Safety Clinical Trial With Depigopid 50% Grasses/50% Olea Europaea(2000DPP/ml) or Depigoid 50% Grasses/50% Parietaria Judaica(2000DPP/ml).

NCT01734265 | Completed Phase 2

• 2 other identifiers: 6078-PG-PSC-1932012-001699-12
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 4

Brief Summary

The primary objective of this study is to evaluate the safety and tolerance of a rush build up administration of Depigoid forte pollen and the first maintenance dose administered 4 weeks later.

Conditions

Allergy; Rhinitis; Rhinoconjunctivitis; Seasonal Asthma

Outcome Measures

Primary Outcomes (1)

• immediate or delayed systemic reaction of grade 2 or higher during the treatment period

  The primary variable in this study is the number of subjects \[%\] who experienced at least one immediate or delayed systemic reaction of grade 2 or higher during the treatment period.

  4 weeks

Secondary Outcomes (1)

• immediate and/or delayed systemic reactions and immediate and/or delayed local reactions

  4 weeks

Study Arms (2)

Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml)

EXPERIMENTAL

Depigoid 50%Grasses/ 50% Olea europaea (2.000 DPP/ml) The administration regimen will consist of a rush build-up regimen: 0.2 ml followed by 0.3 ml after 30 minutes if no adverse events occur a second maintenance dose of 0,5 ml 4 weeks later.

Drug: Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml)

Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml)

EXPERIMENTAL

Depigoid 50%Grasses/ 50% Parietaria judaica(2.000 DPP/ml) The administration regimen will consist of a rush build-up regimen: 0.2 ml followed by 0.3 ml after 30 minutes if no adverse events occur a second maintenance dose of 0,5 ml 4 weeks later.

Drug: Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml)

Interventions

Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml) DRUG

Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml)

Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml) DRUG

Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml)

Eligibility Criteria

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

You may qualify if:

• Subject has dated and signed the informed consent.
• Men and women between 18 and 60 years of age (both inclusive).
• Individuals suffering symptoms of allergic rhinoconjunctivitis or rhinitis during at least the preceding year, with or without allergic seasonal asthma caused by a clinically relevant sensitization to pollens (grasses AND P. judaica or O. europaea). Asthmatic patients can be included in the trial only if seasonal asthma is controlled with a medium daily dose minor or equal to 800 μg/day of budesonide or an equivalent or minor or equal to 400 μg/day of budesonide or an equivalent plus a long-acting- β2 agonist.
• Asthmatic patients must be stable within 3 months prior to Visit 1 and on an stable inhaled steroid dose within 6 weeks prior to visit 1 and throughout the study. FEV1 must be ≥ 80% of predicted value.
• The IgE-mediated sensitization must be demonstrated by the following:
• medical history AND IgE specific CAP RAST ≥ 2 to the suspected relevant pollens (grass pollen AND Olea and/or Parietaria) AND a positive skin prick test to grass and Olea and/or Parietaria.

You may not qualify if:

• Any contraindication for treatment with allergen specific immunotherapy.
• Forced expiratory volume in 1 s (FEV1) or peak expiratory flow (PEF) value \<80% of the predicted normal value.
• Clinically relevant allergy symptoms due to sensitization to perennial allergens (mites, molds, epithelia) or other seasonal pollen which might interfere with the safety of the IMP.
• Asthma requiring a dose \> 800 μg/day of Budesonide or an equivalent, without long-lasting beta-2 agonists or requiring a dose \> of 400 μg/day of Budesonide or an equivalent plus a long-acting-β2 agonist to reach asthma control, according to the Global Initiative for Asthma (GINA 2010)
• Patients with non controlled bronchial asthma within 3 months prior to Visit 1.
• Patients with asthma who have been treated with systemic steroids within 3 months prior to V1.
• Patients with hospital admission due to asthma exacerbations within 1 year prior to V1.
• Acute or chronic inflammatory or infectious diseases of the airways.
• Chronic structural diseases of the respiratory system (for example, emphysema or bronchiectasis).
• Immune system diseases, both autoimmune diseases and immunodeficiency.
• Any disease involving a contraindication for the use of adrenaline (for example, hyperthyroidism).
• Serious uncontrolled diseases involving a risk for the subjects participating in this study
• Malignant disease with activity in the last 5 years.
• Excessive consumption of alcohol, drugs or medication.
• Serious psychiatric, psychological or neurological disorders.

Sponsors & Collaborators

• Laboratorios Leti, S.L.: lead

Study Sites (4)

H. Manresa

Manresa, Barcelona, 08243, Spain

Location

H. Virgen Macarena

Seville, Sevilla, 41009, Spain

Location

H. Virgen del Rocío

Seville, Sevilla, 41013, Spain

Location

H. Luis Alcañiz

Xàtiva, Valencia, 46800, Spain

Location

MeSH Terms

Conditions

Hypersensitivity; Rhinitis

Condition Hierarchy (Ancestors)

Immune System Diseases; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Pedro Guardia, Dr

  H. Virgen Macarena

  PRINCIPAL INVESTIGATOR

• Joaquín Quiralte, Dr

  H. Virgen del Rocío

  PRINCIPAL INVESTIGATOR

• Luis Angel Navarro, Dr

  H. Luis Alcañiz

  PRINCIPAL INVESTIGATOR

• Santiago Nevot, Dr

  H. Manresa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2012
• First Posted: November 27, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 29, 2014

Record last verified: 2012-11

Locations

ES (4)