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| Sponsor: | ALTANA Pharma |
|---|---|
| Information provided by: | ALTANA Pharma |
| ClinicalTrials.gov Identifier: | NCT00806754 |
Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Rhinitis, Allergic, Perennial |
Drug: Ciclesonide nasal spray + placebo Azelastine Drug: Ciclesonide nasal spray + Azelastine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Investigation of the Efficacy and Safety of Concomitant Administration of Ciclesonide Nasal Spray and Azelastine Nasal Spray in Patients (18 Years or Older) With Perennial Allergic Rhinitis (PAR) Not Adequately Controlled on an Intranasal Corticosteroid or Antihistamine Monotherapy |
| Enrollment: | 340 |
| Study Start Date: | November 2006 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Ciclesonide nasal spray (50 mcg/spray, one spray per nostril) and placebo azelastine nasal spray ( two sprays per nostril) administered twice daily approximately 1 minute apart, once in the morning and 12 hours later, in the evening.
|
Drug: Ciclesonide nasal spray + placebo Azelastine
Ciclesonide nasal spray 50 mcg + Placebo Azelastine
|
|
Active Comparator: 2
Ciclesonide nasal spray (50 mcg/spray, one spray per nostril) and azelastine nasal spray (137 mcg/spray, two sprays per nostril) administered twice daily approximately 1 minute apart, once in the morning and 12 hours later, in the evening.
|
Drug: Ciclesonide nasal spray + Azelastine
Ciclesonide nasal spray 50 mcg + Azelastine 137 mcg
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Females of childbearing potential currently using contraception must 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 active during the course of the study. Women of childbearing potential, or less than 1 year postmenopausal, will require a negative plasma pregnancy test at the Screening Visit (B0). Females will be considered to be of non-child-bearing 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, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult:
Contacts and Locations
Show 35 Study Locations| Study Chair: | Nycomed Clinical Trial Management | Headquarter |
More Information
| Responsible Party: | Nycomed |
| ClinicalTrials.gov Identifier: | NCT00806754 History of Changes |
| Other Study ID Numbers: | BY9010/M1-490 |
| Study First Received: | December 10, 2008 |
| Last Updated: | December 10, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Perennial Allergic Rhinitis Ciclesonide PAR |
|
Rhinitis Rhinitis, Allergic, Perennial Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Histamine Antagonists Azelastine Histamine H1 Antagonists Ciclesonide Histamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Histamine H1 Antagonists, Non-Sedating Lipoxygenase Inhibitors Enzyme Inhibitors Anti-Allergic Agents Therapeutic Uses Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |