Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis
This study has been completed.
Sponsor:
Alcon Research
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00772304
First received: October 13, 2008
Last updated: February 23, 2010
Last verified: February 2010
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Purpose
To compare patient perceptions of the sensory attributes, including taste and aftertaste, of Olopatadine relative to azelastine when administered as a single dose in patients with allergic rhinitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Rhinitis |
Drug: Olopatadine 0.6% / Azelastine 137 mcg |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
Resource links provided by NLM:
MedlinePlus related topics:
Taste and Smell Disorders
Drug Information available for:
Azelastine
Azelastine hydrochloride
Olopatadine
Olopatadine hydrochloride
U.S. FDA Resources
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Product Preference Questionnaire for Immediate Taste [ Time Frame: 5 min post-dose ] [ Designated as safety issue: No ]Using a set of coded responses, subjects evaluated product preference in regards to immediate taste
Secondary Outcome Measures:
- Taste and Aftertaste of Medication [ Time Frame: 5 min, 45 min. ] [ Designated as safety issue: No ]
| Enrollment: | 102 |
| Study Start Date: | October 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Olopatadine 0.6% / Azelastine 137 mcg
|
Drug: Olopatadine 0.6% / Azelastine 137 mcg
single dose; 2 sprays per nostril
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Must have a history (at least 2 yrs) of allergic rhinitis and be symptomatic at time of enrollment
- 18 yrs of age or older
- Read and sign informed consent
- Females of childbearing potential may participate if: are non-breast feeding, have negative urine pregnancy test at visit 1, agree to take urine pregnancy test upon exiting study, do not intend to become pregnant during the study, are using adequate methods of birth control.
Exclusion Criteria:
- History of intolerance or hypersensitivity to any component of the study medications, including benzalkonium chloride.
- Any disease or systemic disorder that may complicate or interfere with investigation or evaluation of the study medications (including but not limited to): Rhinitis medicamentosa, large obstructive nasal polyps, history (w/in last 3 months) of nasal septic ulcers, nasal surgery or nasal trauma, history or evidence of nasolacrimal drainage system malfunction, history (w/in 30 days) or evidence of sinusitis or upper or lower respiratory infection.
- Impairment of sense of tast or smell (self reported)
- Asthma, except for mild, intermittent asthma (nat'l Asthma guidelines)
- Congestion, that in the opinion of the investigator, that would interfere with successful nasal drug administration/absorption
- Patients w/a severe impairment of nasal breathing
- Anatomic abnormalities of as identified by nasal examination
- History of or current severe or uncontrolled cardiovascular, hepatic, renal and/or other disease/illness that could interfere w/study.
- History of (w/in past 12 months) or ongoing clinically relevant electrolyte abnormalities.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Michael Edwards, PhD\Global Scientific Market Affairs, Alcon Research |
| ClinicalTrials.gov Identifier: | NCT00772304 History of Changes |
| Other Study ID Numbers: | SMA-08-21 |
| Study First Received: | October 13, 2008 |
| Results First Received: | December 3, 2009 |
| Last Updated: | February 23, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Alcon Research:
|
rhinitis |
Additional relevant MeSH terms:
|
Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Azelastine Olopatadine Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
Lipoxygenase Inhibitors Enzyme Inhibitors Anti-Allergic Agents Therapeutic Uses Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Anti-Inflammatory Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 23, 2013