever medications (oral short-acting bronchodilators) within the past month.
• People with a known allergy or sensitivity to albuterol/salbutamol or budesonide, or to any of the ingredients in these medicines.

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