An investigation of FX125L in patients with asthma

• Research type

  Research Study

• Full title

  An Exploratory Phase IIa Study to Investigate the Biological Activity of Oral FX125L in Adult Patients with Mild to Moderate Asthma

• IRAS ID

  157972

• Contact name

• Sponsor organisation

  STX Pharma Ltd.

• Eudract number

  2014-002052-84

• Research summary

  We are conducting a clinical trial with a new experimental drug called FX125L in up to 52 patients with mild to moderate asthma. We want to find out how well FX125L can reduce the symptoms of asthma so we will assess the effect of FX125L on FEV (Forced Expiry Volume) by spirometry; which is a lung function test. We will also assess other biological markers in sputum and collect information on patients symptoms and side-effects using specific questionnaire based assessments and diary cards completed by the patients. The results from this study will enable us to plan further studies to determine whether FX125L is an effective treatment for asthma. The study will be conducted at a single centre (Clinical Trial Unit) at Richmond Pharmacology Ltd and will last approximately 17 weeks including the time when we determine who is suitable for taking part in the study, and the follow-up at the end of the study. Patients will attend our unit for 6 visits in total which will include a residential stay overnight and will be treated with FXT125L for 56 days, mainly by self-dosing at home.

  Patients with asthma often experience relapses with shortness of breath and long term damage caused by the chronic inflammation as well as side effects from the medicines they have to take so there is an unmet need for new medicines in this indication. FX125L works in a different way (i.e. it has a different mechanism of action) to current marketed drugs and for this reason it may work better, have fewer side effects compared to the current medications used for treatment of asthma and may be used in addition to other medicines.
  

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  14/SC/1041

• Date of REC Opinion

  25 Jun 2014

• REC opinion

  Further Information Favourable Opinion