Trials / Unknown
UnknownNCT02277483
Efficacy and Safety of LAIS® Mites Sublingual Tablets
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
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Ajou University School of Medicine · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LAIS® | 10 X 1,000 / twice a week |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2016-07-01
- Completion
- 2016-12-01
- First posted
- 2014-10-29
- Last updated
- 2015-06-23
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02277483. Inclusion in this directory is not an endorsement.