Asthma Clinical Trial
Official title:
An Investigation of the Safety and Efficacy of Oral AKL1 in Patients Diagnosed With Obstructive Lung Disease
Obstructive airways disease is a very common condition. This condition includes patients
with asthma, chronic obstructive pulmonary disease (COPD), emphysema or chronic bronchitis.
Some patients with obstructive airways disease have problems with long term breathlessness,
wheeze and cough with or without sputum production. Currently the researchers give
treatments - usually inhalers - which are designed to open the airways and reduce the
breathlessness and wheeze. Despite these available treatments many patients still have
continuing symptoms.
Anecdotal clinical evidence suggested that a herbal remedy (called AKL1) has beneficial
effects in respiratory conditions, with patients diagnosed as having both asthma and COPD
reporting reduced symptoms including breathlessness and cough and reduced frequency of
attacks.The purpose of this study is to confirm whether AKL1 does indeed have a meaningful
benefit to patients with obstructive airways disease. The researchers will mainly be
measuring any effect of AKL by assessing any change in trial subjects' coughs, using a
questionnaire, but the researchers will also looking at breathing tests, walking tests,
blood and sputum tests.
The outcomes of care for obstructive airways disease in the UK and other countries fail to
meet guideline targets, with high levels of avoidable morbidity and avoidable mortality.
Obstructive lung disease is an encompassing term for a condition that includes patients with
a reversible (asthma) or non reversible (chronic obstructive pulmonary disease) component to
their lung function.
AKL1 is a novel pharmaceutical agent derived from a combination of botanical products
developed as a treatment for obstructive lung disease (asthma and COPD). The botanical
product contains a synthetically-derived phytochemical component of Picrorrhiza kurroa,
apocynin, together with standardized extracts of Picrorrhiza kurroa, Zingiber officinale and
Ginkgo biloba that have previously been marketed as a health food supplements. Recent
evidence suggests that Ginkgo biloba reduces inflammatory (protein kinase C positive ie
eosinophils and neutrophils) cells in induced sputum which given in addition to inhaled
corticosteroids to asthmatic patients. Anecdotal clinical evidence suggests that the
botanical product has significant activity in respiratory conditions, with patients
diagnosed as having obstructive lung disease (asthma and COPD) reporting reduced symptoms
including breathlessness and cough, reduced frequency of attacks, reduced dependence on
bronchodilators and ability to reduce inhaled corticosteroids dose.
We have completed a pilot study investigating the efficacy and safety of AKL1 as 'add-on'
therapy for adult patients diagnosed as having obstructive lung disease whose symptoms
remained uncontrolled on standard medication. Whilst there was no significant differences in
lung function, there were trends to clinical improvements in the patient-centered outcomes
e.g. cough, health status and exacerbation frequency. Hence a larger adequately powered
study is needed to investigate these outcomes further.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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