Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2013 by Medical Universtity of Lodz.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Medical Universtity of Lodz
Information provided by (Responsible Party):
Iwona Stelmach, Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT01052610
First received: January 12, 2010
Last updated: February 6, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of the trial is to asses the efficacy and safety of sublingual annual immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house dust mites.
| Condition | Intervention | Phase |
|---|---|---|
|
Bronchial Asthma Allergic Rhinitis |
Drug: sublingual house dust mites allergen extract Drug: placebo in sublingual applicator |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Assessment of Effectiveness and Safety of Annual Sublingual Immunotherapy in Children With Bronchial Asthma and/or Allergic Rhinitis Allergic to House Dust Mites |
Resource links provided by NLM:
Further study details as provided by Medical Universtity of Lodz:
Primary Outcome Measures:
- Clinical symptoms of asthma and allergic rhinitis and use of rescue medication [ Time Frame: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change of percent of regulatory lymphocytes in peripheral blood [ Time Frame: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT) ] [ Designated as safety issue: No ]
- assessment of inflammatory markers in exhaled breath condensate and FeNO [ Time Frame: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT) ] [ Designated as safety issue: No ]
- non-specific bronchial hyperreactivity with methacholine (PC20M), specific conjunctival provocation test [ Time Frame: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Active group
Group of children with bronchial asthma and/ or allergic rhinitis 6-18 years old receiving annually house dust mites sublingual allergen extract
|
Drug: sublingual house dust mites allergen extract
Staloral 300 IR, Stallergenes, France
|
|
Placebo Comparator: Placebo group
Group of children with bronchial asthma and/or allergic rhinitis 6-18 years old receiving placebo in sublingual applicator
|
Drug: placebo in sublingual applicator
placebo for Staloral 300 IR, Stallergenes, France
|
Detailed Description:
Allergen immunotherapy is currently the only one method of cause treatment of the IgE-dependent allergic diseases. Sublingual immunotherapy (SLIT) is the method which allows to give allergens via alternative oral route in patients home. Due to possibility of avoiding injection this therapy offers better relationship with pediatric patient. However efficacy and safety of sublingual immunotherapy are still important issues, especially in asthmatic children. The purpose of the trial is to asses the efficacy and safety of sublingual annual immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house dust mites.
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- patients with bronchial asthma and/or allergic rhinitis allergic to house dust mites first diagnosed at least 2 years before the study
Exclusion Criteria:
- active respiratory tract infection requiring antibiotic treatment within 4 weeks before the study
- hospitalisation due to asthma exacerbation during the 3 months before the first visit
- known contraindications of SIT according to the EAACI
- previous allergen immunotherapy
- use of systemic corticosteroids
- other clinically significant pulmonary, hematologic, hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or mental diseases or malignancy that either put the patient at risk when participating in the study or could influence the results of the study
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052610
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052610
Contacts
| Contact: Iwona Stelmach, MD, PhD, Prof | +48426895972 | alergol@kopernik.lodz.pl |
Locations
| Poland | |
| Department of Pediatrics and Allergy | Recruiting |
| Lodz, Poland, 93-513 | |
| Contact: Monika Bobrowska-Korzeniowska, MD, PhD 426895972 alergol@kopernik.lodz.pl | |
| Principal Investigator: Monika Bobrowska-Korzeniowska, MD, PhD | |
| Sub-Investigator: Agnieszka Brzozowska, MD, PhD | |
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
| Study Chair: | Iwona Stelmach, MD, PhD, Prof | Department of Pediatrics and Allergy |
More Information
No publications provided
| Responsible Party: | Iwona Stelmach, MD, PhD, Professor, Medical Universtity of Lodz |
| ClinicalTrials.gov Identifier: | NCT01052610 History of Changes |
| Other Study ID Numbers: | 502-12-760, 503-2056-1 |
| Study First Received: | January 12, 2010 |
| Last Updated: | February 6, 2013 |
| Health Authority: | Poland: Ministry of Health |
Keywords provided by Medical Universtity of Lodz:
|
SLIT bronchial asthma allergic rhinitis |
Additional relevant MeSH terms:
|
Asthma Rhinitis Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases |
Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on March 02, 2015