A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
NCT ID: NCT00660517
Last Updated: 2012-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
607 participants
INTERVENTIONAL
2007-12-31
2008-04-30
Brief Summary
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Detailed Description
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Efficacy will be assessed by the change from baseline in the subject-reported 12-hour reflective Total Nasal Symptom Score (TNSS), consisting of the sum of the scores of sneezing, nasal congestion, runny nose, and nasal itching. On Days -7 through 14, subjects will rate the TNSS symptoms, the TOSS symptoms of itchy eyes, watery eyes and eye redness, and the symptom of postnasal drip twice daily (AM and PM) in a diary prior to the dose of study medication. Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be 24 for the TNSS and 18 for the TOSS. The 12-hour reflective TNSS, the instantaneous TNSS, the 12-hour reflective score for postnasal drip, the 12-hour reflective TOSS, and the instantaneous TOSS will be calculated based on these scores. Additional secondary efficacy variables will include reflective and individual nasal and ocular symptom scores and change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
Subjects ≥ 18 years of age will complete the adult RQLQ on Day 1 (prior to dosing) and Day 14. Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the 2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at time of early termination) for an end-of-study evaluation. Safety and tolerability assessments will be made on Days 7 and 14. Tolerability will be evaluated by subject reported adverse events (AEs), nasal examinations, and vital signs assessments.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MP29-02
azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray
MP29-02
azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray one spray per nostril twice a day
azelastine Hcl 548 mcg
azelastine Hcl 548 mcg nasal spray
azelastine Hcl
azelastine Hcl nasal spray one spray per nostril two times a day
fluticasone propionate 200 mcg
fluticasone propionate 200 mcg nasal spray
fluticasone propionate
fluticasone propionate 200 mcg nasal spray one spray per nostril two times a day
placebo
placebo nasal spray
placebo
placebo nasal spray one spray per nostril two times a day
Interventions
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MP29-02
azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray one spray per nostril twice a day
azelastine Hcl
azelastine Hcl nasal spray one spray per nostril two times a day
fluticasone propionate
fluticasone propionate 200 mcg nasal spray one spray per nostril two times a day
placebo
placebo nasal spray one spray per nostril two times a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be in generally good health
* Must meet minimum symptom requirements, as specified in the protocol.
* Must be willing and able to provide informed consent and to participate in all study procedures
* Positive skin test to a prevalent Texas Mountain Cedar allergen
Exclusion Criteria
* Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
* Nasal surgery or sinus surgery within the previous year.
* Chronic sinusitis - more than 3 episodes per year
* Planned travel outside of the study area during the study period
* The use of any investigational drug within 30 days prior to Day screening. No investigational products are permitted for use during the conduct of this study
* Presence of any hypersensitivity to drugs similar to azelastine hydrochloride or fluticasone propionate
* Women who are pregnant or nursing
* Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception\* see section 6.1.1
* Respiratory Tract Infections within 14 days prior to Day screening
* Respiratory Tract Infections requiring antibiotic treatment 14 days prior to screening
* Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not more often than twice per week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment
* Significant pulmonary disease including COPD
* Clinically significant arrhythmia or symptomatic cardiac conditions
* A known history of alcohol or drug abuse within the last 2 years
* Existence of any surgical or medical condition or physical or laboratory findings, which in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug; that might significantly affect the subject's ability to complete this trial; or their safety in this trial.
* Clinically relevant abnormal physical findings within 1 week of randomization which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures
12 Years
ALL
No
Sponsors
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Meda Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Lewis M Fredane, MD
Role: STUDY_DIRECTOR
Meda Pharmaceuticals
Locations
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Allergy and Asthma Associates
Austin, Texas, United States
Central Texas Research
New Braunfels, Texas, United States
Southwest Allergy and Asthma Center, P.A.
San Antonio, Texas, United States
Sylvana Research Associates
San Antonio, Texas, United States
Allergy, Asthma Research Center
San Antonio, Texas, United States
Allergy and Asthma Care
Waco, Texas, United States
Allergy and Asthma Center
Waco, Texas, United States
Countries
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References
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Hampel FC, Ratner PH, Van Bavel J, Amar NJ, Daftary P, Wheeler W, Sacks H. Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device. Ann Allergy Asthma Immunol. 2010 Aug;105(2):168-73. doi: 10.1016/j.anai.2010.06.008.
Other Identifiers
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MP4001
Identifier Type: -
Identifier Source: org_study_id