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

This is an interventional treatment trial for Obstructive Lung Disease focused on measuring AKL1, COPD Read More

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.