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Sponsored by: |
Sepracor, Inc. |
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Information provided by: | Sepracor, Inc. |
ClinicalTrials.gov Identifier: | NCT00790023 |
To demonstrate the efficacy of ciclesonide HFA applied as a nasal aerosol (160 μg and 80 μg) once daily compared to placebo in subjects with SAR.
Condition | Intervention | Phase |
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Seasonal Allergic Rhinitis |
Drug: 80 mcg Ciclesonide Drug: 160 mcg Ciclesonide Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Multicenter, Double Blind, Placebo Controlled, Parallel Group, Phase III Clinical Trial to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol (160 μg Once Daily and 80 μg Once Daily) for the Treatment of Seasonal Allergic Rhinitis (SAR) to Mountain Cedar in Subjects 12 Years and Older. |
Enrollment: | 660 |
Study Start Date: | November 2008 |
Study Completion Date: | February 2009 |
Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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80 mcg Ciclesonide: Experimental
80 ug Ciclesonide once daily
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Drug: 80 mcg Ciclesonide
80 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril)
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160 mcg Ciclesonide: Experimental
160 mcg Ciclesonide once daily
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Drug: 160 mcg Ciclesonide
160 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril)
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Placebo: Placebo Comparator
Placebo
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Drug: Placebo
Placebo HFA Inhaler once daily (one actuation per nostril)
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This is a randomized, double blind, placebo controlled, parallel group, multicenter study to demonstrate the efficacy of ciclesonide HFA applied as a nasal aerosol (160 μg and 80 μg) once daily compared to placebo in subjects with SAR.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject, if female 65 years of age or younger, must have a negative serum pregnancy test (performed at Visit 1) prior to randomization at Visit 2. Women of childbearing potential (excluding females at least two years postmenopausal or surgically sterile) must sign the Women of Childbearing Potential Addendum to the informed consent form. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:
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: impaired hepatic function including alcohol-related liver disease or cirrhosis;
United States, Texas | |
San Antonio, Texas, United States, 78229 | |
New Braunfels, Texas, United States, 78130 | |
Kerrville, Texas, United States, 78028 | |
Austin, Texas, United States, 78731 |
Responsible Party: | Sepracor Inc. ( Ciclesonide Medical Director ) |
Study ID Numbers: | 060-622 |
Study First Received: | November 11, 2008 |
Last Updated: | August 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00790023 History of Changes |
Health Authority: | United States: Food and Drug Administration |
SAR |
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 |