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

NCT02155881 | Completed Phase 3 Results

• 2 other identifiers: CIC-RR-001U1111-1152-9472
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Seasonal Allergic Rhinitis

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Nasal Symptom Scores

  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)

  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

  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

  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

  Baseline and Week 1 up to Week 2 (entire treatment period)

Study Arms (2)

Ciclesonide 200 mcg

EXPERIMENTAL

Ciclesonide 200 mcg nasal spray, 2 actuations (sprays) per nostril (50 mcg ciclesonide/actuation), daily, for 2 weeks.

Drug: Ciclesonide

Placebo

PLACEBO COMPARATOR

Ciclesonide placebo-matching nasal spray, 2 actuations (sprays) per nostril, daily, for 2 weeks.

Drug: Ciclesonide Placebo

Interventions

Ciclesonide DRUG

Ciclesonide nasal spray 50 mcg/actuation

Also known as: Omnaris®

Ciclesonide 200 mcg

Ciclesonide Placebo DRUG

Ciclesonide placebo-matching nasal spray

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (5)

Unknown Facility

Kazan', Russia

Location

Unknown Facility

Krasnodar, Russia

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Saratov, Russia

Location

Unknown Facility

Stavropol, Russia

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: AstraZeneca Clinical Study Information Center
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 4, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 2, 2017
• Results First Posted: October 6, 2016

Record last verified: 2016-12

Locations

RU (5)