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

NCT02690935 | Completed Phase 4 Results

• 1 other identifier: LLB-2016-01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Allergy

Keywords

grass pollen; homeopathy; placebo; quality of life

Outcome Measures

Primary Outcomes (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)

  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.

  Up to Month 6 (end of pollen season)

Secondary Outcomes (1)

• Quality of Life During the Whole Period of Observation

  QoL scores were assessed daily for up to 6 months

Study Arms (2)

2LALERG

EXPERIMENTAL

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)

Drug: 2LALERG

Placebo

PLACEBO COMPARATOR

Non-impregnated lactose saccharose globules (380 mg/capsule)

Drug: Placebo

Interventions

2LALERG DRUG

Homeopathic drug

Also known as: Immunotherapy

2LALERG

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Labo'Life: lead

Study Sites (1)

ResearchLink

Linkebeek, 1630, Belgium

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Limitations and Caveats

1. Allergy cases were mainly prevalent and chronic. 2. Many concomitant drugs were taken 3. Patients were older in this trial compared to Van der Brempt et al. (2011)

Results Point of Contact

• Title: Dr. Stephane Heijmans
• Organization: ECSOR

Jacques.Bruhwyler@ecsor.com

3267444093

Study Officials

• Stéphane Heijmans, MD

  ResearchLink

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 24, 2016
• Study Start: March 1, 2016
• Primary Completion: April 7, 2017
• Study Completion: April 7, 2017
• Last Updated: September 30, 2020
• Results First Posted: December 15, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)