Efficacy-Safety Study of Sublingual Immunoth. With Depigmented-Polymerized Pollen Extracts to Treat Rhinoconjunctivitis - Full Text View

Sponsored by:	Laboratorios Leti, S.L.
Information provided by:	Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier:	NCT00550875

Purpose

As the principal objective of this study is to evaluate the efficacy and safety of the treatment measuring the changes in a symptom score, the patient will be asked to fill in a patient diary. This diary will evaluate the week before the patient comes back to receive the treatment. Nose (sneeze, blockage and running), eye (itching, redness and swelling) and chest (breathlessness, wheeze, chest tightness), are scored on a scale from The patient will be instructed to daily assess each one of the symptoms, recording them on an individual symptoms follow-up diary.

Condition	Intervention	Phase
Seasonal Allergic Rhinoconjunctivitis	Biological: Grass pollen allergenic extract (L. perenne-C. dactylon ) Biological: placebo	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomised Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Sublingual Immunotherapy With a Depigmented and Polymerized Grass Pollen Extracts in Patients Suffering From Allergic Rhinoconjunctivitis.

Further study details as provided by Laboratorios Leti, S.L.:

Estimated Enrollment:	90
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: Grass pollen allergenic extract (L. perenne-C. dactylon ) Sublingual. 2 drops/daily 1000 DPP/ml 2 years
2: Experimental 10* concentration of arm 1	Biological: Grass pollen allergenic extract (L. perenne-C. dactylon ) Sublingual. 2 drops/daily 10000 DPP/ml 2 years
3: Placebo Comparator	Biological: placebo Sublingual. 2 drops/daily 2 years

Detailed Description:

The study drug is a sublingual immunotherapy (vaccine) with allergenic extract of grass pollen (Lolium perenne (50%) + Cynodon dactylon (50%)). Sublingual immunotherapy has been available on the European market to treat patients with allergic rhinoconjunctivitis (itching, sneezing, stuffy nose, runny nose) for many years. In this study it will be used as drops under the tongue. At the beginning of the study, you will be given a card that documents that you are taking part. Please carry this with you at all times, in case treatment is necessary at another location. The drops will be given at two doses. The drops are held under the tongue for 2 minutes prior to swallowing.Sublingual Immunotherapy has been shown to be safe and effective in reducing the symptoms of allergic rhinoconjunctivitis (nasal allergy and allergy of the eyes).

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical history of allergic rhinoconjunctivitis and/or asthma due to hypersensitivity to grass mix Lolium perenne and Cynodon dactylon.
Male or female subjects between 18 and 50 years old
Positive skin tests to Lolium perenne and Cynodon dactylon: the wheal produced by the skin test by means of the prick-test technique must be equal or superior to the wheal produced by the positive control of prick test (histamine 10 mg/ml).
Presence of specific IgE to Lolium perenne and Cynodon dactylon (CAP greater than 17.5K u/L).
Female subjects must not be sexually active or must be following a medially accepted contraceptive method.
Pregnancy test negative

Exclusion Criteria:

Treatment with ß-blocking agents
Patients suffering from some pathology in which the adrenaline is contraindicated (hyperthyroidism, HTA, cardiopathy, etc.)
Autoimmune disease (thyroiditis, lupus, etc.)
Conditions in which the patient can not offer full co-operation, compliance or those with significant psychiatric disturbance.
Intolerance to aspirin.
Pregnant women or with pregnancy risk and breast-feeding women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550875

Locations

South Africa, Cape Town
Allergy Unit, UCT Lung Institute
Mowbray, Cape Town, South Africa, 7700

Sponsors and Collaborators

Laboratorios Leti, S.L.

Investigators

Principal Investigator:

Paul Potter, PhD, Prof.

UCT Lung Institute, Cape Town, South Africa

More Information

Study ID Numbers:	6078-PG-OSL-137
Study First Received:	August 22, 2007
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00550875
Health Authority:	South Africa: Department of Health; South Africa: Medicines Control Council; South Africa: National Health Research Ethics Council

Keywords provided by Laboratorios Leti, S.L.:

Seasonal Allergic rhinoconjunctivitis
Immunotherapy

Study placed in the following topic categories:

Hypersensitivity
Conjunctivitis, Allergic
Eye Diseases

Hypersensitivity, Immediate
Conjunctivitis
Conjunctival Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009