A Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 3 Clinical Trial to Assess the Safety and Efficacy of Ciclesonide, Applied as a Nasal Spray (200µg Once Daily) in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 12 Years and Older

AstraZeneca1 site in 1 country302 target enrollmentDecember 2003

ConditionsRhinitis, Allergic, Seasonal Hay Fever

InterventionsPlacebo Ciclesonide

DrugsCiclesonide Placebo

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Rhinitis, Allergic, Seasonal
Sponsor: AstraZeneca
Enrollment: 302
Locations: 1
Primary Endpoint: Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over the first two weeks of treatment
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to demonstrate the efficacy of ciclesonide applied as a nasal spray once daily in patients with SAR. The secondary objectives are to evaluate Quality-of-Life and safety.

Registry

clinicaltrials.gov

Start Date

December 2003

End Date

February 2005

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female 12 years and older.
•General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the trial.
•A history of SAR to relevant seasonal allergen for a minimum of two years immediately preceding the study season. The SAR must have been of sufficient severity to have required treatment (continuous or intermittent) in the past and in the investigator's judgment, - is expected to require treatment throughout the entire study period.
•A demonstrated sensitivity to Mountain Cedar pollen known to induce SAR through a standard prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the control wheal for the prick test. Documentation of a positive result 12 months prior to screening is acceptable.
•Female is of child-bearing potential and is currently taking and will continue to use a medically reliable method of contraception for the entire study duration (e.g. oral, injectable, trans-cutaneous or implantable contraceptives or intrauterine devices or double-barrier protection). Women of childbearing potential, or less than 1 year postmenopausal, will require a negative serum pregnancy test at the Screening Visit (B0) as well as at last on-treatment visit (T4).
•Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and compliance with all study requirements (visits, record keeping, etc).

Exclusion Criteria

•Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the study period.
•History or physical findings of nasal pathology, including nasal polyps within the last 60 days) or other clinically significant respiratory tract malformations, recent nasal biopsy (within the last 60 days), nasal trauma, or surgery and atrophic rhinitis or rhinitis medicamentosa (within the last 60 days).
•Participation in any investigational drug trial within the 30 days preceding the Screening Visit.
•A known hypersensitivity to any corticosteroid or any of the excipients in the formulation.
•History of a respiratory infection or disorder \[including, but not limited to bronchitis, pneumonia, the common cold, acute or chronic sinusitis, flu, severe acute respiratory syndrome (SARS)\] within the 14 days preceding the Screening Visit, or development of a respiratory infection during the Screening Period.
•History of alcohol or drug abuse within the preceding two years.
•History of a positive test for HIV, hepatitis B or hepatitis C.
•Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of b-agonists; intermittent use of b-agonists is acceptable.
•Plans to travel outside the study area (the known pollen area for the investigative site) for two or more consecutive days OR 5 or more days total during the 5-week study period ( Baseline and Treatment Periods).
•Use of any prohibited concomitant medications within the prescribed (per protocol) time since last dose period prior to the Screening Visit (B0) and during entire treatment duration.

Arms & Interventions

2

Placebo

Intervention: Placebo

1

Ciclesonide 200µg

Intervention: Ciclesonide

Outcomes

Primary Outcomes

Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over the first two weeks of treatment

Time Frame: 4 weeks

Secondary Outcomes

Instantaneous patient-reported TNSS over the first two weeks of treatment(4 weeks)
Physician Assessment of Overall Nasal Signs and Symptoms Severity (PANS) at Endpoint(4 weeks)
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) at Endpoint(4 weeks)