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Efficacy of 2L®ALERG in Seasonal Allergic Rhinitis
NCT02690935Phase 4
Key facts
- Status
- Completed
- Start
- Mar 2016
- Primary completion
- Apr 2017
- Countries
- 1
- Sponsor
- Labo'Life
- Modality
- Nucleic Acid Therapeutics, Recombinant Proteins and Enzymes, Small Molecules
- Drugs
- 2LALERG
- Conditions
- allergic rhinitis (AR)allergic rhinoconjunctivitis (ARC)
01
Overview
Phase 4, randomised, double-blind trial in allergic rhinitis (AR) and allergic rhinoconjunctivitis (ARC) comparing 2LALERG with Placebo (2 arms). Primary endpoint: Area Under the Curve of Total Score of Symptoms. Started Mar 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
2LALERG
2L®ALERG (Homeopathic Drug) 1 capsule daily
Placebo
Placebo 1 capsule daily
03
Who it enrols
Adult patients with seasonal allergy to grass pollen, symptomatic for at least two seasons, confirmed by positive skin test or IgE. Excludes patients with uncontrolled asthma, recent immunotherapy, or long-term corticosteroid use.
04
Endpoints
Primary
Area Under the Curve of Total Score of Symptoms
Secondary
Quality of Life
Rescue Medication Intake
Safety (Adverse Events)
05
Results
Not all primary endpoints met
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