House Dust Mite SLIT in Elderly Patients

NCT ID: NCT01605760

Last Updated: 2012-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-03-31

Brief Summary

The safety and efficacy of specific sublingual immunotherapy for house dust mite allergens in patients over 60 years of age with allergic rhinitis and a confirmed allergy to house dust mites were the focus of the stu First, 111 patients, ages 60-75 years, with allergic rhinitis and with a confirmed allergy to D. pteronyssinus and D. farinae by the use of skin prick tests, serum-specific IgE and nasal provocation tests were included. Patients were individually randomised to groups: active or placebo using a double-blind method. A total of 51 subjects in the sublingual allergen-specific immunotherapy (SLIT) group (Staloral 300R, Stallergens, France) and 57 in the placebo group were monitored for three years. The patients had to record on a diary card whenever they used anti-allergic medications.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

non immunotherapy treatment

Group Type: NO_INTERVENTION

immunotherapy Staloral

Intervention Type: DRUG

Staloral (R) 300 is a sublingual solution of allergen extracts for allergen immunotherapy. During a 16 day incrementally increasing dose period, patients took daily increasing doses period, patients took 1-8 drops of the 100 IR/ml extract during the first 8 days. Then, on days 9-16, patients took 1-8 drops of the 300 IR/ml extract. Next, patients received maintenance treatment consisting of five applications of eight drops (equivalent to 0.5 mL) of 300 IR/mL extract five times a week. The mean duration of the treatment was 28.2 months (range: 3-36 months).

sublingual immunotherapy course

Group Type: ACTIVE_COMPARATOR

immunotherapy Staloral

Intervention Type: DRUG

Staloral (R) 300 is a sublingual solution of allergen extracts for allergen immunotherapy. During a 16 day incrementally increasing dose period, patients took daily increasing doses period, patients took 1-8 drops of the 100 IR/ml extract during the first 8 days. Then, on days 9-16, patients took 1-8 drops of the 300 IR/ml extract. Next, patients received maintenance treatment consisting of five applications of eight drops (equivalent to 0.5 mL) of 300 IR/mL extract five times a week. The mean duration of the treatment was 28.2 months (range: 3-36 months).

Interventions

immunotherapy Staloral

Staloral (R) 300 is a sublingual solution of allergen extracts for allergen immunotherapy. During a 16 day incrementally increasing dose period, patients took daily increasing doses period, patients took 1-8 drops of the 100 IR/ml extract during the first 8 days. Then, on days 9-16, patients took 1-8 drops of the 300 IR/ml extract. Next, patients received maintenance treatment consisting of five applications of eight drops (equivalent to 0.5 mL) of 300 IR/mL extract five times a week. The mean duration of the treatment was 28.2 months (range: 3-36 months).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects with allergic rhinitis who fulfilled the ARIA criterion and had a positive skin prick test (SPT), were positive for specific immunoglobulin E (sIgE) and had positive nasal provocation tests (NPTs) by Dermatophagoides pteronyssinus (Der p) and Dermatophagoides farinae (Der f) were included in the study

Exclusion Criteria

• Patients with any of the following characteristics were excluded:

• hypersensitivity to other allergens,
• non-allergic rhinitis (especially senile or vasomotor rhinitis) or
• severe non-stable diseases (especially bronchial asthma). However, stable coronary disease, diabetes, arterial hypertension and well-controlled, mild or atopic bronchial asthma were permitted.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Silesia

OTHER

Sponsor Role: lead

Responsible Party

Andrzej Bozek

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Allergology Outpatient Clinic

Zabrze, , Poland

Countries

Poland

References

Bozek A, Starczewska-Dymek L, Jarzab J. Prolonged effect of allergen sublingual immunotherapy for house dust mites in elderly patients. Ann Allergy Asthma Immunol. 2017 Jul;119(1):77-82. doi: 10.1016/j.anai.2017.05.012.

Reference Type: DERIVED

PMID: 28668244 (View on PubMed)

Bozek A, Ignasiak B, Filipowska B, Jarzab J. House dust mite sublingual immunotherapy: a double-blind, placebo-controlled study in elderly patients with allergic rhinitis. Clin Exp Allergy. 2013 Feb;43(2):242-8. doi: 10.1111/cea.12039.

Reference Type: DERIVED

PMID: 23331565 (View on PubMed)

Other Identifiers

657898/2008

Identifier Type: -

Identifier Source: org_study_id