Clinical trial in several centers in which patients are administrating randomly in parallel with treatment or placebo (control). Neither the researchers nor the patients know which treatment the patiens are receiving. Present clinical trial evaluates safety and clinical efficacy of intradermal immunotherapy with polymerised Phleum pratense, in patients with allergic rhino-conjunctivitis with or without mild to moderate asthma, sensitized to Phleum pratense pollen.

Phase 1

• Conditions: Allergic patients to the pollen of Phleum pratense with allergic rhino-conjunctivitis with or without mild to moderate asthma.; MedDRA version: 16.1Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-000429-18-ES
• Lead Sponsor: DIATER, Laboratorio de Diagnóstico y Aplicaciones Terapéuticas, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-06
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

1. Age >=12 and <=50 years old
2. Patients that signed the informed consent to participate in the study
3. Allergic patients to Phleum pratense:
- Specific Ig E to Phleum pratense and or Phl p 1 >= 3.5 KU/L (CAP)
- Positive prick test to Phleum pratense, considering positive a wheal >= 3 mm with respect to the negative control
4. Patients with rinitis or rhinoconjunctivitis with or without mild to moderate ashtma in the last two years.
5. Patients able to fulfill the treatment
6. Women able to get pregnant should present a negative pregnancy test in the previous 7 days before the start of the trial, and use anticonceptive methods.
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 134
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with concomitant inmune diseases that could interfere with the clinical trial, as investigator discretion
2. Severe exacerbation of asthma that requires hospitalization, or FEV1<70%
3. Polisensitized patients to relevant allergens that could interfere with clinical trial.
4. Patients that received inmunotherapy against Gramineae in the last 5 years
5. Patients with uncontrolled moderate or severe ashtma
6. Malign diseases
7. Patients in which adrenaline administration is contraindicated.
8. Allergic patient to manitol.
9. Patients with active tuberculosis.
10. Patients with severe atopic eczema
11. Patients with dermographism or skin pathologies that could interfere with the assessment of prick test.
12. Psiquiatric alterations that unable the patient to fulfill with the treatment.
13. Patients treated with betablockers or IECA
14. Patients unable to fulfill the inmunotherapy treatment
15. Preagnant or breastfeeding women.
16. Fertile women that do not compromise to use anticonceptive methods.
17. Patients enrolled in other clinical trials
18. Patients of any disease that alter absorption or excretion of medicaments
19. Chronic alcohol or drugs consumption

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy assessment of Polymerized Phleum pratense inmunotherapy administed intradermally;Secondary Objective: - Efficacy assessment by a combined score of symptoms and medication<br>- Wheal and eritema at the site of administration measurement <br>- Ig E and Ig G levels<br>- Safety assessment;Primary end point(s): Assessment of efficacy of immunotherapy with polymerised Pheum pratense intradermally administered;Timepoint(s) of evaluation of this end point: At the end of the first pollen count season and at the end of the second one.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Assessment of efficacy endpoints other than combined score of symptoms and medicines. <br>Wheal and erythema measure after each treatment cycle . <br>Immunological endpoints (specific IgE and specific IgG4)<br>Assessment of safety of immunotherapy with polymerised Phleum pratense intradermally administered.;Timepoint(s) of evaluation of this end point: At the end of the first pollen count season and at the end of the second one.<br>After each treatment administration.