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Treatment With AKL1 in Obstructive Airways Disease (The TAKL Study) (TAKL)

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ClinicalTrials.gov Identifier: NCT00920127
Recruitment Status : Unknown
Verified August 2011 by University of East Anglia.
Recruitment status was:  Active, not recruiting
First Posted : June 15, 2009
Last Update Posted : August 5, 2011
Sponsor:
Information provided by:
University of East Anglia

Tracking Information
First Submitted Date  ICMJE June 12, 2009
First Posted Date  ICMJE June 15, 2009
Last Update Posted Date August 5, 2011
Study Start Date  ICMJE June 2009
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2009)
The change in the Leicester Cough Questionnaire (LCQ) score [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2009)
  • St Georges Respiratory Questionnaire (SGRQ) score [ Time Frame: 8 weeks ]
  • EQ-5D score [ Time Frame: 8 weeks ]
  • Spirometry (FEV1, FVC, PEF, FEF25-75 predicted) [ Time Frame: 8 weeks ]
  • Impulse Oscillometry [ Time Frame: 8 weeks ]
  • Differential spontaneous sputum cell count; TNFα,IL-8, IL-10 concentration [ Time Frame: 8 weeks ]
  • Modified MRC dyspnoea score [ Time Frame: 8 weeks ]
  • 6 minute walk [ Time Frame: 8 weeks ]
  • Blood haematology and biochemistry [ Time Frame: 10 weeks ]
  • Drug related adverse events [ Time Frame: 10 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment With AKL1 in Obstructive Airways Disease (The TAKL Study)
Official Title  ICMJE An Investigation of the Safety and Efficacy of Oral AKL1 in Patients Diagnosed With Obstructive Lung Disease
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obstructive Lung Disease
  • Chronic Obstructive Pulmonary Disease
  • Asthma
Intervention  ICMJE Dietary Supplement: AKL1

Each dose of AKL1 or placebo will consist of two capsules which will be swallowed twice daily for 8 weeks.

The morning dose of study medication should be taken at approximately the same time each morning between 7:00 am and 10:00 am and should consist of two 500 mg capsules and then repeated between 7.00 pm and 10 pm.

Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: AKL1
  • Active Comparator: AKL1
    Intervention: Dietary Supplement: AKL1
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 12, 2009)
164
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females, aged between 18 to 80 years, inclusive
  • The patient has received verbal and written study information, all questions have been answered satisfactorily and a consent form has been personally signed and dated by the patient and the investigator
  • A diagnosis of obstructive lung disease (with reference to the - International Primary Care Respiratory Group (IPCRG) Guidelines)(4). This being evidenced as a post bronchodilator ratio of FEV1/FVC < 0.7 at Visit 1 or 2 The patient has a post bronchodilator FEV1 of greater than 40% and less than 80% at Visit 1 or 2
  • Patients have a history of regular sputum production (> 3 days per week)
  • LCQ score of <17 (higher score indicates improvement).
  • A MRC dyspnoea score of 3 or more
  • Females must be post menopausal (> 1 year), surgically sterilised or using adequate hormonal contraception, intrauterine device), not breast feeding and have a negative serum pregnancy test
  • The patient must have a satisfactory health with the exception of obstructive lung disease as determined by the investigator on the basis of medical history and physical examination
  • In the Investigator's judgement, the patient is able and willing to comply with study visits and procedures (including laboratory tests, lung function tests).
  • Subjects must be able to demonstrate ability to use salbutamol MDI during the screening period

Exclusion Criteria:

  • The patient has currently poorly controlled disease defined as requiring a course of oral or parenteral corticosteroids or an exacerbation of their obstructive lung disease in the three months prior to Visit 2.
  • The patient has had a recent change in maintenance therapy (i.e. within 6 weeks)
  • Maintenance oral corticosteroid treatment or use of unlicensed doses of inhaled corticosteroid medication (>2000mcg beclomethasone diproprionate/ day or equivalent)
  • The patient has seasonal disease alone
  • The patient has any known laboratory abnormality, which in the opinion of the investigator, would contraindicate study participation, including, aspartate aminotransferase (AST) or alanine aminotransferase (ALT)greater/equal to 1.5 x upper limit of normal (ULN) or creatinine > 1.5 mg/dL
  • The patient is unable to discontinue short-acting beta-2-adrenergic agonists for at least 4 hours, long-acting beta agonists (12 hours) and tiotropium (24 hours) prior to Visit 2 (Week 0)
  • The patient has chronic heart failure class III or IV (New York Heart Association) or a recent (less than six months) history of stroke, transient ischemic attack or myocardial infarction
  • The patient is not able to follow study procedures (e.g., language problems, psychological disorders) or is considered to be non-compliant according to the investigator.
  • The patient has a history of known alcohol or substance abuse (excluding cigarettes) within the one-year prior to Visit 1
  • The patient has an active malignancy of any type or history of a malignancy (with the exception of patients with malignancy surgically removed with no evidence of recurrence within five years before enrolment, and patients with history of treated basal cell carcinoma)
  • The patient has any other severe or acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. Subjects with a malignancy and who are currently undergoing radiation therapy or have had chemotherapy within 5 years.
  • The patient has difficulty swallowing capsules or tablets, dysphagia or is unable to tolerate oral medication
  • The patient has been previously admitted to the study or currently participating or have recently participated in another trial with an investigational drug within 90 days of the start of this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00920127
Other Study ID Numbers  ICMJE 32227/0001/001
EudraCT: 2222 - 222222-22
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Andrew M Wilson, University of East Anglia
Study Sponsor  ICMJE University of East Anglia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Wilson, MD, MRCP (UK) University of East Anglia
PRS Account University of East Anglia
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP