Investigation of the Efficacy and Safety of Concomitant Administration of Ciclesonide Nasal Spray and Azelastine Nasal Spray in Patients (18 Years or Older) With Perennial Allergic Rhinitis (PAR) Not Adequately Controlled on an Intranasal Corticosteroid or Antihistamine Monotherapy (BY9010/M1-490)

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00806754
First received: December 10, 2008
Last updated: May 4, 2012
Last verified: December 2008
  Purpose
  • The primary objective of this study is to evaluate the efficacy of the concomitant administration of ciclesonide nasal spray and azelastine nasal spray versus ciclesonide nasal spray alone in patients (18 years or older) with perennial allergic rhinitis (PAR) not adequately controlled on an intranasal corticosteroid or antihistamine monotherapy
  • The secondary objective is to investigate the safety of the concomitant administration of ciclesonide nasal spray and azelastine nasal spray

Condition Intervention Phase
Rhinitis, Allergic, Perennial
Drug: Ciclesonide nasal spray + placebo Azelastine
Drug: Ciclesonide nasal spray + Azelastine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Investigation of the Efficacy and Safety of Concomitant Administration of Ciclesonide Nasal Spray and Azelastine Nasal Spray in Patients (18 Years or Older) With Perennial Allergic Rhinitis (PAR) Not Adequately Controlled on an Intranasal Corticosteroid or Antihistamine Monotherapy

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 the four weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total physician-assessed nasal symptoms score (PNSS) at Endpoint [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 340
Study Start Date: November 2006
Study Completion Date: August 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Ciclesonide nasal spray (50 mcg/spray, one spray per nostril) and placebo azelastine nasal spray ( two sprays per nostril) administered twice daily approximately 1 minute apart, once in the morning and 12 hours later, in the evening.
Drug: Ciclesonide nasal spray + placebo Azelastine
Ciclesonide nasal spray 50 mcg + Placebo Azelastine
Active Comparator: 2
Ciclesonide nasal spray (50 mcg/spray, one spray per nostril) and azelastine nasal spray (137 mcg/spray, two sprays per nostril) administered twice daily approximately 1 minute apart, once in the morning and 12 hours later, in the evening.
Drug: Ciclesonide nasal spray + Azelastine
Ciclesonide nasal spray 50 mcg + Azelastine 137 mcg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 18 years of age or older at the B0 Visit.
  2. General good health, and free of any concomitant conditions or treatment that in the investigator's judgment 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 for a minimum of two years immediately preceding the Screening Visit (B0). The PAR must have been of sufficient severity to require treatment(continuous or intermittent) in the past with intranasal corticosteroids and/or antihistamines and, in the investigator's judgment, experienced less than complete symptom alleviation on this prior therapy. In addition, the patient is again expected to require treatment throughout the study period.
  4. A demonstrated sensitivity to at least one allergen known to induce PAR through a standard prick test within one year of study start. A positive test is defined as a wheal diameter at least 3 mm larger than the control (saline) wheal for the prick test. Documentation of a positive result within 12 months prior to the Screening Visit (B0) is acceptable.
  5. Females of childbearing potential currently using contraception must 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).Females who are not sexually active must agree to use double-barrier protection should they become active during the course of the study. Women of childbearing potential, or less than 1 year postmenopausal, will require a negative plasma pregnancy test at the Screening Visit (B0). Females will be considered to be of non-child-bearing potential and will not require a urine pregnancy test if at least one of the following apply:

    • More than one year post-menopausal
    • Had a hysterectomy
    • Had bilateral ovariectomy or salpingectomy or tubal ligation
    • Has congenital sterility
  6. Patients on intranasal corticosteroids and antihistamines should be on a stable dose for at least 4 weeks.
  7. Patients must complete a 24-hour reflective total nasal symptom assessment at the Screening Visit (B0) and score a total of 6 or greater (out of 12).

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 intranasal corticosteroid, antihistamine 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. 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. Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit (B0).
  13. 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.
  14. 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.
  15. History of epilepsy or seizures (excluding febrile seizures).
  16. History of coronary artery disease, uncontrolled hypertension, or other clinically significant cardiovascular disease.
  17. Patients using combination treatment for allergic rhinitis (e.g. intranasal corticosteroid and antihistamine).
  18. Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult:

    • Impaired hepatic function including alcohol-related liver disease or cirrhosis;
    • History of ocular disturbances e.g. glaucoma or posterior subcapsular cataracts;
    • Any systemic infection;
    • Hematological, hepatic, renal, endocrine (except for controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism);· Gastrointestinal disease;
    • Malignancy (excluding basal cell carcinoma).
  19. Clinical site employees and their immediate relatives are excluded from study participation.
  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: NCT00806754

  Show 35 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Nycomed Clinical Trial Management Headquarter
  More Information

No publications provided

Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00806754     History of Changes
Other Study ID Numbers: BY9010/M1-490
Study First Received: December 10, 2008
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

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
Histamine Antagonists
Azelastine
Histamine H1 Antagonists
Ciclesonide
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Lipoxygenase Inhibitors
Enzyme Inhibitors
Anti-Allergic Agents
Therapeutic Uses
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 26, 2014