<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01702103</url>
  </required_header>
  <id_info>
    <org_study_id>PHT-01-12</org_study_id>
    <nct_id>NCT01702103</nct_id>
  </id_info>
  <brief_title>Demonstrate the Therapeutic Clinical Equivalence of Two Mometasone Nasal Sprays</brief_title>
  <acronym>PHT-01-12</acronym>
  <official_title>MULTICENTER, RANDOMIZED, DOUBLE BLIND, CONTROLLED, CLINICAL STUDY TO DEMONSTRATE THE THERAPEUTIC CLINICAL EQUIVALENCE OF TWO MOMETASONE NASAL SPRAYS IN THE RELIEF OF THE SIGNS AND SYMPTOMS OF PERENNIAL ALLERGIC RHINITIS.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PH&amp;T S.p.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PH&amp;T S.p.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Demonstrate the therapeutic clinical equivalence of two mometasone nasal sprays in the relief&#xD;
      of the signs and symptoms of perennial allergic rhinitis, in term of changes at week 8 from&#xD;
      baseline of Total Nasal Symptom Scores (TNSS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Perennial allergic rhinitis may be defined clinically as an inflammatory condition of the&#xD;
      nose characterised by nasal obstruction, sneezing, itching, or rhinorrhoea. It occurs due to&#xD;
      an exaggerated response to an environmental trigger which results in inflammation of the&#xD;
      lining of the nose; it is similar to hayfever, however, the substances which cause the&#xD;
      allergic reaction are present all year round; common causes include the faecal matter of the&#xD;
      house dust-mite (Dermatophagoides pteronyssinus), animal proteins from domestic pets (saliva&#xD;
      or skin proteins), and industrial dusts and fumes In those with perennial rhinitis, cigarette&#xD;
      smoke, washing powders, detergents, strong perfume, and traffic fumes may exacerbate the&#xD;
      condition.&#xD;
&#xD;
      According with WAO (World Allergy Organization), perennial rhinitis predominates in South&#xD;
      America, Asia, Africa and Australia; perennial and seasonal rhinitis occur commonly in the&#xD;
      U.S.A. and Japan. Seasonal rhinitis predominates in Europe. In one study in London of adults&#xD;
      between the ages of 16 and 65 years, in 1991 the prevalence of rhinitis was 16%; of these, 8%&#xD;
      had perennial symptoms, 6% perennial and seasonal symptoms, and 2% seasonal symptoms alone.&#xD;
      As with asthma, both seasonal and perennial rhinitis seem to be increasing. The 2004-05&#xD;
      National Health Survey stated that 3.2 million Australians (approximately 16.1% of the&#xD;
      population) self-reported experiencing symptoms of hay-fever and perennial rhinitis. The&#xD;
      prevalence was found to be highest amongst those aged 25-34 and was slightly higher among&#xD;
      females (1.7 million) than males (1.5 million).&#xD;
&#xD;
      Perennial allergic rhinitis (PAR) as seasonal allergic rhinitis (SAR) result from an&#xD;
      immunological response mediated by IgE; there is also a Th2 cell component accounting for&#xD;
      chronic symptoms. Histamine is a well-known mediator responsible for the signs and symptoms&#xD;
      of SAR but many other mediators including leukotrienes and prostaglandin D2 are involved.&#xD;
&#xD;
      The management of perennial rhinitis involves the avoidance of triggers such as house&#xD;
      dust-mite faeces and animal proteins, in conjunction with pharmacological treatments as:&#xD;
&#xD;
      Corticosteroids as Budesonide, Mometasone furoate, in the form of a nasal spray are the&#xD;
      first-line treatment for perennial allergic rhinitis.&#xD;
&#xD;
      Antihistamines as Cetirizine hydrochloride, Fexofenadine hydrochloride, work by blocking the&#xD;
      effects of histamine which is one of the main substances driving allergic reactions.&#xD;
&#xD;
      Decongestants as Phenylephrine hydrochloride, may be taken orally or as a nasal spray to&#xD;
      reduce the secretions and swelling of the lining of the nose by constricting the blood&#xD;
      vessels in the nose. Anti-inflammatories as Sodium cromoglycate, block the inflammatory&#xD;
      pathways that cause the symptoms of perennial rhinitis, however, they have not been found to&#xD;
      be more effective than corticosteroids or antihistamines.&#xD;
&#xD;
      Eye drops as Ketotifen fumarate, Hydrocortisone acetate, may be used to control symptoms such&#xD;
      as itchy or watery eyes.&#xD;
&#xD;
      Allergen desensitisation involves exposing the patient to small doses of allergens in an&#xD;
      attempt to desensitize them and prevent an allergic response.&#xD;
&#xD;
      Corticosteroids, as reported above, in the form of a nasal spray are the first-line treatment&#xD;
      for perennial allergic rhinitis; one of the most widely used is mometasone furoate. A&#xD;
      meta-analysis of randomized, double blind, placebo controlled, clinical trials on mometasone&#xD;
      furoate nasal spray in the treatment of allergic rhinitis, by a comprehensive search of the&#xD;
      MEDLINE, LILACS, SCOPUS, and the Cochrane Library databases up to 31 October, 2007 was&#xD;
      carried out. Meta-analysis was performed with the random or the fixed effect models depending&#xD;
      on heterogeneity, by using revman 5 software on the sixteen of the 113 identified articles&#xD;
      that met the inclusion criteria. This meta-analysis provides a level Ia evidence for the&#xD;
      efficacy of MFSN in the treatment vs placebo, with adverse events frequency similar in both&#xD;
      groups.&#xD;
&#xD;
      On this basis we decided to design a trial to show therapeutic equivalence of a generic&#xD;
      mometasone product with the drug Nasonex® Nasal Spray which is already marketed.&#xD;
&#xD;
      Number of patients: 298 completed patients with Perennial Allergic Rhinitis are required in&#xD;
      this study; with a planned drop-out rate of 20%, 360 patients have to be enrolled.&#xD;
&#xD;
      Main Inclusion Criteria: Male and female, 12 years until 65 years old. Subjects with a&#xD;
      minimum of 2 years of previous history of perennial allergic rhinitis to at least one&#xD;
      perennial allergen at the time the study is being conducted.&#xD;
&#xD;
      Signed informed consent form. For patients under the age of majority the parent or legal&#xD;
      guardian should sign the consent form and the child will be required to sign a patient&#xD;
      &quot;assent&quot; form.&#xD;
&#xD;
      Subjects with perennial allergic rhinitis documented in writing positive allergic skin (a&#xD;
      wheal &gt;3mm) test or positive RAST test, performed at screening or within the past 12 months.&#xD;
&#xD;
      A score of at least 6 on the TNSS with a minimum score of at least 2 for &quot;nasal congestion&quot;&#xD;
      and a minimum score of at least 2 for one of the remaining 3 symptoms.&#xD;
&#xD;
      Subjects capable of recording nasal allergy diary every day. Main Exclusion Criteria: Females&#xD;
      who are pregnant, lactating or plan to get pregnant during the study.&#xD;
&#xD;
      History of asthma over the previous two years that required chronic therapy (with the&#xD;
      exception of occasional acute or mild exercise induced asthma).&#xD;
&#xD;
      Patients with some nasal conditions (i.e. infectious sinusitis, hypertrophic rhinitis), or&#xD;
      with clinically significant nasal deformity or any recent nasal surgery or trauma that has&#xD;
      not completely healed.&#xD;
&#xD;
      Upper respiratory tract infection or any untreated systemic infections within the previous 30&#xD;
      days.&#xD;
&#xD;
      Patients previously treated with mometasone within the previous 30 days Patients who have&#xD;
      received anti-allergy immunotherapy (desensitising subjects with increase of allergen&#xD;
      challenges) in the previous 2 years or are still receiving this kind of therapy.&#xD;
&#xD;
      Patients with a history of tuberculosis. Patients with glaucoma, cataracts, ocular herpes&#xD;
      simplex, conjunctivitis or other eye infection.&#xD;
&#xD;
      The patient has had recent exposure (30 days) or was at risk of being exposed to chicken pox&#xD;
      or measles.&#xD;
&#xD;
      Any known hypersensitivity to mometasone, other steroids or any of the components of the&#xD;
      study nasal spray.&#xD;
&#xD;
      Planned travel outside of the local area for more than 2 consecutive days or 3 days in total.&#xD;
&#xD;
      The patient has a history of alcohol or drug abuse.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">March 2013</completion_date>
  <primary_completion_date type="Anticipated">January 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>demonstrate the therapeutic clinical equivalence of two mometasone nasal sprays in the relief of the signs and symptoms of perennial allergic rhinitis, in term of changes at week 8 from baseline of Total Nasal Symptom Scores (TNSS).</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety monitoring AE, routine laboratory haematology, biochemical tests, urinalysis, assessment of adrenal function to be sure of lack of systemic effect of nasal spray formulation Overall Patient's and Physician's global assessment.</measure>
    <time_frame>8 weeks</time_frame>
    <description>Patients at week 8 with a 50% reduction in TNSS mean change from baseline. Symptom-free days. The mean change from baseline to week 8 for mean Total Non Nasal Symptom Scores (TNNSS).&#xD;
Use of rescue medication (Time Frame: 8 weeks). Individual patient-rated symptoms evaluation. Clinical Global Improvement (CGI) evaluation.&#xD;
Treatment compliance:&#xD;
That includes description of the patient's adherence to the optimal prolonged treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Nasal Obstruction</condition>
  <condition>Sneezing</condition>
  <condition>Itching</condition>
  <arm_group>
    <arm_group_label>Mometasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mometasone, nasal spray for 8 weeks, 2 actuations each nostril in the morning.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nasonex®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nasonex nasal spray for 8 weeks 2 actuations each nostril in the morning.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mometasone furoate</intervention_name>
    <arm_group_label>Mometasone</arm_group_label>
    <arm_group_label>Nasonex®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Male and female, 12 years until 65 years old. Subjects with a minimum of 2 years of&#xD;
        previous history of perennial allergic rhinitis to at least one perennial allergen at the&#xD;
        time the study is being conducted.&#xD;
&#xD;
        Signed informed consent form. For patients under the age of majority the parent or legal&#xD;
        guardian should sign the consent form and the child will be required to sign a patient&#xD;
        &quot;assent&quot; form.&#xD;
&#xD;
        Subjects with perennial allergic rhinitis documented in writing positive allergic skin (a&#xD;
        wheal &gt;3mm) test or positive RAST test, performed at screening or within the past 12&#xD;
        months.&#xD;
&#xD;
        A score of at least 6 on the TNSS with a minimum score of at least 2 for &quot;nasal congestion&quot;&#xD;
        and a minimum score of at least 2 for one of the remaining 3 symptoms.&#xD;
&#xD;
        Subjects capable of recording nasal allergy diary every day.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Females who are pregnant, lactating or plan to get pregnant during the study. History of&#xD;
        asthma over the previous two years that required chronic therapy (with the exception of&#xD;
        occasional acute or mild exercise induced asthma).&#xD;
&#xD;
        Patients with some nasal conditions (i.e. infectious sinusitis, hypertrophic rhinitis), or&#xD;
        with clinically significant nasal deformity or any recent nasal surgery or trauma that has&#xD;
        not completely healed.&#xD;
&#xD;
        Upper respiratory tract infection or any untreated systemic infections within the previous&#xD;
        30 days.&#xD;
&#xD;
        Patients previously treated with mometasone within the previous 30 days Patients who have&#xD;
        received anti-allergy immunotherapy (desensitising subjects with increase of allergen&#xD;
        challenges) in the previous 2 years or are still receiving this kind of therapy.&#xD;
&#xD;
        Patients with a history of tuberculosis. Patients with glaucoma, cataracts, ocular herpes&#xD;
        simplex, conjunctivitis or other eye infection.&#xD;
&#xD;
        The patient has had recent exposure (30 days) or was at risk of being exposed to chicken&#xD;
        pox or measles.&#xD;
&#xD;
        Any known hypersensitivity to mometasone, other steroids or any of the components of the&#xD;
        study nasal spray.&#xD;
&#xD;
        Planned travel outside of the local area for more than 2 consecutive days or 3 days in&#xD;
        total.&#xD;
&#xD;
        The patient has a history of alcohol or drug abuse.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alessandro Mazzetti, MD</last_name>
    <role>Study Director</role>
    <affiliation>Sintesi Research Srl</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Josè Eg Fabiani, Doctor</last_name>
    <phone>(00 54 11) 4983-1228</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Swiss Medical Group</name>
      <address>
        <city>Buenos Aires</city>
        <state>Capital Federal</state>
        <zip>C1118AAE</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <contact>
      <last_name>Carlos DEBASA, Dr.</last_name>
      <phone>0810-333-8876</phone>
    </contact>
    <investigator>
      <last_name>Carlos Debasa, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <reference>
    <citation>Sastre J, Mosges R. Local and systemic safety of intranasal corticosteroids. J Investig Allergol Clin Immunol. 2012;22(1):1-12.</citation>
    <PMID>22448448</PMID>
  </reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>October 4, 2012</last_update_submitted>
  <last_update_submitted_qc>October 4, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 5, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nasal Obstruction</mesh_term>
    <mesh_term>Sneezing</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mometasone Furoate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01702103
org study id: PHT-01-12
nct id: NCT01702103
lead sponsor: 
has dmc: No
Demonstrate the therapeutic clinical equivalence of two mometasone nasal sprays in the relief
      of the signs and symptoms of perennial allergic rhinitis, in term of changes at week 8 from
      baseline of Total Nasal Symptom Scores (TNSS).
Perennial allergic rhinitis may be defined clinically as an inflammatory condition of the
      nose characterised by nasal obstruction, sneezing, itching, or rhinorrhoea. It occurs due to
      an exaggerated response to an environmental trigger which results in inflammation of the
      lining of the nose; it is similar to hayfever, however, the substances which cause the
      allergic reaction are present all year round; common causes include the faecal matter of the
      house dust-mite (Dermatophagoides pteronyssinus), animal proteins from domestic pets (saliva
      or skin proteins), and industrial dusts and fumes In those with perennial rhinitis, cigarette
      smoke, washing powders, detergents, strong perfume, and traffic fumes may exacerbate the
      condition.

      According with WAO (World Allergy Organization), perennial rhinitis predominates in South
      America, Asia, Africa and Australia; perennial and seasonal rhinitis occur commonly in the
      U.S.A. and Japan. Seasonal rhinitis predominates in Europe. In one study in London of adults
      between the ages of 16 and 65 years, in 1991 the prevalence of rhinitis was 16%; of these, 8%
      had perennial symptoms, 6% perennial and seasonal symptoms, and 2% seasonal symptoms alone.
      As with asthma, both seasonal and perennial rhinitis seem to be increasing. The 2004-05
      National Health Survey stated that 3.2 million Australians (approximately 16.1% of the
      population) self-reported experiencing symptoms of hay-fever and perennial rhinitis. The
      prevalence was found to be highest amongst those aged 25-34 and was slightly higher among
      females (1.7 million) than males (1.5 million).

      Perennial allergic rhinitis (PAR) as seasonal allergic rhinitis (SAR) result from an
      immunological response mediated by IgE; there is also a Th2 cell component accounting for
      chronic symptoms. Histamine is a well-known mediator responsible for the signs and symptoms
      of SAR but many other mediators including leukotrienes and prostaglandin D2 are involved.

      The management of perennial rhinitis involves the avoidance of triggers such as house
      dust-mite faeces and animal proteins, in conjunction with pharmacological treatments as:

      Corticosteroids as Budesonide, Mometasone furoate, in the form of a nasal spray are the
      first-line treatment for perennial allergic rhinitis.

      Antihistamines as Cetirizine hydrochloride, Fexofenadine hydrochloride, work by blocking the
      effects of histamine which is one of the main substances driving allergic reactions.

      Decongestants as Phenylephrine hydrochloride, may be taken orally or as a nasal spray to
      reduce the secretions and swelling of the lining of the nose by constricting the blood
      vessels in the nose. Anti-inflammatories as Sodium cromoglycate, block the inflammatory
      pathways that cause the symptoms of perennial rhinitis, however, they have not been found to
      be more effective than corticosteroids or antihistamines.

      Eye drops as Ketotifen fumarate, Hydrocortisone acetate, may be used to control symptoms such
      as itchy or watery eyes.

      Allergen desensitisation involves exposing the patient to small doses of allergens in an
      attempt to desensitize them and prevent an allergic response.

      Corticosteroids, as reported above, in the form of a nasal spray are the first-line treatment
      for perennial allergic rhinitis; one of the most widely used is mometasone furoate. A
      meta-analysis of randomized, double blind, placebo controlled, clinical trials on mometasone
      furoate nasal spray in the treatment of allergic rhinitis, by a comprehensive search of the
      MEDLINE, LILACS, SCOPUS, and the Cochrane Library databases up to 31 October, 2007 was
      carried out. Meta-analysis was performed with the random or the fixed effect models depending
      on heterogeneity, by using revman 5 software on the sixteen of the 113 identified articles
      that met the inclusion criteria. This meta-analysis provides a level Ia evidence for the
      efficacy of MFSN in the treatment vs placebo, with adverse events frequency similar in both
      groups.

      On this basis we decided to design a trial to show therapeutic equivalence of a generic
      mometasone product with the drug Nasonex® Nasal Spray which is already marketed.

      Number of patients: 298 completed patients with Perennial Allergic Rhinitis are required in
      this study; with a planned drop-out rate of 20%, 360 patients have to be enrolled.

      Main Inclusion Criteria: Male and female, 12 years until 65 years old. Subjects with a
      minimum of 2 years of previous history of perennial allergic rhinitis to at least one
      perennial allergen at the time the study is being conducted.

      Signed informed consent form. For patients under the age of majority the parent or legal
      guardian should sign the consent form and the child will be required to sign a patient
      "assent" form.

      Subjects with perennial allergic rhinitis documented in writing positive allergic skin (a
      wheal >3mm) test or positive RAST test, performed at screening or within the past 12 months.

      A score of at least 6 on the TNSS with a minimum score of at least 2 for "nasal congestion"
      and a minimum score of at least 2 for one of the remaining 3 symptoms.

      Subjects capable of recording nasal allergy diary every day. Main Exclusion Criteria: Females
      who are pregnant, lactating or plan to get pregnant during the study.

      History of asthma over the previous two years that required chronic therapy (with the
      exception of occasional acute or mild exercise induced asthma).

      Patients with some nasal conditions (i.e. infectious sinusitis, hypertrophic rhinitis), or
      with clinically significant nasal deformity or any recent nasal surgery or trauma that has
      not completely healed.

      Upper respiratory tract infection or any untreated systemic infections within the previous 30
      days.

      Patients previously treated with mometasone within the previous 30 days Patients who have
      received anti-allergy immunotherapy (desensitising subjects with increase of allergen
      challenges) in the previous 2 years or are still receiving this kind of therapy.

      Patients with a history of tuberculosis. Patients with glaucoma, cataracts, ocular herpes
      simplex, conjunctivitis or other eye infection.

      The patient has had recent exposure (30 days) or was at risk of being exposed to chicken pox
      or measles.

      Any known hypersensitivity to mometasone, other steroids or any of the components of the
      study nasal spray.

      Planned travel outside of the local area for more than 2 consecutive days or 3 days in total.

      The patient has a history of alcohol or drug abuse.
allocation: Randomized
intervention model: Parallel Assignment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: demonstrate the therapeutic clinical equivalence of two mometasone nasal sprays in the relief of the signs and symptoms of perennial allergic rhinitis, in term of changes at week 8 from baseline of Total Nasal Symptom Scores (TNSS).
time frame: 8 weeks
measure: Safety monitoring AE, routine laboratory haematology, biochemical tests, urinalysis, assessment of adrenal function to be sure of lack of systemic effect of nasal spray formulation Overall Patient's and Physician's global assessment.
time frame: 8 weeks
description: Patients at week 8 with a 50% reduction in TNSS mean change from baseline. Symptom-free days. The mean change from baseline to week 8 for mean Total Non Nasal Symptom Scores (TNNSS).
Use of rescue medication (Time Frame: 8 weeks). Individual patient-rated symptoms evaluation. Clinical Global Improvement (CGI) evaluation.
Treatment compliance:
That includes description of the patient's adherence to the optimal prolonged treatment.
arm group label: Mometasone
arm group type: Experimental
description: Mometasone, nasal spray for 8 weeks, 2 actuations each nostril in the morning.
arm group label: Nasonex®
arm group type: Active Comparator
description: Nasonex nasal spray for 8 weeks 2 actuations each nostril in the morning.
intervention type: Drug
intervention name: Mometasone furoate
arm group label: Mometasone
arm group label: Nasonex®
criteria: 
gender: All
minimum age: 12 Years
maximum age: 65 Years
healthy volunteers: No
last name: Alessandro Mazzetti, MD
role: Study Director
affiliation: Sintesi Research Srl
last name: Josè Eg Fabiani, Doctor
phone: (00 54 11) 4983-1228
facility: 
contact: 
investigator: 
country: Argentina
citation: Sastre J, Mosges R. Local and systemic safety of intranasal corticosteroids. J Investig Allergol Clin Immunol. 2012;22(1):1-12.
PMID: 22448448
responsible party type: Sponsor
mesh term: Nasal Obstruction
mesh term: Sneezing
mesh term: Mometasone Furoate