AsthmaPhase 2NCT00407524
AKL 1 Asthma Study
A Phase 2 study testing AKL 1 in people with Asthma, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- AKL 1
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2003to Mar 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Asthma
- Being tested
- AKL 1
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKL 1Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
mean improvements in morning prebronchodilator peak expiratory flow rate in the final week of twelve week active treatment
improvement in forced expiratory volume in one second FEV one following twelve weeks of active treatment
evaluation of adverse events
vital signs
clinial laboratory results including tests of liver function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startOct 2003
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Investigators
- Mike Thomas, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407524
- Sponsor's protocol ID
- 03GP013
- Status last verified
- Dec 2006
- First submitted
- 4 Dec 2006
- Last updated
- 5 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AKL1 Asthma Study - Randomised, Double-Blind, Placebo Controlled, Cross Over Study to Determine Safety and Efficacy of Oral AKL1 in Treating Patients With Asthma
- ClinicalTrials.gov ID
- NCT00407524
- Acronym / sponsor ID
- 03GP013
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- Oct 2003
- Study completion
- Mar 2005
- First posted
- 5 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AKL 1 | Drug | – |
Primary outcome
mean improvements in morning prebronchodilator peak expiratory flow rate in the final week of twelve week active treatment
improvement in forced expiratory volume in one second FEV one following twelve weeks of active treatment
evaluation of adverse events
vital signs
clinial laboratory results including tests of liver function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2006.
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Thomas principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AKL 1 in people with Asthma, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean improvements in morning prebronchodilator peak expiratory flow rate in the final week of twelve week active treatment. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2006.