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Two Formulations and Concentrations of Epinastine Nasal Spray Versus Azelastine Nasal Solution for Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT01382654
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : November 2, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:

The objectives of this study were to:

  • Examine the tolerability of two formulations and two dose concentrations of epinastine.
  • Select formulation(s) of epinastine for future studies by evaluating the individual sensory attribute scores of the Nasal Spray Evaluation Questionnaire (NSEQ) collected after each study drug administration and the subject preference ranking assessed at the completion of the study.
  • Compare the preference of two formulations and two dose concentrations of epinastine compared to azelastine following a single dose of each in a randomized, double-blind, two-cohort, three-period crossover design.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: epinastine 0.1% Drug: epinastine 0.1% with taste masking agent Drug: epinastine 0.2% Drug: epinastine 0.2% with taste masking agent Drug: azelastine 0.1% Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: epinastine 0.1%
nasal spray 2 sprays to each nostril for a total of 3 doses
Drug: epinastine 0.1%
nasal spray 2 sprays to each nostril for a total of 3 doses

Experimental: epinastine 0.1% with taste masking agent
nasal spray 2 sprays to each nostril for a total of 3 doses
Drug: epinastine 0.1% with taste masking agent
nasal spray 2 sprays to each nostril for a total for a 3 doses

Experimental: epinastine 0.2%
nasal spray 2 sprays to each nostril for a total of 3 doses
Drug: epinastine 0.2%
nasal spray 2 sprays to each nostril for a total of 3 doses

Experimental: epinastine 0.2% with taste masking agent
nasal spray 2 sprays to each nostril for a total of 3 doses
Drug: epinastine 0.2% with taste masking agent
nasal spray 2 sprays to each nostril for a total of 3 doses

Active Comparator: azelastine 0.1%
nasal spray 2 sprays in each nostril for a total of 3 doses
Drug: azelastine 0.1%
nasal spray 2 sprays to each nostril for a total of 3 doses




Primary Outcome Measures :
  1. Overall preference rank at the completion of the study using the Overall Nasal Spray Evaluation Questionnaire (NSEQ) [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. Scores from each individual response from the NSEQ of all administered formulations (two formulations and two concentrations of epinastine and azelastine). [ Time Frame: 2 days ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • between ages 18-70
  • history of SAR or PAR for 1 year
  • mild symptoms

Exclusion Criteria:

  • asthma or RAD
  • respiratory tract infection within 14 days prior to screening
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01382654    
Other Study ID Numbers: 033-102
033-102 ( Other Identifier: Inspire Pharmaceuticals )
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: November 2, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Azelastine
Epinastine
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Lipoxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents