Clinical trial NCT00659750: To Assess the Safety and Efficacy of Ciclesonide Applied as a Nasal Spray in the Treatment of Perennial Allergic Rhinitis (BY9010/M1-402)
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 (200 mg Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 12 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Keywords: Perennial Allergic Rhinitis
Ciclesonide
PAR
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-16
Enrollment: 418
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 PAR. The secondary objectives are to evaluate Quality-of-Life and safety.


Eligibility criteria: 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 PAR to relevant perennial allergen for a minimum of two years immediately preceding the study.The PAR 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 at least one allergen known to induce PAR 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. Additionally, the patient is expected to be exposed to the PAR allergen that he/she has tested positive for via the skin prick test for the duration of the study.
5. Female is of childbearing 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 (T6).
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 of 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 Baseline 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. 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.
10. 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.
11. 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.
12. Previous participation in an intranasal ciclesonide study.
13. Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit (B0).
14. Patients allergic to a seasonal aeroallergen, e.g. trees, grasses or weeds, with seasonal exacerbation anticipated to occur-or occurring-during the study.
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.

Primary outcomes:
measure: Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over 6 weeks of treatment.
timeFrame: 6 weeks
Secondary outcomes:
measure: Average of AM and PM patient-reported instantaneous TNSS over 6 weeks of treatment.
timeFrame: 6 weeks
measure: Physician Assessment of Overall Nasal Signs and Symptoms Severity (PANS) at Endpoint.
timeFrame: 6 weeks
measure: RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) at Endpoint
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Altana/Nycomed
state: California
city: Long Beach
country: United States
facility: Altana/Nycomed
state: California
city: Los Angeles
country: United States
facility: Altana/Nycomed
state: California
city: Mission Viejo
country: United States
facility: Altana/Nycomed
state: California
city: San Diego
country: United States
facility: Altana/Nycomed
state: California
city: San Jose
country: United States
facility: Altana/Nycomed
state: California
city: Colorado Springs
country: United States
facility: Altana/Nycomed
state: Colorado
city: Denver
country: United States
facility: Altana/Nycomed
state: Colorado
city: Denver
country: United States
facility: Altana/Nycomed
state: Colorado
city: Jupiter
country: United States
facility: Altana/Nycomed
state: Florida
city: Rockville
country: United States
facility: Altana/Nycomed
state: Maryland
city: North Dartmouth
country: United States
facility: Altana/Nycomed
state: Massachusetts
city: Minneapolis
country: United States
facility: Altana/Nycomed
state: Minnesota
city: St. Louis
country: United States
facility: Altana/Nycomed
state: Missouri
city: Missoula
country: United States
facility: Altana/Nycomed
state: Montana
city: Brick
country: United States
facility: Altana/Nycomed
state: New Jersey
city: Skillman
country: United States
facility: Altana/Nycomed
state: New Jersey
city: Raleigh
country: United States
facility: Altana/Nycomed
state: North Carolina
city: Winston-Salem
country: United States
facility: Altana/Nycomed
state: North Carolina
city: Sylvania
country: United States
facility: Altana/Nycomed
state: Ohio
city: Fort Worth
country: United States
facility: Altana/Nycomed
state: Texas
city: Houston
country: United States
facility: Altana/Nycomed
state: Texas
city: Madison
country: United States
facility: Altana/Nycomed
state: Wisconsin
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: