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

Study identifier:CIC-RR-001

ClinicalTrials.gov identifier:NCT02155881

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Seasonal Allergic Rhinitis

Phase

Phase 3

Healthy volunteers

Study drug

Ciclesonide, Ciclesonide Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Aug 2014

Primary Completion Date: 01 Oct 2014

Study Completion Date: 01 Nov 2014

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2016 by AstraZeneca

Collaborators

Inclusion and exclusion 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:
a. 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;
b. 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.

Location

Moscow, Russian Federation

Location

Saratov, Russian Federation

Location

Kazan, Russian Federation

Location

Stavropol, Russian Federation

Location

Krasnodar, Russian Federation

Arms	Assigned Interventions
Experimental: Ciclesonide 200 mcg Ciclesonide 200 mcg nasal spray, 2 actuations (sprays) per nostril (50 mcg ciclesonide/actuation), daily, for 2 weeks.	Drug: Ciclesonide Ciclesonide nasal spray 50 mcg/actuation Other Name: Omnaris®
Placebo Comparator: Placebo Ciclesonide placebo-matching nasal spray, 2 actuations (sprays) per nostril, daily, for 2 weeks.	Drug: Ciclesonide Placebo Ciclesonide placebo-matching nasal spray

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

AstraZeneca AstraZeneca

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Trial Results Summaries