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Sponsored by: |
ALTANA Pharma |
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Information provided by: | ALTANA Pharma |
ClinicalTrials.gov Identifier: | NCT00659503 |
The primary objective of this placebo-controlled EEU study is to determine the time to onset of action of ciclesonide, applied as a nasal spray (200 mg, once daily) in patients with SAR.
Condition | Intervention | Phase |
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Rhinitis, Allergic, Seasonal Hay Fever |
Drug: Ciclesonide Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Using the Environmental Exposure Unit (EEU) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray (200 mg, Once Daily), in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 18 Years and Older |
Enrollment: | 420 |
Study Start Date: | February 2005 |
Study Completion Date: | November 2005 |
Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Ciclesonide 200µg
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Drug: Ciclesonide
200µg Ciclesonide versus Placebo
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2: Placebo Comparator
Placebo
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Drug: Placebo
placebo
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Female is of child-bearing potential and is currently using 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). Females who are not sexually active must agree to use double-barrier protection should they become sexually active during the course of the study. Women of child-bearing potential, or less than 1 year postmenopausal, will require a negative urine pregnancy test at the Screening Visit (B0) as well as prior to initiation of treatment at Treatment Visit (T0).Female subjects will be considered of non-childbearing potential and will not require a urine pregnancy test if at least one of the following apply:
Exclusion Criteria:
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:
Responsible Party: | Nycomed ( Nycomed ) |
Study ID Numbers: | BY9010/M1-407 |
Study First Received: | April 14, 2008 |
Last Updated: | April 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00659503 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Authority |
Seasonal Allergic Rhinitis Ciclesonide Hay Fever SAR |
Fever Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases Ciclesonide |
Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Rhinitis Anti-Allergic Agents Respiratory Hypersensitivity |
Otorhinolaryngologic Diseases Immune System Diseases Ciclesonide Rhinitis Anti-Allergic Agents Pharmacologic Actions Nose Diseases |
Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis, Allergic, Seasonal Therapeutic Uses Hypersensitivity, Immediate Respiratory Hypersensitivity |