Allergic ConditionsPhase 4korLAISNCT02277483
Efficacy and Safety of LAIS® Mites Sublingual Tablets
A Phase 4 study testing LAIS® in people with Allergic Conditions, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Evaluation of the efficacy and safety of SLIT with LAIS® Mites Sublingual tablets compared to standard drug treatment in patients aged over 60 years suffering from house dust mite (HDM) induced allergic rhino-conjunctivitis with/without asthma. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Allergic Conditions
- What is being tested?
- LAIS®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Dec 2016
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male patients aged 60 years or more with a history of at least two years of house dust mite (HDM) induced allergic rhinitis and/or allergic rhinoconjunctivitis with or without mild to moderate controlled asthma upon exposure to house dust mite [From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2007.
- Clinically relevant sensitization to mites.
- Positive clinical history of allergy due to house dust mite (HDM), proven by- The majority of perennial clinical symptoms appearing mostly related to indoor mites allergens
- Specific Immunoglobulin E reactivity to mites allergens (ImmunoCAP>0.35 Ku/L)
- Positive skin prick test (wheal diameter> 3mm, negative control < 2mm)
- Retrospective Total Symptom Score (RRTSS) referred to the previous winter season greater than or equal to 8
- Compliance and ability of the patient to complete a diary card for self-evaluation of the symptoms and anti-symptomatic medication
- Signed and dated patient's Informed Consent
Who cannot join
- Simultaneous participation in other clinical trials
- Previous immunotherapy with mite allergens or cross reacting allergens within the last 5 years
- Ongoing immunotherapy with any allergen
- Patients being in any relationship or dependency with the sponsor and/or investigator
- Other reasons contra-indicating an inclusion into the trial according to the investigator's estimation (e.g. poor compliance, inability of the patient to understand study documents and instructions)
- Predominant seasonal allergic rhinitis
Show all 23Show fewer
- Patients with clinically relevant sensitization to seasonal aero-allergens occurring during the study period may not be included. Also patients with clinically relevant sensitization to perennial allergens like animal dander may not be included
- Uncontrolled asthma
- Chronic asthma or emphysema, particularly with a forced expiratory volume <70% of the predicted value and /or <70% of the individual optimum value
- Infections of the oral cavity with severe symptoms
- Patients with Galactose-intolerance, Lactase-deficiency, Glucose-Galactose-malabsorption
- Active tuberculosis
- Generally inflammatory as well as severe acute and chronic inflammatory diseases
- Irreversible secondary disorders at the target organ (e.g. emphysema, bronchiectasis)
- Immune deficiency (for example induced by immunosuppressive drugs)
- Physician diagnosed diseases of the liver, spleen, nervous system, thyroidal gland as well rheumatic diseases, based on an autoimmune mechanism,
- Malignancy
- Alcohol abuse as well as drug and / or medication abuse
- Patients treated with contra-indicated drugs
- Contra-indication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism)
- Completed or ongoing long-term treatment with tranquilizer or psycho active drugs
- Completed or ongoing treatment with anti-Specific Immunoglobulin E-antibody
- Uncontrolled asthma according to GINA guideline criteria
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jung-Won Park
Seoul
JUNG WON PARK, M.D.,ph.D, 82-2-2228-1966
About this study
Official title: Efficacy and Safety of LAIS® Mites Sublingual Tablets in Patients Aged Over 60 Years Suffering From House Dust Mite-induced Allergic Rhino-conjunctivitis With/Without Asthma
Evaluation of the efficacy and safety of SLIT with LAIS® Mites Sublingual tablets compared to standard drug treatment in patients aged over 60 years suffering from house dust mite (HDM) induced allergic rhino-conjunctivitis with/without asthma.
Read the detailed description
The Total combined score (TCS), taking into account the rhinoconjunctivitis total symptom score (RTSS) and the total rescue medication score (RTMS), in the maximum expected mites exposition period (V4-V5) For the RTSS and the RTMS, the daily values as determined by the patients in their diary card are collected during the observation period over 30 days. Then, the mean daily scores during that period are calculated for both parameters.
- Conditions
- Allergic Conditions
- Being tested
- LAIS®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAIS®Drug
Also called active treatment
10 X 1,000 / twice a week
| Study group | Role | What they receive |
|---|---|---|
| active treatment | Active comparator | LAIS® Mites Sublingual tablets + rescue medication Receives: Drug: LAIS® |
| control | No intervention | Rescue medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total combined score (TCS)
TCS = rhinoconjunctivitis total symptom score (RTSS) and the total rescue medication score (RTMS)
Measured: up to 48 weeks
Secondary outcomes (1)
sublingual immunotherapy
usage of the Total Rescue Medication Score (RTMS)
Measured: up to 48weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ConditionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hae-Sim Park, Ajou University School of Medicine
- Investigators
- hae-sim park, professor, Principal investigator, Department of internal medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277483
- Sponsor's protocol ID
- MED-CT4-14-159
- Acronym
- korLAIS
- Status last verified
- Jun 2015
- First submitted
- 20 Oct 2014
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of LAIS® Mites Sublingual Tablets in Patients Aged Over 60 Years Suffering From House Dust Mite-induced Allergic Rhino-conjunctivitis With/Without Asthma
- ClinicalTrials.gov ID
- NCT02277483
- Acronym / sponsor ID
- korLAIS / MED-CT4-14-159
- Conditions
- Allergic Conditions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 Oct 2014 (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.
Evaluation of the efficacy and safety of SLIT with LAIS® Mites Sublingual tablets compared to standard drug treatment in patients aged over 60 years suffering from house dust mite (HDM) induced allergic rhino-conjunctivitis with/without asthma.
Detailed description
The Total combined score (TCS), taking into account the rhinoconjunctivitis total symptom score (RTSS) and the total rescue medication score (RTMS), in the maximum expected mites exposition period (V4-V5) For the RTSS and the RTMS, the daily values as determined by the patients in their diary card are collected during the observation period over 30 days. Then, the mean daily scores during that period are calculated for both parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active treatment | Active comparator | Drug: LAIS®LAIS® Mites Sublingual tablets + rescue medication |
| control | No intervention | –Rescue medication |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female or male patients aged 60 years or more with a history of at least two years of house dust mite (HDM) induced allergic rhinitis and/or allergic rhinoconjunctivitis with or without mild to moderate controlled asthma upon exposure to house dust mite [From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2007.
- Clinically relevant sensitization to mites.
- Positive clinical history of allergy due to house dust mite (HDM), proven by- The majority of perennial clinical symptoms appearing mostly related to indoor mites allergens
- Retrospective Total Symptom Score (RRTSS) referred to the previous winter season greater than or equal to 8
- Compliance and ability of the patient to complete a diary card for self-evaluation of the symptoms and anti-symptomatic medication
Key exclusion criteria (23 listed)
- Simultaneous participation in other clinical trials
- Previous immunotherapy with mite allergens or cross reacting allergens within the last 5 years
- Ongoing immunotherapy with any allergen
- Patients being in any relationship or dependency with the sponsor and/or investigator
- Other reasons contra-indicating an inclusion into the trial according to the investigator's estimation (e.g. poor compliance, inability of the patient to understand study documents and instructions)
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 |
|---|---|---|
| LAIS®Also: active treatment10 X 1,000 / twice a week | Drug | active treatment |
Primary outcome
Total combined score (TCS)
Time frame: up to 48 weeks
TCS = rhinoconjunctivitis total symptom score (RTSS) and the total rescue medication score (RTMS)
1 secondary outcome
sublingual immunotherapy
Time frame: up to 48weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
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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.
hae-sim park, professor principal investigator
Department of internal medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LAIS® in people with Allergic Conditions, run by Ajou University School of Medicine at 1 site in South Korea.
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 23 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: status not confirmed, as of the sponsor's last update on 23 Jun 2015. 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yun-kyoung kim, Nr (82-31-219-4467, forsake326@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total combined score (TCS) (time frame: up to 48 weeks). 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 23 Jun 2015.