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

Allergic Rhinoconjunctivitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564017
• Other study ID #: BIA--DPT-P2-001
• Secondary ID: 2011-004583-30
• Status: Completed
• Phase: Phase 2
• First received: March 23, 2012
• Last updated: April 28, 2017
• Start date: May 2012
• Est. completion date: May 2013

Study information

• Verified date: April 2017
• Source: Roxall Medicina España S.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Biological:
• Allergovac depot
Depot sterile suspension fpor subcutaneous injection Increasing concentrations to reach the following maintenance doses: Group 1: 0.25 SPT
• Allergovac depot
Depot sterile suspension for subcutaneous injection. Increasing concentrations to reach the following maintenance doses: Group 2: 0.5 SPT
• Allergovac depot
Depot sterile suspension for subcutaneous injection. Increasing concentrations to reach the following maintenance doses: Group 3: 1 SPT
• Allergovac depot
depot sterile suspension for subcutaneous injection Increasing concentrations to reach the following maintenance doses: Group 4: 2 SPT
• Allergovac depot
Depot sterile suspension for subcutaneous injection. Increasing concentrations to reach the following maintenance doses: Group 5: 4 SPT
• Allergovac depot
Sterile suspension for subcutaneous injection. Same number of administration as the active groups

Locations

Country	Name	City	State
Spain	Hospital Germans Triasl i Pujol	Badalona	Barcelona
Spain	Hospital Universitari de Bellvitge	Barcelona
Spain	Hospital Donostia	Donostia-San Sebastián	Guipuzcoa
Spain	Hospital Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital Blanca Paloma	Huelva
Spain	Hospital de Manises	Manises	Valencia
Spain	Hospital Vega Baja	Orihuela	Alicante
Spain	Hospital Marqués de Valdecilla	Santander
Spain	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela	La Coruña
Spain	Hospital Universitari i Politècnic La Fe	Valencia
Spain	Hospital Xeral de Vigo	Vigo	Pontevedra
Spain	Hospital Luis Alcañiz	Xátiva	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Roxall Medicina España S.A

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in nasal provocation test	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).	from baseline (V0) to final visit (VF 18 weeks after randmization)