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Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis

NCT04874714 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-12-19

No results posted yet for this study

Summary

Prospective, randomized, placebo-controlled, multicenter of 3 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with mild to moderate asthma and allergic rhinitis/rhinoconjunctivitis (intermittent or persistent) due to hypersensitivity to house dust mites (Dermatophagoides pteronyssinus and / or D. farinae) and grass pollen

Conditions

  • Allergic Rhinoconjunctivitis
  • Perennial Allergic Rhinitis
  • House Dust Mite Allergy
  • Pollen Allergy

Interventions

BIOLOGICAL

MM09-MG01(30.000-30.000)

Mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 30,000 AU / mL and grasses mixture (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca elatior, Lolium perenne and Dactylis glomerata) with a concentration of 30,000 AU / mL: Purified allergenic extract, adsorbed in aluminum hydroxide and polymerized with glutaraldehyde

BIOLOGICAL

MG01(30.000)

Grasses mixture (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca elatior, Lolium perenne and Dactylis glomerata) with a concentration of 30,000 AU / mL: Purified allergenic extract, adsorbed in aluminum hydroxide and polymerized with glutaraldehyde

BIOLOGICAL

MM09(30.000)

Mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 30,000 AU / mL: Purified allergenic extract, adsorbed in aluminum hydroxide and polymerized with glutaraldehyde

BIOLOGICAL

Placebo subcutaneous

The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.

Sponsors & Collaborators

  • BioClever 2005 S.L.

    collaborator OTHER

  • NTS hub S.L

    collaborator UNKNOWN

  • Inmunotek S.L.

    lead INDUSTRY

Principal Investigators

  • Ana Isabel Tabar Purroy, MD; PhD · Complejo Hospitalario de Navarra

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2023-10-09
Completion
2023-10-09

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04874714 on ClinicalTrials.gov