Seasonal Allergy Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled Study to Measure 2L®ALERG (Homeopathic Drug) Efficacy on Symptoms of Allergic Rhinitis and Allergic Rhinoconjunctivitis in Patients With a Seasonal Allergy to Grass Pollen
The primary objective of this study is to demonstrate the superiority of 2L®ALERG over
placebo in terms of efficacy on the symptoms of allergic rhinitis and allergic
rhinoconjunctivitis in patients with seasonal allergy to grass pollen, corrected according to
rescue medication intake. The secondary objectives are to compare the allergy symptoms, the
rescue medication intake, the quality of life and the safety in patients treated with
2L®ALERG or with a placebo.
This is a multicentre, randomized, double-blind, two-parallel group, interventional
placebo-controlled study with a notified homeopathic medication, marketed since 2002.
Fifty patients will be recruited per group to achieve 40 cases completed per group, i.e., a
total of 100 patients included for 80 cases completed.
Screening will be done before the peak of pollination and the treatment will be set up two
months before traditional pollen peak, then visits at 3 months and 6 months, or end of the
peak.
The treatment will consist of 1 capsule daily, fasting morning, following the numerical order
of 1 to 10 capsules for 6 months.
The placebo will have the same form, colour, taste and aspect. The allowed concomitant
treatments are the already established treatments for associated pathologies not liable to
have an impact on the proper conduct of the study and the rescue medications allowed in the
first-line adjuvant treatment (oral or topical antihistamines [nasal or eye] and eye
cromoglycate, topical nasal corticosteroids [in case of failure or insufficiency of those
above]).
The prohibited treatments are the oral or injectable corticosteroids and the
anti-leukotrienes.
The primary objective of this study is to demonstrate the superiority of 2L®ALERG over
placebo in terms of efficacy on the symptoms of allergic rhinitis and allergic
rhinoconjunctivitis in patients with seasonal allergy to grass pollen, corrected according to
rescue medication intake. The secondary objectives are to compare the allergy symptoms, the
rescue medication intake, the quality of life and the safety in patients treated with
2L®ALERG or with a placebo.
This is a multicentre, randomized, double-blind, two-parallel group, interventional
placebo-controlled study with a notified homeopathic medication, marketed since 2002.
Fifty patients will be recruited per group to achieve 40 cases completed per group, i.e., a
total of 100 patients included for 80 cases completed.
Screening will be done before the peak of pollination and the treatment will be set up two
months before traditional pollen peak, then visits at 3 months and 6 months, or end of the
peak.
The treatment will consist of 1 capsule daily, fasting morning, following the numerical order
of 1 to 10 capsules for 6 months.
The placebo will have the same form, colour, taste and aspect. The allowed concomitant
treatments are the already established treatments for associated pathologies not liable to
have an impact on the proper conduct of the study and the rescue medications allowed in the
first-line adjuvant treatment (oral or topical antihistamines [nasal or eye] and eye
cromoglycate, topical nasal corticosteroids [in case of failure or insufficiency of those
above]).
The prohibited treatments are the oral or injectable corticosteroids and the
anti-leukotrienes.
The following demographic data will be collected during the first visit: date of birth,
gender, ethnic group, weight, height, smoking habits and alcohol use status.
Medical history, treatment history, concomitant treatments and patient's physical examination
will also be documented during V0.
The allergy must be confirmed by positive skin test and/or the presence of IgE for grasses
(prick test defined as positive if higher than or equal to half the negative control; IgE are
positive if at least class 3 (≥ 3.5 kU / L); these tests must have been made at the latest
during the first visit.
A patient diary will be given to each patient:
- For evaluation of the total 5 symptoms score T5SS and rescue medication RS, it is
essential that patients note every day the symptoms (sneezing, rhinorrhoea, nasal
pruritus, itching and/or eye tearing and nasal obstruction) intensity, and the rescue
medications, in their patient diary.
- It is also essential that the patient takes note every day of his/her QoL by filling in
three questions included in his/her diary card: Did you sleep well? - Can you work
normally? - How do you feel?
- It is also imperative that patients note the date of the start of treatment and the date
of onset of symptoms.
This patient diary will be given to the patient at each visit, and will be brought back at
the next visit, it will be reviewed and validated by the investigator and will be part of the
Case Report Form.
All relevant (related to allergy) concomitant medications taken by the patient during the
study period will be recorded at each visit in the CRF.
The AEs and SAEs will be recorded at V1 and V2 in order to assess safety.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01731249 -
Efficacy and Safety Study of a Sublingual Immunotherapy Solution to Treat Patients Suffering From Birch Pollen Allergic Rhinoconjunctivitis
|
Phase 3 |