Clinical trial NCT00660829: A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
Official title: Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 in Subjects With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Meda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-04-17
Enrollment: 536
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone.


Eligibility criteria: Inclusion Criteria:

* Male and Female patients 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis.
* 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:

* On Focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation at either the screening visit or randomization visit will disqualify the subject from the study.
* 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 Screening. No investigational products are permitted for use during the conduct of this study
* Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
* Women who are pregnant or nursing
* Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception
* Respiratory Tract Infections within 14 days prior to 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 which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures

Primary outcomes:
measure: Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) (AM and PM Combined)at 14 Days
timeFrame: baseline and 14 days
Secondary outcomes:
measure: Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (AM) for the Entire 14-day Study Period Compared to Placebo.
timeFrame: baseline and 14 days
measure: Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (AM and PM Combined) at 14 Days
timeFrame: baseline and 14-days
measure: Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score (SSCS) for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)
timeFrame: baseline and 14-days
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
timeFrame: baseline and 14 Days
measure: Change From Baseline on Direct Visual Nasal Exams at 14 Days
timeFrame: baseline and 14 Days
Other outcomes:
Locations:
city: Austin
country: United States
facility: Allergy and Asthma Associates
state: Texas
city: Austin
country: United States
facility: Allergy and Asthma Center of Austin
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Research
state: Texas
city: San Antonio
country: United States
facility: Biogenics Research Institute
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: Waco
country: United States
facility: Allergy and Asthma Center
state: Texas
Study officials:
affiliation: Meda Pharmaceuticals
name: Lewis M Fredane, MD
role: STUDY_DIRECTOR
References: