Clinical trial NCT01564017: Dose-response Study With Subcutaneous Immunotherapy of an Standardized Dermatophagoides Pteronyssinus (DPT) Extract
Official title: Phase II, Multicenter, Randomized, Double-blind Study, With Subcutaneous Immunotherapy, in Parallel Groups and Placebo-controlled, in Patients With Rhinoconjunctivitis ± Asthma Sensitized to Dermatophagoides Pteronyssinus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinoconjunctivitis
Keywords: Allergy
Allergic rhinoconjunctivitis
Immunotherapy
D. pteronyssinus
house dust allergy
Lead sponsor: Roxall Medicina España S.A
Sponsor class: INDUSTRY
First posted: 2012-03-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As part of the registration plan of our products and after performing a Phase I study the present trial has been designed to compare the efficacy of 5 different doses of subcutaneous immunotherapy in depot presentation.


Eligibility criteria: Inclusion Criteria:

1. Patients must sign the Informed Consent Form.
2. Patients must be between 18 and 60 years of age.
3. Patients with perennial allergic rhinoconjunctivitis produced by Dermatophagoides pteronyssinus during at least 2 years prior to participating in the study. Although the pathology being studied is allergic rhinoconjunctivitis, patients who have concomitant mild or moderate asthma may be included.
4. Patients who have had a skin prick test result greater or equal to 3 mm in diameter against Dermatophagoides pteronyssinus.
5. Patients who have specific Immunoglobulin E (IgE) greater or equal to class 2 (CAP/PHADIA) to Dermatophagoides pteronyssinus.
6. Patients will preferably be monosensitized to Dermatophagoides pteronyssinus. Polysensitized patients may only be included in the study if their other sensitizations are produced by:

   * Pollens whose season period does not overlap with the study treatment or, if overlap, whose specific IgE levels are less than class 2.
   * Perennial allergens with specific IgE levels less than class 2.
   * Allergens that do not cohabit with the patient or whose environmental levels are not high enough to produce symptoms during the study period.
7. Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.
8. Furthermore, women of child-bearing potential must agree to use adequate contraceptive methods during this study if they are sexually active.

Exclusion Criteria:

1. Patients with stable and continued use of medication to treat their allergic condition during the 2 weeks prior to their inclusion in the study.
2. Patients sensitized and with specific IgE levels greater or equal to class 2 to other perennial or seasonal allergens clinically relevant including other mites unless they are cross reactive with Dermatophagoides pteronyssinus.
3. Patients who have received immunotherapy in the 5 years prior to the study against either the allergen being tested or an allergen which is cross-reactive, or who are currently receiving immunotherapy for any other allergen.
4. Patients with severe asthma or FEV1\< 70% or with asthma which requires treatment with inhaled or systemic corticoids at the time of the study or in the 8 weeks immediately prior to the onset of treatment.
5. Patients with immunological, cardiac, renal or hepatic diseases or with any other illness which the investigators deem may interfere with the study.
6. Patients with a prior history of anaphylaxis.
7. Patients with chronic urticaria.
8. Patients with moderate-severe atopic dermatitis.
9. Patients with clinically relevant malformations of the upper respiratory tract.
10. Patients who have participated in another clinical trial within 3 months prior to this study.
11. Patients being treated with tricyclic antidepressants, psychotropic drugs, beta-blockers, or angiotensin-converting enzyme inhibitors (ACEIs).
12. Women who are pregnant or breast-feeding or are of child-bearing age and who do not agree to use adequate contraception if they are sexually active and who have not demonstrated that they have been surgically sterilized or have other means of not bearing children.
13. Patients who cannot attend study visits.
14. Patients who are uncooperative or refuse to participate in the study.

Primary outcomes:
measure: Changes in nasal provocation test
timeFrame: from baseline (V0) to final visit (VF 18 weeks after randmization)
Secondary outcomes:
Other outcomes:
Locations:
city: Orihuela
country: Spain
facility: Hospital Vega Baja
state: Alicante
city: Badalona
country: Spain
facility: Hospital Germans Triasl i Pujol
state: Barcelona
city: Donostia-San Sebastián
country: Spain
facility: Hospital Donostia
state: Guipuzcoa
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
state: La Coruña
city: El Palmar
country: Spain
facility: Hospital Virgen de la Arrixaca
state: Murcia
city: Vigo
country: Spain
facility: Hospital Xeral de Vigo
state: Pontevedra
city: Manises
country: Spain
facility: Hospital de Manises
state: Valencia
city: Xátiva
country: Spain
facility: Hospital Luis Alcañiz
state: Valencia
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Huelva
country: Spain
facility: Hospital Blanca Paloma
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
Study officials:
affiliation: Hospital Universitario Marqués de Valdecilla
name: Fernando Rodríguez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Marqués de Valdecilla
name: Ramón Lleonart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Germans Trias i Pujol Hospital
name: Albert Roger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario La Fe
name: Dolores Hernández, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Hospitalario Universitario de Santiago
name: Carmen Vidal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen de la Arrixaca
name: Juan A Pagán, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Xeral de Vigo
name: Carmen Marcos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Donostia
name: Jose A Navarro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Blanca Paloma
name: Victoria Moreno, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Luis Alcañiz
name: Luis A Navarro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Vega Baja
name: María I Peña, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Manises
name: Marta Alvariño, MD
role: PRINCIPAL_INVESTIGATOR
References: