- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05641272
Clinical Trial to Evaluate the Efficacy and Safety of Polymerized, Mannan-Conjugated Dermatophagoides Allergen Extract (MM09-SLIM)
Prospective, Randomised, DBPC Clinical Trial to Evaluate the Efficacy and Safety of Polymerized and Mannan Conjugated Allergen Extract of Dermatophagoides for the Treatment of Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
Prospective, randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of polymerized and mannan conjugated allergen extract of Dermatophagoides for the treatment of allergic rhinitis/rhinoconjunctivitis with or without asthma.
The main objective of the clinical trial is to evaluate the clinical efficacy of the investigational medicinal product, administered sublingually, compared to placebo for the treatment of moderate-severe rhinitis/rhinoconjunctivitis with or without mild to moderate asthma and controlled using the Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (R-CSMS).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Allergen-specific immunotherapy (AIT) has been shown to be effective in relieving symptoms, reducing medication use, and improving quality of life in patients with respiratory allergies). This is thought to be due to the induction of a state of tolerance to specific allergens with long-lasting effects after discontinuation of treatment. And it is accepted that immunotherapy is the only available method for allergists to improve or cure, partially or definitely, an allergic process The study population of this clinical trial will comprise subjects allergic to mites (Dermatophagoides pteronyssinus and/or D. farinae) with symptoms of moderate-severe rhinitis/rhinoconjunctivitis with or without mild to severe controlled asthma, suitable to allergen immunotherapy.
The primary efficacy endpoint will be the combined rhinitis/rhinoconjunctivitis symptom and medication score.
Every single day from the beginning of the administration of the investigational drug (V2-VF), the subject will be asked to score and register his/her symptoms and record medication consumption in an electronic diary following the instructions of the application. This diary will provide the symptom score and medication consumption for each subject during the trial.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Miguel Casanovas, MD, PhD
- Phone Number: (+34) 691490175
- Email: mcasanovas@inmunotek.com
Study Locations
-
-
Paraguay
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Buenos Aires, Paraguay, Argentina, 2035
- Fundacion CIDEA
-
Contact:
- Jorge Fernando Maspero, MD
- Email: jorge.maspero@fundacioncidea.org.ar
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Principal Investigator:
- Jorge Fernando Máspero
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Signed Informed Consent Form.
- Male or female, aged between 12 and 60 years, both included.
- Confirmed clinical history of inhalation allergy with moderate-severe rhinitis/rhinoconjunctivitis according to the ARIA classification with or without controlled mild-moderate intermittent or persistent asthma according to the definition of GEMA 5.0 y GINA caused by allergy to mites (D. pteronyssinus and/or D. farinae). The asthma diagnostic will be valid up to 24 months prior to signing the informed consent form.
- Combined Symptom and Medication Score for moderate to severe rhinitis/rhinoconjunctivitis (RCSMS) ≥ 1,8 out of 3.
- Positive skin prick test (wheal major diameter ≥ 5 mm) to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The results will be valid up to 12 months prior to signing the informed consent form.
- Specific IgE against a complete extract of Dermatophagoides pteronyssinus and/or D. farinae or any the molecular components of allergenic sources with a value ≥ 3.5 kU/L. The results will be valid up to 12 months prior to signing the informed consent form.
Subjects shall preferably be monosensitised to the study allergens. In case of subjects sensitised to other aeroallergens, only those with the following characteristics may be included in the study (results will be valid up to 12 months prior to signing the informed consent form):
- Subjects with a positive skin prick test to Blomia tropicalis and Lepidoglyphus destructor, whose wheal major diameter and specific IgE values do not exceed or equal the values for the study allergens.
- Subjects with a positive skin prick test for dander if they have occasional exposure and symptoms.
- Subjects with positive skin prick test to pollens, whose specific IgE values do not exceed or equal the values for the study allergens and who also do not have exacerbations during pollen season. The maximum specific IgE value to theses allergens is 17.5 kU/L.
- Subjects with negative skin prick test to mold. In case specific IgE determination have been performed, the result must be <0.35 kU/L.
- Women of childbearing age (since menarche) must present a negative urine pregnancy test at the time of trial enrollment.
- Women of childbearing age must commit to using and adequate contraception method.
- Subjects capable of complying with a dosage regimen.
- Subjects owning a smartphone to register symptoms and medication consumption.
Exclusion Criteria:
- Subjects polysensitized to other aeroallergens with clinically relevant symptoms.
- Subjects who have received previous immunotherapy in the preceding 5 years to any of the tested allergens or a cross-reactive allergen or are currently receiving immunotherapy with any allergen.
- Patients in whom immunotherapy may be subject to an absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee may not be included.
- Subjects with uncontrolled severe asthma, and/or with FEV1 <80% of baseline despite adequate pharmacological treatment by the time of the enrolment.
- Subjects on treatment with ß-blockers.
- Subjects on treatment with immunosuppressive or biological drugs.
- Subjects who are unstable by the time of enrolment (respiratory infection, febrile process, acute pruritus, etc.).
- Subjects with chronic urticaria during the last 2 years, severe anaphylaxis or with hereditary angioedema history.
- Subjects with any pathology in which the administration of adrenaline is contraindicating (hyperthyroidism, hypertension, heart disease, etc.) according to the investigator discretion.
- Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but potentially serious and that could interfere with treatment and follow-up (epilepsy, psychomotor disorders, diabetes, malformations, multi-surgery, nephropathy, etc.), according to the investigator discretion.
- Subjects with severe autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or diagnosed with immunodeficiencies.
- Subject whose condition prevents him/her from offering cooperation and/or who presents severe psychiatric disorders, according to the investigator discretion.
- Subjects with known allergy to the other components of the investigational product other than allergen study.
- Subjects with lower airway diseases other than asthma such as emphysema or bronchiectasis.
- Pregnant or breastfeeding women.
- Subjects who are immediate family members of researchers.
- Concurrent participation in other clinical trials or previous participation within 30 days prior to inclusion.
- History of severe systemic reactions, including food, hymenoptera venom, etc.
- Subjects who have suffered a respiratory tract infection and/or asthma exacerbation within 4 weeks prior to screening.
- Subjects with a history of significant renal disease or chronic liver disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group I: sublingual allergoid-mannan conjugates (MM09 at 3.000 UTm/mL)
Allergoid (Dermatophagoides pteronyssinus and Dermatophagoides farinae)-mannan conjugates (MM09) at 3.000 UTm/mL for sublingual immunotherapy.
The dose is 2 sprays daily applied to the sublingual mucosa for 6 months.
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Allergoid (Dermatophagoides pteronyssinus and Dermatophagoides farinae)-mannan conjugates (MM09) at 3.000 UTm/mL for sublingual immunotherapy.
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Experimental: Group II: sublingual allergoid-mannan conjugates (MM09 at 9.000 UTm/mL)
Allergoid (Dermatophagoides pteronyssinus and Dermatophagoides farinae)-mannan conjugates (MM09) at 9.000 UTm/mL for sublingual immunotherapy..
The dose is 2 sprays daily applied to the sublingual mucosa for 6 months.
|
Allergoid (Dermatophagoides pteronyssinus and Dermatophagoides farinae)-mannan conjugates (MM09) at 9.000 UTm/mL for sublingual immunotherapy.
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Placebo Comparator: Group III: sublingual placebo
The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.The dose is 2 sprays daily applied to the sublingual mucosa for 6 months.
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The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rhinitis/rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS)
Time Frame: 6 months
|
Assessment of the number of rhinitis/rhinoconjunctivitis symptoms and medication consumption required to control these symptoms for each subject during the trial, for each group compared to the others, and compared to placebo. Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score will be based on the work done by Pfaar et al. The score for each rhinitis/rhinoconjunctivitis symptom will be 0 = No symptoms; 1 = Mild; 2 = Moderate; 3 = Severe. Total daily symptom score = 0-3 The score for Rhinitis/rhinoconjunctivitis medication will be: 0 = No medication; 1 = Oral or topical (eye or nose) non-sedating 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 |
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rhinitis/ Rhinoconjunctivitis Symptom Score (RSS)
Time Frame: 6 months
|
Assessment of the number of rhinitis/rhinoconjunctivitis symptoms for each subject during the trial, for each group compared to the others, and compared to placebo. The score for each rhinitis/rhinoconjunctivitis symptom will be 0 = No symptoms; 1 = Mild; 2 = Moderate; 3 = Severe. Total daily symptom score = 0-3 |
6 months
|
Rhinitis/Rhinoconjunctivitis Medication Score (RMS)
Time Frame: 6 months
|
Evaluation of the medication consumption required to control the rhinitis/rhinoconjunctivitis symptoms for each subject during the trial, for each group compared to the others, and compared to placebo. The score for rhinitis/rhinoconjunctivitis medication will be: 0 = No medication; 1 = Oral or topical (eye or nose) non-sedating 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 |
6 months
|
Asthma Combined Symptom and Medication Score (ACSMS)
Time Frame: 6 months
|
Evaluation of the number of asthma symptoms and medication consumption required to control these symptoms for each subject during the trial, for each group compared to the others, and compared to placebo. The score for each asthma symptom will be: 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 the drugs are included in the Guía Española para el Manejo del Asma (GEMA) 5.0 and Global Initiative for Asthma (GINA) 2020 guidelines. The scoring method is detailed in the article entitled "Combination of Allergic Asthma Symptom and Medication Scores in Allergen Immunotherapy Trials: A Proposal". Total daily medication score (ACSMS) = 0-3 |
6 months
|
Asthma Symptom Score (ASS)
Time Frame: 6 months
|
Assessment of the number of asthma symptoms of each subject during the trial, for each group compared to the others, and compared to placebo. The score for each asthma symptom will be: 0 = No symptoms; 1 = Mild; 2 = Moderate; 3 = Severe. Total daily symptom score (ASS) = 0-3 |
6 months
|
Asthma Medication Score (AMS)
Time Frame: 6 months
|
Evaluation of the medication consumption required to control the asthma symptoms for each subject during the trial, for each group compared to the others, and compared to placebo. The medication will be scored based on the therapeutic step in which the drugs are included in the GEMA 5.0 and GINA 2020 guidelines. Total daily medication score (AMS) = 0-3 |
6 months
|
Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score (ARSS)
Time Frame: 6 months
|
Evaluation of the number of asthma and rhinitis/rhinoconjunctivitis symptoms of each subject during the trial, for each group compared to the others, and compared to placebo. The score for each and asthma rhinitis/rhinoconjunctivitis symptom will be 0 = No symptoms; 1 = Mild; 2 = Moderate; 3 = Severe. Total daily symptom score = 0-3 |
6 months
|
Asthma and Rhinitis/Rhinoconjunctivitis Medication Score (ARMS)
Time Frame: 6 months
|
Assessment of the number of medication consumption required to control asthma and rhinitis/rhinoconjunctivitis symptoms for each subject during the trial, for each group compared to the others, and compared to placebo. The score for rhinitis/rhinoconjunctivitis medication will be: 0 = No medication; 1 = Oral or topical (eye or nose) non-sedating H1 antihistamines (H1A); 2 = Intranasal corticosteroids (INS) with/without H1A; 3 = Oral corticosteroids with/without (INS), with/without H1A. The asthma medication will be scored based on the therapeutic step in which the drugs are included in the GEMA 5.0 and GINA 2020 guidelines. Total daily medication score (ARMS) = 0-3 |
6 months
|
Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (ARCSMS)
Time Frame: 6 months
|
Evaluation of the number of asthma and rhinitis/rhinoconjunctivitis symptoms and medication consumption required to control these symptoms for each subject during the trial, for each group compared to the others, and compared to placebo. The score 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 score for rhinitis/rhinoconjunctivitis medication consumption will be: 0 = No medication; 1 = Oral or topical (eye or nose) non-sedating H1 antihistamines (H1A); 2 = Intranasal corticosteroids (INS) with/without H1A; 3 = Oral corticosteroids with/without (INS), with/without H1A. The score for the asthma medication will be based on the therapeutic step in which drugs are included in the GEMA 5 guide. Total daily medication score = 0-3 |
6 months
|
Symptom free-days (rhinitis/rhinoconjunctivitis, asthma)
Time Frame: 6 months
|
Number of days that the subjects have no symptom
|
6 months
|
Medication free days (rhinitis/rhinoconjunctivitis, asthma)
Time Frame: 6 months
|
Number of days that the subjects need no medication
|
6 months
|
Asthma exacerbations
Time Frame: 4 months
|
Time elapsed to first asthma exacerbation, number, duration and severity.
|
4 months
|
Clinical benefit
Time Frame: 6 months
|
Elapsed time to clinical benefit
|
6 months
|
Respiratory function
Time Frame: 6 months
|
Forced expiratory volume at one second (FEV1) and peak expiratory flow (PEF) will be measured to assess the degree of airflow obstruction. International consensus guidelines suggest that in asthma the measurements of FEV1 and PEF are equivalent when expressed as the per cent of predicted values. FEV1 of 80 to 100 percent is generally considered normal. FEV1 between 60 and 79 percent of predicted indicates a mild obstruction FEV1 between 40 and 59 percent indicates a moderate obstruction |
6 months
|
Number of eosinophil
Time Frame: 6 months
|
A blood sampling will be performed determine the number of eosinophils.
|
6 months
|
Immunological parameters in blood
Time Frame: 6 months
|
A blood sampling will be performed determine
|
6 months
|
Immunological parameters in nasal mucosa.
Time Frame: Month 2 and month 7
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A nasal sample will be taken using nasal swabs to determine the following immunological parameters:
|
Month 2 and month 7
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Asthma Quality of Life Questionnaire (AQLQ)
Time Frame: Month 2 and month 7
|
Asthma Quality of Life Questionnaire (AQLQ) consists of 32 items and 4 domains (symptoms, activity limitations, emotional function and environmental stimuli).
Each item is scored from 1 ("no impairment") to 7 ("severe impairment")
|
Month 2 and month 7
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Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Time Frame: 6 months
|
The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) consists of 28 items (questions) and 7 domains (Activities, Sleep, General symptoms, Practical problems, Nose symptoms, Eye symptoms and Emotional). The score of each item for all domains, except for the emotional domain, ranges from 0 ("It did not bother me at all") to 6 ("It bothered me a lot"). The score for the emotional domain ranges from 0 ("Never") to 6 ("Always"). |
6 months
|
Asthma Control Questionnaire (ACQ 6)
Time Frame: 4 months
|
The Asthma Control Questionnaire (ACQ-6) consists of 6 questions. In questions 1-6, subjects recall their experience over the past 7 days and respond using a 7-point scale from 0 ("totally controlled") to 6 ("extremely poorly controlled"). The score of the questionnaire is the mean of the 6 answers (i.e., the sum of the 6 answers divided by 6). The interpretation of the scores is as follows:
|
4 months
|
Asthma Control Questionnaire (ACQ 7)
Time Frame: 6 months
|
The ACQ questionnaire consists of 7 questions (ACQ-7) 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) The interpretation of the scores is as follows:
|
6 months
|
Visual Analogue Scales (VAS)
Time Frame: 7 months
|
The visual analogue scale is a 10 cm straight line, where the left end means that the subject feels very bad, and the right end means that the subject feels very well. Throughout the trial, two VAS scale measurements will be used:
|
7 months
|
Consumption of health resources
Time Frame: 7 months
|
For each subject, the number of times that due to allergy symptoms has done the following will be counted:
|
7 months
|
Security parameters
Time Frame: Month 2 and month 7
|
Global rate and severity of Adverse Events (AE) per administration and per subject
|
Month 2 and month 7
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Number of Local Adverse Reactions
Time Frame: 6 months
|
Local adverse reactions are those that appear at the site of the administration.
They are classified into: Immediate (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)
|
6 months
|
Number of Systemic Adverse Reactions
Time Frame: 6 months
|
Systemic adverse reactions are those that appear in other parts of the body other than the site of administration. Their severity will be classified according to World Allergy Organization, measured according to the following grades:
|
6 months
|
Number of Adverse Reactions to any medication
Time Frame: 7 months
|
Number of Adverse Reactions to any medication administered for the treatment of AE/AR
|
7 months
|
Treatment adherence
Time Frame: 6 months
|
At each visit, a new bottle shall be provided to the subject and the previous bottle shall be collected.
The amount remaining in each returned bottle shall be analysed to assess adherence to treatment.
|
6 months
|
Compliance of the electronic diary
Time Frame: 6 months
|
All subjects included in the trial will download the "ITK Diary Card" app on their mobile phone, which will be used as the subject's electronic diary. Subjects will fill in their symptoms and medication intake. At each visit, the investigator should review the subject's electronic diary to ensure compliance. For the calculation of the main variable, only those subjects that have reported data corresponding to at least 40% of the days will be considered. Therefore, for subjects with less than 40% of the reported data, the main variable cannot be calculated. |
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jorge Fernando Maspero, MD, PhD, Fundacion CIDEA
Publications and helpful links
General Publications
- Sirvent S, Soria I, Cirauqui C, Cases B, Manzano AI, Diez-Rivero CM, Reche PA, Lopez-Relano J, Martinez-Naves E, Canada FJ, Jimenez-Barbero J, Subiza J, Casanovas M, Fernandez-Caldas E, Subiza JL, Palomares O. Novel vaccines targeting dendritic cells by coupling allergoids to nonoxidized mannan enhance allergen uptake and induce functional regulatory T cells through programmed death ligand 1. J Allergy Clin Immunol. 2016 Aug;138(2):558-567.e11. doi: 10.1016/j.jaci.2016.02.029. Epub 2016 Apr 13.
- Soria I, Alvarez J, Manzano AI, Lopez-Relano J, Cases B, Mas-Fontao A, Canada FJ, Fernandez-Caldas E, Casanovas M, Jimenez-Barbero J, Palomares O, Vinals-Florez LM, Subiza JL. Mite allergoids coupled to nonoxidized mannan from Saccharomyces cerevisae efficiently target canine dendritic cells for novel allergy immunotherapy in veterinary medicine. Vet Immunol Immunopathol. 2017 Aug;190:65-72. doi: 10.1016/j.vetimm.2017.07.004. Epub 2017 Jul 23.
- Nieto A, Mazon A, Nieto M, Ibanez E, Jang DT, Calaforra S, Alba P, Perez-Frances C, Llusar R, Montoro J, de Mateo A, Alamar R, El-Qutob D, Fernandez J, Moral L, Toral T, Anton M, Andreu C, Ferrer A, Flores IM, Cerda N, Del Pozo S, Caballero R, Subiza JL, Casanovas M. First-in-human phase 2 trial with mite allergoids coupled to mannan in subcutaneous and sublingual immunotherapy. Allergy. 2022 Oct;77(10):3096-3107. doi: 10.1111/all.15374. Epub 2022 May 27.
- Caballero R, Grau A, Javaloyes G, Del Pozo S, Leon MA, Romero M, Casanovas M. Combination of Allergic Asthma Symptom and Medication Scores in Allergen Immunotherapy Trials: A Proposal. Int Arch Allergy Immunol. 2021;182(7):571-573. doi: 10.1159/000513543. Epub 2021 Jan 26. No abstract available.
- Passalacqua G, Baena-Cagnani CE, Bousquet J, Canonica GW, Casale TB, Cox L, Durham SR, Larenas-Linnemann D, Ledford D, Pawankar R, Potter P, Rosario N, Wallace D, Lockey RF. Grading local side effects of sublingual immunotherapy for respiratory allergy: speaking the same language. J Allergy Clin Immunol. 2013 Jul;132(1):93-8. doi: 10.1016/j.jaci.2013.03.039. Epub 2013 May 15.
- Malling HJ. The position of immunotherapy in the European Academy of Allergology and Clinical Immunology. J Investig Allergol Clin Immunol. 1997 Sep-Oct;7(5):356-7. No abstract available.
- Pfaar O, Klimek L, Gerth van Wijk R. Clinically relevant outcome measures for new pharmacotherapy, allergen avoidance and immunotherapy trials in allergic rhinoconjunctivitis. Curr Opin Allergy Clin Immunol. 2015 Jun;15(3):197-203. doi: 10.1097/ACI.0000000000000164.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Eye Diseases
- Bronchial Diseases
- Otorhinolaryngologic Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Conjunctival Diseases
- Rhinitis, Allergic, Perennial
- Asthma
- Rhinitis
- Rhinitis, Allergic
- Conjunctivitis
- Dust Mite Allergy
Other Study ID Numbers
- MM09-SLG-056
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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