Treatment with AKL1 in obstructive airways diease (The TAKL Study)

• Research type

  Research Study

• Full title

  An Investigation of the Safety and Efficacy of Oral AKL1 in Patients Diagnosed with Obstructive Lung Disease

• Sponsor organisation

  AKL Technologies Ltd.

• Eudract number

  2222 - 222222-22

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  The proposed study is designed to investigate the effect of AKL1 (pharmaceutical agent derived from a combination of botanical products developed as a treatment for Asthma) when given in addition to usual treatment in patients with obstructive airways disease (asthma and chronic obstructive pulmonary disease (COPD)). A small study suggests that it may have beneficial effects in patients in terms of their cough and we would like to test this in a larger study.One hundred and sixty-four patients with obstructive airways disease will be recruited from GP clinics in Norfolk. The patients will receive either AKL1 or matching dummy treatment in addition to their usual treatment for 8 weeks. We are mainly looking to see if there is an effect of ALK1 in terms of patients' cough and we will assess this by using a standardised cough questionnaire. We will also measure breathing tests, breathlessness scores, the distance patients can walk in 6 minutes, the levels of inflammatory chemicals in the patients' sputum and other questionnaires designed to assess their quality of life. The safety of the treatment will be assessed by measuring blood tests and recording any side effects the patients may have.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  08/H0305/54

• Date of REC Opinion

  15 Dec 2008

• REC opinion

  Further Information Favourable Opinion