Efficacy-safety Study of Sublingual Immunotherapy With Depigmented-polymerized Pollen Extracts to Treat Rhinoconjunctivitis

NCT00550875 | Completed Phase 2 DMC

• 1 other identifier: 6078-PG-OSL-137
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Rhinoconjunctivitis

Keywords

Allergic rhinoconjunctivitis,; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• AUC for Symptom Score and Mean Symptom Score in the pollen period.

  2 years

Secondary Outcomes (1)

• Symptom Score, Immunological evaluation,Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Adverse events

  2 years

Study Arms (3)

1

EXPERIMENTAL

Biological: Grass pollen allergenic extract (L. perenne-C. dactylon )

2

EXPERIMENTAL

10\* concentration of arm 1

Biological: Grass pollen allergenic extract (L. perenne-C. dactylon )

3

PLACEBO COMPARATOR

Biological: placebo

Interventions

Grass pollen allergenic extract (L. perenne-C. dactylon ) BIOLOGICAL

Sublingual. 2 drops/daily 1000 DPP/ml 2 years

1

placebo BIOLOGICAL

Sublingual. 2 drops/daily 2 years

3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratorios Leti, S.L.: lead

Study Sites (1)

Allergy Unit, UCT Lung Institute

Mowbray, Cape Town, 7700, South Africa

Location

Study Officials

• Paul Potter, PhD, Prof.

  UCT Lung Institute, Cape Town, South Africa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 22, 2007
• First Posted: October 30, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 13, 2011

Record last verified: 2011-07

Locations

ZA (1)