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Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray When Administered Concomitantly With Orally Inhaled Beclomethasone Dipropionate (HFA-BDP) in Patients With Perennial Allergic Rhinitis (PAR) (BY9010/M1-408)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00659048
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : December 1, 2016
Information provided by (Responsible Party):

Brief Summary:
The primary objective of this study is to demonstrate that there are no clinically relevant additive inhibitory effects on the HPA-axis when ciclesonide nasal spray is concomitantly administered with orally inhaled HFA-BDP. The secondary objectives are to evaluate safety and tolerability of the combined dosing regimen of orally inhaled HFA-BDP and ciclesonide nasal spray.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Perennial Drug: Ciclesonide Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray When Administered Concomitantly With Orally Inhaled Beclomethasone Dipropionate (HFA-BDP) in Patients (18-60 Years) With Perennial Allergic Rhinitis (PAR)
Study Start Date : December 2004
Actual Primary Completion Date : April 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Ciclesonide 200µg
Drug: Ciclesonide
Ciclesonide 200µg versus Placebo

Placebo Comparator: 2
Drug: Placebo

Primary Outcome Measures :
  1. 24 h plasma cortisol profiles and urinary cortisol [ Time Frame: 53 days ]

Secondary Outcome Measures :
  1. 24-hour urinary cortisol will be monitored at the following times [ Time Frame: 53 days ]
  2. Adverse events [ Time Frame: 53 days ]
  3. vital signs [ Time Frame: 53 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female, 18 - 60 years of age.
  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 for a minimum of one year immediately preceding the Screening Visit.
  4. A demonstrated sensitivity to at least one allergen known to induce PAR through a standard prick or intradermal test. A positive test is defined as a wheal diameter at least 3 mm larger than the control wheal for the prick test, and 7 mm or greater than the control for the intradermal test. Documentation of a positive result within 12 months prior to the Screening Visit is acceptable.
  5. Females of child-bearing potential are 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 plasma pregnancy test at the Screening Visit as well as at last on-treatment visit.
  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).
  7. Normal body weight as evidenced by a Body Mass Index (BMI) between ³ 18 and 31 kg/m², and a body weight > 45 kg.

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 or 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 (S0).
  4. A known hypersensitivity to any corticosteroid or any of the excipients in the formulations.
  5. History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food.
  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. Use of any prohibited concomitant medications within the prescribed (per protocol) withdrawal periods prior to the Screening Visit (S0) and during entire study duration.
  9. Previous participation in an intranasal ciclesonide study.
  10. Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit (S0).
  11. Exposure to corticosteroids for any indication, chronic or intermittent (e.g.: asthma, 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.
  12. Use of topical corticosteroids in concentrations in excess of the equivalent 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.
  13. Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables.
  14. Chronic or clinically relevant acute infections.
  15. Vegetarian diet or other unusual dietary habits that would preclude the subject's acceptance of standardized meals.
  16. Blood donation within the last 30 days before start of the study.
  17. Patients that do not have regular sleep patterns (e.g. working at night and sleeping during the daylight hours).
  18. Active asthma requiring treatment with inhaled or systemic corticosteroids; intermittent use of beta agonists is acceptable.
  19. 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 (S0), or development of a respiratory infection during the Run-in Period.
  20. Use of antibiotic therapy for acute conditions within 14 days prior to the Screening Visit (S0). Low doses of antibiotics taken for prophylaxis are permitted if the therapy was started prior to the Screening Visit (S0) AND is expected to continue throughout the trial.
  21. 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 (S0) AND use of a stable (maintenance) dose (30 days or more) may be considered for inclusion.
  22. Failure to adequately understand and comply with the HFA-BDP instructions or failure to properly administer study medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00659048

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United States, Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
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Study Director: AstraZeneca AstraZeneca AstraZeneca

Additional Information:
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Responsible Party: AstraZeneca Identifier: NCT00659048     History of Changes
Other Study ID Numbers: BY9010/M1-408
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: October 2016
Keywords provided by AstraZeneca:
Perennial Allergic Rhinitis
Additional relevant MeSH terms:
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Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Allergic Agents