- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00407524
AKL 1 Asthma Study
December 4, 2006 updated by: University of Aberdeen
AKL1 Asthma Study - Randomised, Double-Blind, Placebo Controlled, Cross Over Study to Determine Safety and Efficacy of Oral AKL1 in Treating Patients With Asthma
This study aims to provide scientific evidence of the efficacy and safety of this agent as 'add-on' therapy for adult patients whose asthma remains uncontrolled on standard medication.
The aims are to assess the efficacy, safety and tolerability of AKL 1 companred to placebo in the treatment of asthma.
Study Overview
Study Type
Interventional
Enrollment
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aberdeen, United Kingdom, AB25 2AY
- ACCRU
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The patient is of either sex and between the ages of 18 to 70 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.
- The patient has a diagnosis of persistent chronic bronchial asthma (with reference to the Global Initiative for Asthma (GINA) guidelines, NIH, NHLBI. Global Initiative for asthma. NIH Publication no.96-3659B. Bethesda, MD:NID 1998) ).
- The patient has a FEV1 (% predicted) of > 60% at Visit 1.
- The patient has a positive reversibility test (or history of such) with >or equal 15% improvement in FEV1 from 15 to 30 minutes after inhalation of at least 200 ug of salbutamol (beta-2-adrenergic agonist administration) or PEF variability of 20% as described in current BTS/SIGN guidelines (British Thoracic Society, Scottish Intercollegiate Guideline Network. British Guidelines on the Management of Asthma. Thorax 2003;58:1-94.
- Females must be postmenopausal (> 1 year), surgically sterile or using adequate contraception (hormonal contraception, intrauterine device), not breast-feeding and have a negative serum pregnancy test.
- The patient is in satisfactory health with the exception of asthma as determined by the investigator on the basis of medical history and physical examination.
- In the investigator's judgment, the patient is able and willing to comply with Study Visits and procedures (including laboratory tests, lung function tests), and accurate and timely completion of an electronic asthma diary
Exclusion Criteria:
- The patient has poorly controlled asthma defined as requiring a course of oral or parenteral corticosteroids, admission to hospital for asthma (including treatment in an emergency room), or exacerbation of asthma in the three months prior to Visit 1 (in the investigator's judgment).
- Maintenance oral corticosteroid treatment.
- The patient has seasonal asthma alone.
- Use of unlicensed doses of inhaled corticosteroid medication (>2000mcg beclomethasone diproprionate/ day or equivalent).
- The patient has any known laboratory abnormality, which in the opinion of the investigator, would contraindicate study participation, including, blood urea nitrogen (BUN), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >or equal 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 prior to the Screening Visit.
- The patient has chronic heart failure class III or IV (New York Heart Association).
- The patient has a recent (less than six months) history of stroke, transient ischemic attack or myocardial infarction.
- The patient has a history of known alcohol or substance abuse within the one-year prior to Visit 1.
- 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 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
- The patient has significant uncontrolled chronic disease, such as hepatic or renal insufficiency, which in the opinion of the investigator, would contraindicate study participation or confound interpretation of the results.
- The patient has difficulty swallowing capsules or tablets, dysphagia or is unable to tolerate oral medication.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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vital signs
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mean improvements in morning prebronchodilator peak expiratory flow rate in the final week of twelve week active treatment
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improvement in forced expiratory volume in one second FEV one following twelve weeks of active treatment
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evaluation of adverse events
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clinial laboratory results including tests of liver function
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mike Thomas, University of Aberdeen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2003
Study Completion
March 1, 2005
Study Registration Dates
First Submitted
December 4, 2006
First Submitted That Met QC Criteria
December 4, 2006
First Posted (Estimate)
December 5, 2006
Study Record Updates
Last Update Posted (Estimate)
December 5, 2006
Last Update Submitted That Met QC Criteria
December 4, 2006
Last Verified
December 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03GP013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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