- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00659841
To Assess the Safety and Efficacy of Ciclesonide, Applied as a Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (BY9010/M1-401)
December 1, 2016 updated by: AstraZeneca
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 (200µg Once Daily) in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 12 Years and Older
The primary objective of this study is to demonstrate the efficacy of ciclesonide applied as a nasal spray once daily in patients with SAR.
The secondary objectives are to evaluate Quality-of-Life and safety.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
302
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
-
Austin, Texas, United States, 78731
- Altana/Nycomed
-
Austin, Texas, United States, 78759
- Altana/Nycomed
-
Kerrville, Texas, United States, 78028
- Altana/Nycomed
-
New Braunfels, Texas, United States, 78130
- Altana/Nycomed
-
San Antonio, Texas, United States, 78229
- Altana/Nycomed
-
San Antonio, Texas, United States, 78205
- 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
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female 12 years and older.
- 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 SAR to relevant seasonal allergen for a minimum of two years immediately preceding the study season. The SAR 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.
- A demonstrated sensitivity to Mountain Cedar pollen known to induce SAR 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.
- Female is of child-bearing 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 (T4).
- 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:
- 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.
- A known hypersensitivity to any corticosteroid or any of the excipients in the formulation.
- 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.
- History of alcohol or drug abuse within the preceding two years.
- History of a positive test for HIV, hepatitis B or hepatitis C.
- Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of b-agonists; intermittent use of b-agonists is acceptable.
- Plans to travel outside the study area (the known pollen area for the investigative site) for two or more consecutive days OR 5 or more days total during the 5-week study period ( Baseline and Treatment Periods).
- 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.
- 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.
- 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.
- 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 (B0).
- 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.
- 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.
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
|
placebo
|
Active Comparator: 1
Ciclesonide 200µg
|
200µg Ciclesonide versus placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over the first two weeks of treatment
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Instantaneous patient-reported TNSS over the first two weeks of treatment
Time Frame: 4 weeks
|
4 weeks
|
Physician Assessment of Overall Nasal Signs and Symptoms Severity (PANS) at Endpoint
Time Frame: 4 weeks
|
4 weeks
|
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) at Endpoint
Time Frame: 4 weeks
|
4 weeks
|
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, 2003
Primary Completion (Actual)
December 1, 2004
Study Completion (Actual)
February 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 2, 2016
Last Update Submitted That Met QC Criteria
December 1, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
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, Seasonal
- Physiological Effects of Drugs
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Allergic Agents
- Ciclesonide
Other Study ID Numbers
- BY9010/M1-401
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.
Clinical Trials on Rhinitis, Allergic, Seasonal
-
Glenmark Specialty S.A.CompletedSeasonal Allergic Rhinitis (SAR)United States
-
UCB PharmaCompleted
-
UCB PharmaCompletedRhinitis | Allergic | Seasonal
-
SanofiCompleted
-
Glenmark Specialty S.A.CompletedSeasonal Allergic Rhinitis (SAR)United States
-
SanofiCompleted
-
BayerCompletedRhinitis | Seasonal Rhinitis
-
GlaxoSmithKlineCompletedRhinitis, Allergic, Perennial and SeasonalUnited States
-
University of East AngliaNorfolk and Norwich University Hospitals NHS Foundation Trust; Quadram Institute... and other collaboratorsCompletedAsthma | Grass Allergy | Seasonal Affective RhinitisUnited Kingdom
-
ALK-Abelló A/SCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States