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A Study to Compare the Efficacy and Safety of Fluticasone Furoate Nasal Sprays (FFNS) 55 Microgram (mcg) and 110 mcg in Chinese Pediatric Subjects With Allergic Rhinitis (AR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02424539
Recruitment Status : Completed
First Posted : April 23, 2015
Results First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

This Phase IV interventional study is a multi-center, randomized, double-blind, placebo-controlled parallel study to evaluate the efficacy and safety of FFNS110 mcg and 55 mcg once daily versus vehicle placebo aqueous nasal spray in chinese pediatric subjects ages 2 to 12 years with AR.

This study comprises screening and run-in period (4 to14 days), double-blind treatment period (28 days) and follows up period (3 to7 days). Subjects entering the study will participate for maximum of 50 days, including five clinical visits and a follow-up contact.

The study is planned to enroll approximately 360 subjects.


Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Perennial and Seasonal Drug: FFNS Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Doubled-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of Fluticasone Furoate Nasal Spray 55 mcg and 110 mcg for 4 Weeks in Chinese Pediatric Subjects Ages 2 to 12 Years With Allergic Rhinitis
Actual Study Start Date : September 30, 2015
Actual Primary Completion Date : October 25, 2017
Actual Study Completion Date : October 25, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FFNS 55 mcg Arm
Each subject will be dispensed with two nasal spray device labelled as Device A and Device B containing either FF or Placebo. Subject's on their own or with assistance from parent/guardian will administer FFNS 55 mcg per day, one intranasal spray from Device A, once daily into each nostril (27.5 mcg per spray) and another spray of placebo nasal spray from Device B, once daily into each nostril, in the morning for 4 Weeks.
Drug: FFNS
FF as a aqueous suspension for intranasal inhalation with unit dose strength of 27.5 mcg per dose administered via a metered side-actuated nasal spray device.

Other: Placebo
Placebo as a aqueous suspension to match the other study treatments minus the active component(s) for intranasal inhalation administered via a metered side-actuated nasal spray device.

Experimental: FFNS 110 mcg Arm
Each subject will be dispensed with two nasal spray device labelled as Device A and Device B containing FF or Placebo. Subject's on their own or with assistance from parent/guardian will administer FFNS 110 mcg per day, one intranasal spray from Device A, once daily into each nostril (27.5 mcg per spray) and another spray of placebo nasal spray from Device B, once daily into each nostril, in the morning for 4 Weeks.
Drug: FFNS
FF as a aqueous suspension for intranasal inhalation with unit dose strength of 27.5 mcg per dose administered via a metered side-actuated nasal spray device.

Other: Placebo
Placebo as a aqueous suspension to match the other study treatments minus the active component(s) for intranasal inhalation administered via a metered side-actuated nasal spray device.

Placebo Comparator: Placebo Arm
Each subject will be dispensed with two nasal spray device labelled as Device A and Device B containing only placebo. Subject's on their own or with assistance from parent/guardian will administer one intranasal spray of placebo, from Device A and Device B, once daily into each nostril in the morning for 4 Weeks.
Other: Placebo
Placebo as a aqueous suspension to match the other study treatments minus the active component(s) for intranasal inhalation administered via a metered side-actuated nasal spray device.




Primary Outcome Measures :
  1. Mean Change From Baseline in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over the First 2 Weeks Treatment Period [ Time Frame: Baseline and up to Week 2 ]
    TNSS is a composite score of the four components (nasal congestion, itching, rhinorrhea and sneezing) with a total score of 0 to 12. A higher score means a worse nasal symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). Participants were instructed to provide scores in a reflective manner using their diary. The daily rTNSS was the average of the morning rTNSS and evening rTNSS assessments. The daily scores were averaged to calculate the overall/total score. The morning reflective assessment was performed prior to administering the morning dose. The evening reflective assessment was performed approximately 12 hours after dosing but before bedtime. Baseline scores obtained over "4 days prior to randomization" were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value.


Secondary Outcome Measures :
  1. Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale [ Time Frame: Week 2 ]
    Response was defined as effectiveness of study medication for relieving allergic rhinitis symptoms over the entire treatment period. Overall response to therapy was evaluated using the 7-point categorical scale ranging from 1 (significantly improved) to 7 (significantly worse). Number of participants showing response to therapy after the first 2 weeks have been presented. Only those participants with response to therapy over the entire treatment period were included in the analysis.

  2. Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 2 Weeks [ Time Frame: Baseline and up to Week 2 ]
    The nasal concha mucosa symptoms score was used to evaluate change in anterior rhinoscopy. It is a composite score of four components including swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume and description of rhinorrhea. Severity of each of the component was assessed using the scale ranging from 0 (no symptom) to 3 (severe). The 4 components were averaged to obtain a total score which ranges from 0 to 12 where a higher score means a worse nasal symptom. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified time points were included in the analysis.

  3. Mean Change From Baseline Over the First 2 Weeks in the Daily, Reflective Total Ocular Symptoms Score (rTOSS) [ Time Frame: Baseline and up to Week 2 ]
    TOSS is a composite score of the three components (eye itching and burning, eye watering and eye redness) with a total score of 0 to 9. Higher score means a worse symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). The daily scores were averaged to calculate the overall/total score. Participants were instructed to provide scores and document their symptoms in a reflective manner twice daily using their diary at the same time of reflective nasal symptoms assessment. Baseline scores obtained over "4 days prior to randomization" were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value

  4. Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 2 Weeks Treatment Period [ Time Frame: Baseline and up to Week 2 ]
    Loratadine was provided as a rescue medication to use if needed throughout the study treatment period. Participants were asked to document loratadine rescue medication use on the daily treatment diary. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value.

  5. Mean Change From Baseline in Daily rTNSS Over the 4 Weeks Treatment Period [ Time Frame: Baseline and up to Week 4 ]
    TNSS is a composite score of the four components (nasal congestion, itching, rhinorrhea and sneezing) with a total score of 0 to 12. A higher score means a worse nasal symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). Participants were instructed to provide scores in a reflective manner using their diary. The daily rTNSS was the average of the morning rTNSS and evening rTNSS assessments. The daily scores were averaged to calculate the overall/total score. The morning reflective assessment was performed prior to administering the morning dose. The evening reflective assessment was performed approximately 12 hours after dosing but before bedtime. Baseline scores obtained over "4 days prior to randomization" were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value.

  6. Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale [ Time Frame: Week 4 ]
    Response was defined as effectiveness of study medication for relieving allergic rhinitis symptoms over the entire treatment period. Overall response to therapy was evaluated using the 7-point categorical scale ranging from 1 (significantly improved) to 7 (significantly worse). Number of participants showing response to therapy after the first 4 weeks have been presented. Only those participants with response to therapy over the entire treatment period were included in the analysis.

  7. Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 4 Weeks [ Time Frame: Baseline and up to Week 4 ]
    The nasal concha mucosa symptoms score was used to evaluate change in anterior rhinoscopy. It is a composite score of four components including swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume and description of rhinorrhea. Severity of each of the component was assessed using the scale ranging from 0 (no symptom) to 3 (severe). The 4 components were averaged to obtain a total score which ranges from 0 to 12 where a higher score means a worse nasal symptom. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified time points were included in the analysis.

  8. Mean Change From Baseline in the Daily rTOSS Over the 4 Weeks Treatment Period [ Time Frame: Baseline and up to Week 4 ]
    TOSS is a composite score of the three components (eye itching and burning, eye watering and eye redness) with a total score of 0 to 9. Higher score means a worse symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). The daily scores were averaged to calculate the overall/total score. Participants were instructed to provide scores and document their symptoms in a reflective manner twice daily using their diary at the same time of reflective nasal symptoms assessment. Baseline scores obtained over "4 days prior to randomization" were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value.

  9. Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 4 Weeks Treatment Period [ Time Frame: Baseline and up to Week 4 ]
    Loratadine was provided as a rescue medication to use if needed throughout the study treatment period. Participants were asked to document loratadine rescue medication use on the daily treatment diary. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value.

  10. Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs During the Treatment Period [ Time Frame: Up to Week 4 ]
    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function.

  11. Number of Participants With Clinical Chemistry Values Outside the Normal Range [ Time Frame: Week 4 ]
    Blood samples were collected from participants at indicated time points to evaluate clinical chemistry values outside normal range. The clinical chemistry parameters including alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, creatinine, direct bilirubin, glucose, potassium, sodium, total bilirubin, total protein and blood urea nitrogen (BUN) with values outside normal range is presented. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

  12. Number of Participants With Hematology Values Outside Normal Range [ Time Frame: Week 4 ]
    Blood samples were collected from participants at indicated time points to evaluate hematology values outside normal range. The hematology parameters including basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes, platelet, red blood cells (RBC), total neutrophils, white blood cells (WBC) with values outside normal range is presented. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

  13. Number of Participants With Urinalysis Values Outside Normal Range [ Time Frame: Week 4 ]
    Urine parameters including urine specific gravity and urine potential of hydrogen (pH) with values outside normal range is presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

  14. Number of Participants With Change From Baseline in Nasal Examination [ Time Frame: Baseline and Week 4 ]
    A detailed nasal examination of the mucosa, septum, secretions, nasal patency, size of any polyps and ulcers was performed at specific time points. Number of participants with improved or worsened conditions are presented. Improved condition was defined as increase in number of patencies and Worsened condition was defined as decrease in number of patencies, from Baseline to Week 4. The Baseline value for a nasal examination was the most recent recorded value for Week 4 before dosing on Day 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

  15. Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [ Time Frame: Baseline and Week 4 ]
    Vital signs including SBP and DBP were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed.

  16. Change From Baseline in Heart Rate [ Time Frame: Baseline and Week 4 ]
    Vital signs including heart rate were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed.

  17. Change From Baseline in Temperature [ Time Frame: Baseline and Week 4 ]
    Vital signs including temperature were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed.

  18. Change From Baseline in Respiration Rate [ Time Frame: Baseline and Week 4 ]
    Vital signs including respiration rate were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed and dated informed consent obtained from the subject's parent/guardian.
  • Chinese male or non-child bearing potential female pediatric outpatients subjects who are >=2 to <=12 years of age at Visit 2.
  • Diagnosis of AR: Subjects must have a diagnosis of intermittent allergy rhinitis (IAR) [symptoms are present <4 days a week, or for <4 weeks] or persistent allergic rhinitis (PER) [symptoms are present >=4 days a week, or for >=4 weeks] by symptoms, physical signs skin prick test (SPT) and serum-specific immunoglobulin E (IgE) test. Subjects must have 2 or more symptoms of AR (watery rhinorrhea, nasal obstruction, nasal itching and sneezing), which are also present consecutively or accumulatively more than 1 hour on each day prior to Visit 1, or/and concomitant ocular symptoms: ocular itching, red eyes, watery eyes etc. The physical signs includes: nasal mucosa pale, oedema, nasal secretion. Allergic shiner and allergic crease in severity pediatric. A documented positive prick skin test and a positive serum specific IgE test using standardized allergen extract. A positive skin test is defined as a allergen wheal >=3 millimeters (mm), a histamine >=3 mm. Subjects have nasal symptoms described above or/and associated with ocular symptoms, as well as the nasal signs and one of laboratory test positive or demonstrate SPT represented a positive response or serum-specific IgE testing represented a positive response within 12 months prior to Visit 1.
  • Subject must be willing to maintain same environment throughout the study.
  • Subject and/or subject's parent/guardian understands and is willing, able and likely to comply with study procedures and restrictions as well as manage study drug administration.

Exclusion Criteria:

  • Concomitant Medical Conditions: (a) Significant concomitant medical conditions defined as historical or current evidence of clinically significant uncontrolled disease of any body system. Significant is defined as any disease that, in the opinion of the investigator, would confound the interpretation of the study results if the disease/condition exacerbated during the study: significant renal impairment, which based on the opinion of the investigator, would preclude the subjects' participation in the study and current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). (NOTES: Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice, or cirrhosis and Chronic stable hepatitis B and C [e.g., presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment] are acceptable if subject otherwise meets entry criteria). (b) A severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or frequent bleeding of the nose that could affect the deposition of double blind intranasal study drug. (c) Current or history of a Candida infection of the nose or oropharynx, shingles, chickenpox, measles, ocular herpes simplex. (d) Known hypersensitivity to corticosteroids or any excipients in the product. (e) Recent nasal septal surgery or nasal septal perforation. (f) Subjects start, discontinue or change desensitization treatment within 30 days prior to Visit 1. (g) Bacterial or viral infection of the eyes or upper respiratory tract within two weeks of Visit 1 or during the screening period. (h) Asthma, with the exception of mild intermittent asthma. (i) Diagnosis of rhinitis medicamentosa, vasomotor AR or eosinophil rhinitis.
  • Abnormal Laboratory Findings: A clinically significant laboratory abnormality including Liver Function Tests at Visit 1 meeting the following criteria: Alanine aminotransferase (ALT) >2 x upper limit of normal (ULN) and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]).
  • Abnormal Electocardiogram (ECG): Clinically significant abnormal ECG finding at Visit 1. Significant is defined as: Corrected QT (QTc) > 450 milliseconds (msec) or QTc > 480 msec in subjects with Bundle Branch Block. The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), Fridericia's formula (QTcF), and/or another method, machine-read or manually over-read. The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trail.
  • Concomitant Medication: Use of prescription or over-the-counter medication that would significantly affect the course of AR, or interact with study drug, such as: Chronic use of concomitant medications such as tricyclic antidepressants, that would affect assessment of the effectiveness of the study drug; Chronic use of long- acting beta2-agonists (e.g., salmeterol); Potent Cytochrome P450 subfamily enzyme 3A4 [CYP3A4] inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, etc); Allergen immunotherapy for the treatment of allergies.
  • Use of followings medications are not allowed throughout the study: Short-acting antihistamines, including ocular preparations and antihistamines contained in anti-cold medicine, insomnia or antalgic; Oral or inhaled anticholinergics; Oral or intranasal decongestants; Oral or intranasal antileukotrienes; Oral or inhaled long-acting beta2 agonists; Chinese traditional medicines that have potential effect to AR; Liquorice preparation; Medications that significantly inhibit the CYP3A4, including ritonavir and ketoconazole; tricyclic antidepressants; long-acting antihistamines( eg. desloratadine, fexofenadine, cetirizine and loratadine [ taken as rescue medication]); Intranasal antihistamines; or Intranasal or ocular cromolyh; Intranasal corticosteroids includes: Inhaled, oral, intramuscular, intravenous, ocular and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) and Immunosuppressive medications; Subcutaneous omalizumab.
  • Subjects will travel more than 48 hours during the study may cause the change of allergen.
  • Subjects, who, in the opinion of the Investigator or sub-investigators, are not able to comply with the protocol requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424539


Locations
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China, Fujian
GSK Investigational Site
Xiamen, Fujian, China, 361003
China, Guangdong
GSK Investigational Site
Shenzhen, Guangdong, China, 518038
China, Hunan
GSK Investigational Site
Changsha, Hunan, China, 410005
GSK Investigational Site
Changsha, Hunan, China, 410011
China, Jiangsu
GSK Investigational Site
Nanjing, Jiangsu, China, 210029
China, Shanxi
GSK Investigational Site
Taiyuan, Shanxi, China, 030016
China, Zhejiang
GSK Investigational Site
Wenzhou, Zhejiang, China, 323027
China
GSK Investigational Site
Beijing, China, 100034
GSK Investigational Site
Beijing, China
GSK Investigational Site
Changsha, China
GSK Investigational Site
Chongqing, China, 400014
GSK Investigational Site
Fuzhou, China, 350025
GSK Investigational Site
Hangzhou, China, 310052
GSK Investigational Site
Shanghai, China, 200040
GSK Investigational Site
Shanghai, China, 200092
GSK Investigational Site
Shanghai, China, 200127
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] January 15, 2016
Statistical Analysis Plan  [PDF] January 22, 2018


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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02424539    
Other Study ID Numbers: 201492
First Posted: April 23, 2015    Key Record Dates
Results First Posted: February 6, 2019
Last Update Posted: February 6, 2019
Last Verified: July 2018
Keywords provided by GlaxoSmithKline:
Seasonal
Fluticasone Furoate
Perennial
Allergic Rhinitis
Nasal Spray
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents