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

PHASE3TerminatedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

April 30, 2021

Primary Completion Date

October 9, 2023

Study Completion Date

October 9, 2023

Conditions
Allergic RhinoconjunctivitisPerennial Allergic RhinitisHouse Dust Mite AllergyPollen 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.

Trial Locations (13)

11008

Centro Médico ASISA Dr. Lobatón, Cadiz

13500

Hospital Santa Bárbara, Puertollano

15006

Hospital Universitario A Coruña, A Coruña

21003

C.P.E. Virgen de la Cinta - Hospital Universitario Juan Ramón Jiménez, Huelva

24404

Hospital el Bierzo, Ponferrada

27003

Hospital Universitario Lucus Augusti, Lugo

29004

Hospital Quirón Salud Málaga, Málaga

29010

Hospital Regional Universitario de Málaga, Málaga

31008

Hospital Universitario de Navarra, Pamplona

41009

Hospital Universitario Virgen Macarena, Seville

46010

Hospital Clínico Universitario de Valencia, Valencia

08907

Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat

01009

Hospital Universitario de Álava, Vitoria-Gasteiz

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

BioClever 2005 S.L.

OTHER

collaborator

NTS hub S.L

UNKNOWN

lead

Inmunotek S.L.

INDUSTRY

NCT04874714 - Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis | Biotech Hunter | Biotech Hunter