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Trial record 19 of 32 for:    Interleukin-10

Efficacy of 2LALERG (Homeopathic Drug) in Allergic Rhinitis Related to Grass Pollen (LLB-2016-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02690935
Recruitment Status : Completed
First Posted : February 24, 2016
Results First Posted : December 15, 2017
Last Update Posted : December 15, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Seasonal Allergy Drug: 2LALERG Drug: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : March 2016
Actual Primary Completion Date : April 7, 2017
Actual Study Completion Date : April 7, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Hay Fever

Arm Intervention/treatment
Experimental: 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)

Homeopathic drug
Other Name: Immunotherapy

Placebo Comparator: Placebo
Non-impregnated lactose saccharose globules (380 mg/capsule)
Drug: Placebo

Primary Outcome Measures :
  1. 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) [ Time Frame: 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 :
  1. Quality of Life During the Whole Period of Observation [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02690935

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Linkebeek, Belgium, 1630
Sponsors and Collaborators
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Principal Investigator: Stéphane Heijmans, MD ResearchLink
  Study Documents (Full-Text)

Documents provided by Labo'Life:
Study Protocol  [PDF] February 4, 2016
Statistical Analysis Plan  [PDF] February 29, 2016

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Responsible Party: Labo'Life Identifier: NCT02690935     History of Changes
Other Study ID Numbers: LLB-2016-01
First Posted: February 24, 2016    Key Record Dates
Results First Posted: December 15, 2017
Last Update Posted: December 15, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Labo'Life:
grass pollen
quality of life

Additional relevant MeSH terms:
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Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Immune System Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate