Dose-response Study With Subcutaneous Immunotherapy of an Standardized Dermatophagoides Pteronyssinus (DPT) Extract

Phase 2

Completed

• Conditions: Allergic Rhinoconjunctivitis
• Interventions: Biological: Allergovac depot

• Registration Number: NCT01564017
• Lead Sponsor: Roxall Medicina España S.A

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-26
• Study First Posted: 2012-03-27
• Study Start: 2012-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allergovac depot. Group 1	Allergovac depot	Increasing dosages till the maintenance dose of 0.0625 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Allergovac depot. Group 2	Allergovac depot	Increasing dosages till the maintenance dose of 0.125 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Allergovac depot. Group 3	Allergovac depot	Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Allergovac depot. Group 5	Allergovac depot	Increasing dosages till the maintenance dose of 0.75 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Allergovac depot. Group 4	Allergovac depot	Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Allergovac depot placebo. Group 6	Allergovac depot	The same scheme of treatment as the active groups

Primary Outcome Measures

Name	Time	Method
Changes in nasal provocation test	from baseline (V0) to final visit (VF 18 weeks after randmization)	Variation of the concentration of DPT extract needed to produce a positive nasal provocation test from baseline (V0) to final visit (FV). The changes will be compared among groups (including the placebo group).

Trial Locations

Locations (12)

Hospital Vega Baja; 🇪🇸 Orihuela, Alicante, Spain

Hospital Germans Triasl i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Blanca Paloma; 🇪🇸 Huelva, Spain

Hospital Universitari i Politècnic La Fe; 🇪🇸 Valencia, Spain

Hospital de Manises; 🇪🇸 Manises, Valencia, Spain

Hospital Marqués de Valdecilla; 🇪🇸 Santander, Spain

Hospital Universitari de Bellvitge; 🇪🇸 Barcelona, Spain

Hospital Luis Alcañiz; 🇪🇸 Xátiva, Valencia, Spain

Hospital Donostia; 🇪🇸 Donostia-San Sebastián, Guipuzcoa, Spain

Hospital Virgen de la Arrixaca; 🇪🇸 El Palmar, Murcia, Spain

Complejo Hospitalario Universitario de Santiago; 🇪🇸 Santiago de Compostela, La Coruña, Spain

Hospital Xeral de Vigo; 🇪🇸 Vigo, Pontevedra, Spain