Efficacy and Safety of Ciclesonide Nasal Spray in Participants With Seasonal Allergic Rhinitis (SAR) in Russia

Study Overview
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Brief Summary
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The purpose of this study is to explore the efficacy and safety of Ciclesonide Nasal Spray 200 microgram (mcg) once daily in the treatment of seasonal allergic rhinitis (SAR) in Russian participants.

Detailed Description
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The drug being tested in this study is called ciclesonide. Ciclesonide is being tested to treat allergy symptoms in people who have SAR. This study will look at improvement of allergy symptoms in Russian participants who take ciclesonide nasal spray. The study will enroll approximately 80 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): Ciclesonide nasal spray 200 mcg Placebo nasal spray (dummy inactive nasal spray) - this is a nasal spray that looks like the study drug but has no active ingredient. All participants will be asked to take 2 actuations per nostril at the same time each day throughout the study, and will be asked to record the severity of their allergy symptoms twice a day in a diary. This multi-centre trial will be conducted in Russia. The overall time to participate in this study is up to 5 weeks. Participants will make 3 visits to the clinic, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Official Title
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A Multi-Center, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group, Phase III (Registration) Study to Assess the Efficacy and Safety of Ciclesonide Nasal Spray (Omnaris®) 200 mcg Once Daily in the Treatment of the Patients With Seasonal Allergic Rhinitis (SAR) in Russia

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: Ciclesonide
* Drug: Ciclesonide Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent signed by a participant for participation in the study. SAR male and female participants aged greater than or equal to (>=) 18 years (with a history of SAR of 2 years on longer). In the Investigator's judgment the SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) during this period, and was expected to require treatment for the duration of the study. To have a demonstrated positive skin prick test or other serologic tests to at least 1 relevant seasonal allergen. A positive skin test is generally defined as a wheal 3 mm larger than the diluents control wheal for prick testing. If female less than or equal to (<=) 65 years of age, must have a negative urine pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control: An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation; Barrier method of contraception, for example (eg), condom and/or diaphragm with spermicide while participating in the study. Exclusion Criteria: Nasal pathology, including nasal polyps, clinically relevant respiratory tract malformations, recent nasal biopsy (within 60 days), nasal trauma, nasal surgery, atrophic rhinitis, rhinitis medicamentosa (within 60 days), vasomotor rhinitis. Initiation of immunotherapy during the study period or dose escalation during the study period. However, initiation of immunotherapy 90 days or more prior to the Screening Visit AND use of a stable (maintenance) dose (30 days more) may be considered for inclusion. Hypersensitivity to corticosteroid or any of the excipients in the formulation of ciclesonide. A history of respiratory tract infection or disorder within 2 weeks of the screening visit or had a respiratory tract infection during baseline. Presence of ocular herpes simplex or cataracts or a history of glaucoma. Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta (β)-agonists; intermittent use of β-agonists is acceptable. Use of intranasal immunosuppressive drugs for 30 days before Baseline. Female participant who is pregnant or lactating. Participation in any investigational drug trial within the 30 days preceding the Screening Visit or planned participation in another investigational drug trial at any time during this trial. History of a positive test for human immunodeficiency virus (HIV), hepatitis B or hepatitis C. History of alcohol or drug abuse within the preceding two years. Use of any prohibited concomitant medications within the prescribed (per protocol) time spent last dose period to the Screening Visit (Visit 0) and during entire treatment duration. Any condition that, in the judgment of the investigator, can be clinically significant and/or affect the participant's ability to participate in the clinical trial. Exposure to systemic corticosteroids for any indication, chronic or intermittent (e.g.: contact dermatitis), during the past 2 months, or presence of an underlying condition that can reasonably be expected to require treatment with corticosteroids during the course of the study. Use of topical corticosteroids in concentrations in excess of 1 percent (%) hydrocortisone for dermatological conditions during the past 1 month, or presence of an underlying condition that can reasonably be expected to require treatment with such preparations during the course of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ciclesonide 200 mcg<br>Ciclesonide 200 mcg nasal spray, 2 actuations (sprays) per nostril (50 mcg ciclesonide/actuation), daily, for 2 weeks. | Drug: Ciclesonide<br>* Ciclesonide nasal spray 50 mcg/actuation<br>* Other names: Omnaris®;|
| Placebo Comparator: Placebo<br>Ciclesonide placebo-matching nasal spray, 2 actuations (sprays) per nostril, daily, for 2 weeks. | Drug: Ciclesonide Placebo<br>* Ciclesonide placebo-matching nasal spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Nasal Symptom Scores (TNSS) | The reflective TNSS is defined as the sum of the participant-rated reflective symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score. | Baseline and Week 1 up to Week 2 (entire treatment period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Nasal Symptom Scores | The instantaneous TNSS is defined as the sum of the participant-rated instantaneous symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion at the time of evaluation. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score. | Baseline and Week 1 up to Week 2 (entire treatment period) | 
| Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Ocular Symptom Scores (TOSS) | The reflective TOSS is defined as the sum of the participant-rated reflective symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Reflective TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score. | Baseline and Week 1 up to Week 2 (entire treatment period) | 
| Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Ocular Symptom Scores | The instantaneous TOSS is defined as the sum of the participant-rated instantaneous symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes at the time of evaluation. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Instantaneous TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score. | Baseline and Week 1 up to Week 2 (entire treatment period) | 
| Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score | The reflective TNSS is defined as the sum of the participant-rated reflective symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score. | Baseline and Week 1 up to Week 2 (entire treatment period) | 
| Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Ocular Symptom Score | The reflective TOSS is defined as the sum of the participant-rated reflective symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Reflective TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score. | Baseline and Week 1 up to Week 2 (entire treatment period) | 
| Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score | The RQLQ is a 28-item, disease-specific quality of life questionnaire that measures the functional (physical, emotional, and social) problems troublesome to adults with allergies. The RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional). All 28 questions were evaluated by the participant in an assessment diary over 2 weeks of treatment period and was rated on a 7-point severity scale ranging from 0 to 6, where 0 = least severe to 6 = extremely severe. Overall total score was calculated by taking the mean of the response of all individual 28 questions. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score. | Baseline and Week 1 up to Week 2 (entire treatment period) | 
| Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score | The RQLQ is a 28-item, disease-specific quality of life questionnaire that measures the functional (physical, emotional, and social) problems troublesome to adults with allergies. The RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional). All 28 questions were evaluated by the participant in an assessment diary over 2 weeks of treatment period and was rated on a 7-point severity scale ranging from 0 to 6, where 0 = least severe to 6 = extremely severe. Overall domain scores were calculated by taking the mean of the response of the relevant questions. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score. | Baseline and Week 1 up to Week 2 (entire treatment period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug therapy