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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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)

NCT00806754•AstraZeneca

View on ClinicalTrials.gov

Summary

* 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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.
+14 more criteria

Locations (35)

Altana/Nycomed

Encinitas, California, United States

Altana/Nycomed

Los Angeles, California, United States

Altana/Nycomed

Mission Viejo, California, United States

Altana/Nycomed

San Diego, California, United States

Altana/Nycomed

San Jose, California, United States

Altana/Nycomed

Colorado Springs, Colorado, United States

Altana/Nycomed

Denver, Colorado, United States

Altana/Nycomed

Lakewood, Colorado, United States

Altana/Nycomed

Gainesville, Georgia, United States

Altana/Nycomed

Savannah, Georgia, United States

Key Dates

Start Date

November 1, 2006

Primary Completion Date

May 1, 2007

Completion Date

August 1, 2007

Last Updated

November 23, 2016

Enrollment

340

ACTUAL participants

Conditions

Rhinitis, Allergic, Perennial

Interventions

Ciclesonide nasal spray + placebo Azelastine

DRUG

Ciclesonide nasal spray + Azelastine

DRUG

A Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis (Study P03748)(COMPLETED)

NCT00779545

Rhinitis, Allergic, Perennial

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COMPLETEDPHASE3

Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683)

NCT00406783

Rhinitis, Allergic, SeasonalRhinitis, Allergic, Perennial

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 23, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

A Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis (Study P03748)(COMPLETED)

Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683)

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