To Assess the Safety and Efficacy of Ciclesonide, Applied as a Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (BY9010/M1-401)

Rhinitis, Allergic, Seasonal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659841
• Other study ID #: BY9010/M1-401
• Status: Completed
• Phase: Phase 3
• First received: April 14, 2008
• Last updated: December 1, 2016
• Start date: December 2003
• Est. completion date: February 2005

Study information

• Verified date: October 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: February 2005
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Male or female 12 years and older.

2. 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.

3. 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.

4. 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.

5. 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).

6. 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:

1. 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.

2. 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).

3. Participation in any investigational drug trial within the 30 days preceding the Screening Visit.

4. A known hypersensitivity to any corticosteroid or any of the excipients in the formulation.

5. 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.

6. History of alcohol or drug abuse within the preceding two years.

7. History of a positive test for HIV, hepatitis B or hepatitis C.

8. Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of b-agonists; intermittent use of b-agonists is acceptable.

9. 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).

10. 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.

11. Use of antibiotic therapy for acute conditions within 14 days prior to the Screening Visit (B0). Low doses of antibiotics taken for prophylaxis are permitted if the therapy was started prior to the Screening Visit AND is expected to continue throughout the trial.

12. 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 or more) may be considered for inclusion.

13. Previous participation in an intranasal ciclesonide study.

14. Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit (B0).

15. 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.

16. Use of topical corticosteroids in concentrations in excess of 1% 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hay Fever
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• Ciclesonide
200µg Ciclesonide versus placebo
• Placebo
placebo

Locations

Country	Name	City	State
United States	Altana/Nycomed	Austin	Texas
United States	Altana/Nycomed	Austin	Texas
United States	Altana/Nycomed	Kerrville	Texas
United States	Altana/Nycomed	New Braunfels	Texas
United States	Altana/Nycomed	San Antonio	Texas
United States	Altana/Nycomed	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over the first two weeks of treatment		4 weeks	No
Secondary	Instantaneous patient-reported TNSS over the first two weeks of treatment		4 weeks	No
Secondary	Physician Assessment of Overall Nasal Signs and Symptoms Severity (PANS) at Endpoint		4 weeks	No
Secondary	Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) at Endpoint		4 weeks	No

External Links

•   BY9010-M1-401-RDS-2004-12-21.pdf