Efficacy of 2LALERG (Homeopathic Drug) in Allergic Rhinitis Related to Grass Pollen

Phase 4

Completed

Conditions: Seasonal Allergy

Interventions: Drug: Placebo
Drug: 2LALERG

Registration Number: NCT02690935

Lead Sponsor: Labo'Life

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 102

Inclusion Criteria

Age ≥18 years, male and female
Woman of childbearing age using effective contraceptive means
Patient having the faculties to understand and respect the constraints of the study
Symptomatic since at least two seasons and 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 positive if at least class 3 (≥ 3.5 kU / L); these tests must have been performed at the latest at the first screening visit
Signature of the Informed Consent Form

Exclusion Criteria

Pregnant woman or woman wishing to become pregnant
Breastfeeding woman
Patient with an acute exacerbation of allergic rhinitis
Patient with uncontrolled asthma
Immunotherapy received within the last two years
Patient with a known lactose intolerance
Patient who participated in a clinical study in the previous three months
Patient who is not sufficiently motivated to engage on a follow-up period of 6 months or more, unable to complete the patient diary, or likely to travel or to move before the end of the study,
Patient taking nasal or bronchial inhaled corticosteroids on a long term basis (intermittent consumption during the season is permitted provided it is mentioned in the patient's records)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Non-impregnated lactose saccharose globules (380 mg/capsule)
2LALERG	2LALERG	Interleukin 1: 17 CH Interleukin 4: 17-27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH Impregnated on lactose saccharose globules (380 mg/capsule)

Primary Outcome Measures

Name	Time	Method
Area Under the Curve [AUC](Total Score of Symptoms Taking Into Account the Total 5 Symptom Score (T5SS) and Consumption of Rescue Medications (RM) on the Y-axis, and Time on X Axis)	Up to Month 6 (end of pollen season)	Area under the curve \[AUC\] (total score of symptoms taking into account the Total 5 Symptom Score (T5SS) and consumption of rescue medications (RM) on the Y-axis versus time on X axis). T5SS was the sum of the 5 individual scores (min-max=0-15). It was corrected each day as a function of consumption of rescue medications (RM): oral antihistamine (+2 points), local treatment (nasal or eye; +1 point), ocular cromoglycate (+1 point) and nasal topical corticosteroids (+1 point). An increase in the total corrected score was considered as a worsening of the allergic symptoms.

Secondary Outcome Measures

Name	Time	Method
Quality of Life During the Whole Period of Observation	QoL scores were assessed daily for up to 6 months	This is the mean of the score to 3 daily quality of life questions: 1) Did you sleep well (0 to 3), 2) Are you able to work (0 to 3), 3) How do you feel today (0 to 3). The minimum daily score is 0 (good quality of life) and the maximum is 9 (bad quality of life). The mean of the daily scores was calculated over the whole period of observation (up to 6 months) for each patient.