Efficacy and Safety of Ciclesonide Nasal Spray in Participants With Seasonal Allergic Rhinitis (SAR) in Russia
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Ciclesonide; Ciclesonide Placebo
Intervention description: Ciclesonide nasal spray 50 mcg/actuation; Ciclesonide placebo-matching nasal spray
Intervention MeSH terms: Ciclesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Informed consent signed by a participant for participation in the study.

          2. 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.

          3. 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.

          4. 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:

               1. 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;

               2. Barrier method of contraception, for example (eg), condom and/or diaphragm with
                  spermicide while participating in the study.

        Exclusion Criteria:

          1. 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.

          2. 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.

          3. Hypersensitivity to corticosteroid or any of the excipients in the formulation of
             ciclesonide.

          4. A history of respiratory tract infection or disorder within 2 weeks of the screening
             visit or had a respiratory tract infection during baseline.

          5. Presence of ocular herpes simplex or cataracts or a history of glaucoma.

          6. Active asthma requiring treatment with inhaled or systemic corticosteroids and/or
             routine use of beta (β)-agonists; intermittent use of β-agonists is acceptable.

          7. Use of intranasal immunosuppressive drugs for 30 days before Baseline.

          8. Female participant who is pregnant or lactating.

          9. 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.

         10. History of a positive test for human immunodeficiency virus (HIV), hepatitis B or
             hepatitis C.

         11. History of alcohol or drug abuse within the preceding two years.

         12. 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.

         13. 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.

         14. 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.

         15. 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.