Efficacy of 2LALERG (Homeopathic Drug) in Allergic Rhinitis Related to Grass Pollen
Condition: Seasonal Allergy
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Hypersensitivity
Intervention: 2LALERG; Placebo
Intervention description: Homeopathic drug; Placebo
Intervention MeSH terms: Immunomodulating Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: grass pollen; homeopathy; placebo; quality of life

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.
    

Eligibility criteria:

        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)