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

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00659750
First received: April 14, 2008
Last updated: May 4, 2012
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Rhinitis, Allergic, Perennial
Drug: Ciclesonide
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over 6 weeks of treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average of AM and PM patient-reported instantaneous TNSS over 6 weeks of treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Physician Assessment of Overall Nasal Signs and Symptoms Severity (PANS) at Endpoint. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) at Endpoint [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 418
Study Start Date: December 2003
Study Completion Date: April 2005
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Ciclesonide 200µg
Drug: Ciclesonide
200µg Ciclesonide versus Placebo
Placebo Comparator: 2
Placebo
Drug: Placebo
placebo

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659750

Locations
United States, California
Altana/Nycomed
Encinitas, California, United States, 92924
Altana/Nycomed
Long Beach, California, United States, 90806
Altana/Nycomed
Los Angeles, California, United States, 90025
Altana/Nycomed
Mission Viejo, California, United States, 92691
Altana/Nycomed
San Diego, California, United States, 92123
Altana/Nycomed
San Jose, California, United States, 95117
United States, Colorado
Altana/Nycomed
Colorado Springs, Colorado, United States, 80907
Altana/Nycomed
Denver, Colorado, United States, 80206
Altana/Nycomed
Denver, Colorado, United States, 80230
United States, Florida
Altana/Nycomed
Jupiter, Florida, United States, 33458
United States, Maryland
Altana/Nycomed
Rockville, Maryland, United States, 20850
United States, Massachusetts
Altana/Nycomed
North Dartmouth, Massachusetts, United States, 02747
United States, Minnesota
Altana/Nycomed
Minneapolis, Minnesota, United States, 55402
United States, Missouri
Altana/Nycomed
St. Louis, Missouri, United States, 63141
United States, Montana
Altana/Nycomed
Missoula, Montana, United States, 59804
United States, New Jersey
Altana/Nycomed
Brick, New Jersey, United States, 08724
Altana/Nycomed
Skillman, New Jersey, United States, 08558
United States, North Carolina
Altana/Nycomed
Raleigh, North Carolina, United States, 27607
Altana/Nycomed
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Altana/Nycomed
Sylvania, Ohio, United States, 43560
United States, Texas
Altana/Nycomed
Fort Worth, Texas, United States, 76132
Altana/Nycomed
Houston, Texas, United States, 77084
United States, Wisconsin
Altana/Nycomed
Madison, Wisconsin, United States, 53792-9988
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Nycomed Clinical trial Management Headquarters
  More Information

No publications provided

Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00659750     History of Changes
Other Study ID Numbers: BY9010/M1-402
Study First Received: April 14, 2008
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Authority

Keywords provided by Takeda:
Perennial Allergic Rhinitis
Ciclesonide
PAR

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ciclesonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014