Molecular and Cellular Mechanism in the Course of Immunotherapy With a Phleum Pratense Oral Lyophilisate

NCT01854736 | Completed Phase 4

• 2 other identifiers: GT-242012-005092-14
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief Summary

This trial is an exploratory randomised, parallel-group, double-blind, placebo- controlled, national, single-centre trial. The trial will be initiated before 2013 grass pollen season and subjects will be randomised in September 2013 to receive active treatment (Grazax®) or placebo during 2 years. Placebo group will be treated 2 years with placebo and a third year with active therapy (Grazax®) and active group will continue the active treatment in the third year. In the last year, all placebo patients will be changed to active group and active and placebo patients will be informed about, but the trial will not be unblinded until the end of the third year and patients won´t know what treatment they were assigned to during the first 2 years.

Conditions

Allergic Rhinitis Due to Grass Pollens

Keywords

Allergy; Phleum pratense; Rhinoconjunctivitis; asthma; positive SPT to Phleum pratense

Outcome Measures

Primary Outcomes (1)

• Cellular populations (neutrophils, eosinophils, basophils, monocytes, DCs and lymphocytes populations)

  2 years

Secondary Outcomes (2)

• Global improvement on the Visual Analogue Scale

  2 years

• Number of participants with IMP related adverse events

  2 years

Study Arms (2)

GRAZAX

ACTIVE COMPARATOR

Tablet 75.000SQ-T once daily

Drug: Grazax

Placebo

PLACEBO COMPARATOR

Tablet with no active grass component

Other: Placebo

Interventions

Grazax DRUG

GRAZAX

GRAZAX

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• A history of grass pollen allergy
• Positive skin prick test to grass
• Positive specific IgE against Phl p 5
• Written informed consent before entering the trial.
• Female subjects who are fertile must have a negative pregnancy test and be willing to practise appropriate contraceptive methods.
• Subject willing and able to comply with the trial protocol.

You may not qualify if:

• Previous treatment by immunotherapy with grass allergen extracts.
• Ongoing treatment with any allergen specific immunotherapy product.
• Previous or ongoing treatment with Omalizumab, mono amine oxidase (MAO) inhibitors or tricyclic antidepressant medication.
• Use of medication at the screening visit which can interfere with SPT results
• A clinical history of symptomatic perennial allergic rhinitis or asthma.
• History of allergy, hypersensitivity or intolerance to the excipients of IMP (except for Phleum pratense).
• Systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease, or immune deficiency disease).
• Any clinically relevant chronic disease (≥ 3 months duration) (e.g. cystic fibrosis, malignancy, type I diabetes mellitus, malabsorption or malnutrition, renal or hepatic insufficiency).
• Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis at randomisation.
• FEV1 ≤ 70% of predicted value.
• Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomisation.
• Being immediate family of the investigator or trial staff.
• A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the trial, and/or evidence of an uncooperative attitude.
• Unlikely to be able to complete the trial, for any reason, or likely to move, or travel for extended periods of time during the trial period.
• Use of an investigational drug within 30 days or 5 half-lives, whichever is longest, prior to screening.

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Study Sites (2)

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Clínico Universitario San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Hypersensitivity; Asthma

Interventions

Grazax

Condition Hierarchy (Ancestors)

Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate

Study Officials

• CARLOS BLANCO, MD

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 15, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 28, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)