A Phase 3 interventional study of MM09-MG01(30.000-30.000) and MG01(30.000) in Allergic Rhinoconjunctivitis, Perennial Allergic Rhinitis and House Dust Mite Allergy, sponsored by Inmunotek S.L.. Terminated at 13 sites in Spain. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-12-19.
Sponsored by Inmunotek S.L. · Phase 3, Interventional, and Treatment
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
Double blind, parallel placebo-controlled study. The subjects will receive medication during 11 months
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 18 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Inmunotek S.L. is the lead sponsor of 23 studies on the registry; 11 are open to participants now.
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Subjects will preferably be sensitive to study allergens (Dermatophagoides and grasses). In the case of subjects sensitized to other aeroallergens, only those with the following characteristics (results valid up to 12 months prior to signing of the informed consent) can be included in the study:
Exclusion Criteria:
30,000 AU/mL of MM09 and 30,000 AU/mL of MG01 of subcutaneous immunotherapy once a month for 11 months
Biological: MM09-MG01(30.000-30.000)
30,000 AU/mL of MG01 of subcutaneous immunotherapy once a month for 11 months
Biological: MG01(30.000)
30,000 AU/mL of MM09 of subcutaneous immunotherapy once a month for 11 months
Biological: MM09(30.000)
The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
Biological: Placebo subcutaneous
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
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
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
The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
CSMS: Combined Symptoms and Medication Score
Evaluation of the number of symptoms and the consumption of medication necessary for the control of such symptoms in asthma and rhinitis / rhinoconjunctivitis of each subject during the trial, of the groups with each other and with respect to placebo. - The endpoint for each asthma and rhinitis / rhinoconjunctivitis symptom will be as follows: 0 = No symptoms; 1 = Mild; 2 = Moderate; 3 = Severe Total daily symptom score = 0-3 * The asthma medication will be scored based on the therapeutic step in which drugs are included in the GEMA 5 guide. * The rhinitis / rhinoconjunctivitis medication score: 0 = No medication; 1 = oral or topical (eyes or nose) non-sedative H1 antihistamines (H1A); 2 = intranasal corticosteroids (INS) with / without H1A; 3 = oral corticosteroids with/without (INS), with/without H1A Total daily medication score = 0-3
Time frame: 12 months
Medication-free days
Number of days that the subjects need no medication
Time frame: 12 months
Symptom-free days
Number of days that the subjects have no symptom
Time frame: 12 months
Respiratory function_FEV1
Measurement of Forced Expiratory Volume in 1 Second (FEV1) %
Time frame: 12 months
Respiratory function_PEF
Peak Expiratory Flow (PEF) \[velocity\]
Time frame: 12 months
Asthmatic exacerbations
Time elapsed until the first appearance of asthmatic exacerbations, number, duration and severity.
Time frame: 12 months
Immunological parameters
Analyses of total and specific IgE, specific IgE index / total IgE and specific IgG4
Time frame: 12 months
Visual Analogue Scale (VAS)
Visual Analogue Scale in which the subject has to indicate in a straight line of 10cm how he/she feels regarding to his allergy symptoms. Being left side (0) = very bad and right side (10) = very well
Time frame: 12 months
Quality of life associated with rhinitis
The quality of life associated with rhinitis will be measured following the test ESPRINT-15. The scoring of the questionnaire will be carried out as follows: The global sum of the scores (ranging from "0 = nothing has bothered me" to "6 = it has bothered me a lot") of the 14 items plus the score given in the general questionnaire (ranging from "0 = Excellent" to "4 = Bad"). This sum is divided by the total number of items (15 items). The interpretation of the scores is between 0 (low impact) and 6 (high impact).
Time frame: 12 months
Quality of life associated with asthma
The quality of life associated with asthma will be measured following the ACQ questionnaire. The ACQ questionnaire consists of 7 questions (ACQ-7) or 6 questions (ACQ-6). In questions 1-6, patients recall their experience during the last 7 days and answer using a scale of 7 points (from 0 = fully controlled to 6 = extremely poorly controlled). The seventh question, which refers to the% FEV1 of the reference value, must be completed by an employee of the site. The questionnaire score is the mean of the 7 responses (ACQ-7) or 6 responses (ACQ-6). The interpretation of the scores is as follows: * Less than or equal to 0.75: Adequate control of asthma * From 0.75 to 1.50: Partially controlled asthma * More than 1.50: Inadequate asthma control
Time frame: 12 months
Consumption of health resources
For each patient, the number of times that due to allergy symptoms has done the following will be counted: * have visited the family doctor * have made an unscheduled visit to the specialist * has gone to the emergency room * has been hospitalized * have needed to contact the doctor by phone
Time frame: 12 months
Security parameters
Global rate and severity of AE per administration and per subject
Time frame: 12 months
Number of Local Adverse Reactions
Local adverse reactions are those that appear at the site of the administration. They are classified into: Inmediate (it appears during the first 30 minutes from the administration of investigational product) and Late (it appears after the first 30 minutes from the administration of investigational product) Local adverse reactions are considered if a papule \> 5 cm in diameter occurs in the first 30 minutes after administration (immediate local reactions) or \> 10 cm if it is later (late local reactions).
Time frame: 12 months
Number of Systemic Adverse Reactions
Systemic adverse reactions are those that appear in other parts of the body other than the site of administration.Their severity will be classified following the indications proposed by the World Allergy Organization (WAO) in 2010, measured according to the following grades: * Grade 0: Absence of symptoms or nonspecific symptoms. * Grade 1: Signs or symptoms present in a system / organ (cutaneous, Upper respiratory tract, Conjunctival or Other) * Grade 2: Signs and symptoms of 2 or more organs / systems listed in Grade 1, or; Lower airway disease, or; Gastrointestinal symptoms, or; Other * Grade 3: Lower airway disease, or; Upper airway involvement * Grade 4: Lower or upper airway condition, or; Cardiovascular system involvement * Grade 5: Death
Time frame: 12 months
Number of Adverse Reactions to any medication
Number of Adverse Reactions to any medication administered for the treatment of AE
Time frame: 12 months
Plan to share: No
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Inmunotek S.L.