Clinical trial of new treatment for inadequately controlled Asthma

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Clinical trial of new treatment for inadequately controlled Asthma

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This page is dedicated to the recruitment of participants for a clinical trial of an investigational product for inadequately controlled Asthma to be conducted by the University of the Sunshine Coast (QLD).

Full title: A Phase III, randomized, double-blind, active controlled, parallel group study, comparing the efficacy, safety and tolerability of the fixed dose combination FF/UMEC/VI with the fixed dose dual combination of FF/VI, administered once-daily via a dry powder inhaler in subjects with inadequately controlled asthma.

You are invited to take part in this research project. This is because you have been diagnosed with Asthma.

The research project is testing the effectiveness and safety of a potential new triple therapy medicine to better manage and treat Asthma. Please complete the following survey to express interest in participating in the above-mentioned trial.

Please be aware that completion of the survey does not guarantee entry into the trial.

Ethics approval – Bellberry Limited

If you experience difficulty completing the survey please email trials@usc.edu.au

Are you aged over 18 years?
Have you been diagnosed with Asthma?
Were you diagnosed more than 12 months ago?
Have you visited your doctor due to acute Asthma symptoms in the last 12 months?
Have you been taking daily Asthma medication for at least the last 12 months?
Have you had pneumonia in the last 6 weeks?
Are you a current smoker?
Have you been diagnosed with COPD that began at age 40 or older?
Do you have any other respiratory diseases?
Would you be willing to replace your current Asthma relieving puffer (ie Ventolin) with a study-provided puffer at your first visit for use as needed through the study?
Would you be willing to discontinue your daily preventative Asthma medication to enter this trial?
Would you be willing to withhold your study-supplied puffer for 6 hours prior to each visit?
Would you be willing to maintain a daily electronic diary of your symptoms and do a twice daily breathing test for the duration of the trial (up to 52 weeks)?
Would you be willing to attend up to 9 clinic visits over the study period (up to 52 weeks)?
Would you be willing to stay at the clinic for up to 5 hours on 3 of those clinic visits?
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