- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00659048
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)
November 30, 2016 updated by: AstraZeneca
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
106
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229
- Altana/Nycomed
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female, 18 - 60 years of age.
- 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 for a minimum of one year immediately preceding the Screening Visit.
- 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.
- 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.
- 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).
- 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:
- 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 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).
- Participation in any investigational drug trial within the 30 days preceding the Screening Visit (S0).
- A known hypersensitivity to any corticosteroid or any of the excipients in the formulations.
- History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food.
- History of alcohol or drug abuse within the preceding two years.
- History of a positive test for HIV, hepatitis B or hepatitis C.
- Use of any prohibited concomitant medications within the prescribed (per protocol) withdrawal periods prior to the Screening Visit (S0) and during entire study duration.
- 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 (S0).
- 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.
- 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.
- Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables.
- Chronic or clinically relevant acute infections.
- Vegetarian diet or other unusual dietary habits that would preclude the subject's acceptance of standardized meals.
- Blood donation within the last 30 days before start of the study.
- Patients that do not have regular sleep patterns (e.g. working at night and sleeping during the daylight hours).
- Active asthma requiring treatment with inhaled or systemic corticosteroids; intermittent use of beta agonists is acceptable.
- 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.
- 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.
- 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.
- Failure to adequately understand and comply with the HFA-BDP instructions or failure to properly administer study medication.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
|
placebo
|
Active Comparator: 1
Ciclesonide 200µg
|
Ciclesonide 200µg versus Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
24 h plasma cortisol profiles and urinary cortisol
Time Frame: 53 days
|
53 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
24-hour urinary cortisol will be monitored at the following times
Time Frame: 53 days
|
53 days
|
Adverse events
Time Frame: 53 days
|
53 days
|
vital signs
Time Frame: 53 days
|
53 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
April 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
April 14, 2008
First Submitted That Met QC Criteria
April 15, 2008
First Posted (Estimate)
April 16, 2008
Study Record Updates
Last Update Posted (Estimate)
December 1, 2016
Last Update Submitted That Met QC Criteria
November 30, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Perennial
- Physiological Effects of Drugs
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Allergic Agents
- Ciclesonide
Other Study ID Numbers
- BY9010/M1-408
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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