To Assess the Safety and Efficacy of Ciclesonide Applied as a Nasal Spray in the Treatment of Perennial Allergic Rhinitis (BY9010/M1-402)

NCT00659750 | Completed Phase 3

• 1 other identifier: BY9010/M1-402
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 23

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.

Conditions

Rhinitis, Allergic, Perennial

Keywords

Perennial Allergic Rhinitis; Ciclesonide; PAR

Outcome Measures

Primary Outcomes (1)

• Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over 6 weeks of treatment.

  6 weeks

Secondary Outcomes (3)

• Average of AM and PM patient-reported instantaneous TNSS over 6 weeks of treatment.

  6 weeks

• Physician Assessment of Overall Nasal Signs and Symptoms Severity (PANS) at Endpoint.

  6 weeks

• RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) at Endpoint

  6 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Ciclesonide 200µg

Drug: Ciclesonide

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Ciclesonide DRUG

200µg Ciclesonide versus Placebo

1

Placebo DRUG

placebo

2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.
• 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.
• 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).
• 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).

You may not qualify if:

• 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 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).
• 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 Baseline 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.
• 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.
• 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.
• Previous participation in an intranasal ciclesonide study.
• Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit (B0).
• Patients allergic to a seasonal aeroallergen, e.g. trees, grasses or weeds, with seasonal exacerbation anticipated to occur-or occurring-during the study.
• 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% 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 (23)

Altana/Nycomed

Encinitas, California, 92924, United States

Location

Altana/Nycomed

Long Beach, California, 90806, United States

Location

Altana/Nycomed

Los Angeles, California, 90025, United States

Location

Altana/Nycomed

Mission Viejo, California, 92691, United States

Location

Altana/Nycomed

San Diego, California, 92123, United States

Location

Altana/Nycomed

San Jose, California, 95117, United States

Location

Altana/Nycomed

Colorado Springs, Colorado, 80907, United States

Location

Altana/Nycomed

Denver, Colorado, 80206, United States

Location

Altana/Nycomed

Denver, Colorado, 80230, United States

Location

Altana/Nycomed

Jupiter, Florida, 33458, United States

Location

Altana/Nycomed

Rockville, Maryland, 20850, United States

Location

Altana/Nycomed

North Dartmouth, Massachusetts, 02747, United States

Location

Altana/Nycomed

Minneapolis, Minnesota, 55402, United States

Location

Altana/Nycomed

St Louis, Missouri, 63141, United States

Location

Altana/Nycomed

Missoula, Montana, 59804, United States

Location

Altana/Nycomed

Brick, New Jersey, 08724, United States

Location

Altana/Nycomed

Skillman, New Jersey, 08558, United States

Location

Altana/Nycomed

Raleigh, North Carolina, 27607, United States

Location

Altana/Nycomed

Winston-Salem, North Carolina, 27103, United States

Location

Altana/Nycomed

Sylvania, Ohio, 43560, United States

Location

Altana/Nycomed

Fort Worth, Texas, 76132, United States

Location

Altana/Nycomed

Houston, Texas, 77084, United States

Location

Altana/Nycomed

Madison, Wisconsin, 53792-9988, United States

Location

Related Links

• BY9010-M1-402-RDS-2005-04-05.pdf

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

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

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 14, 2008
• First Posted: April 16, 2008
• Study Start: December 1, 2003
• Primary Completion: May 1, 2004
• Study Completion: April 1, 2005
• Last Updated: December 2, 2016

Record last verified: 2016-10

Locations

US (23)