Clinical trial NCT00824473: 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: 2009-01-16
Enrollment: 506
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:

1. Male and female subjects 12 years of age and older
2. Provide written informed consent/pediatric assent. If the subject is a minor, a parent or legal guardian must give written informed consent
3. Screening Visit: Have a 12-hour reflective TNSS of at least 8 out of a possible 12 and a congestion score of 2 or 3 on visit 1
4. Randomization Visit: Have a 12-hour reflective TNSS (AM or PM) of at least 8 on 3 separate symptom assessments (one of which was within 2 days of visit 2, and can include the morning of visit 2) during the Lead-in Period. In addition, an AM or PM 12-hour reflective nasal congestion score of 2 or 3 must have been recorded on 3 separate symptom assessments (one of which was within 2 days of visit 2, and can include the morning of visit 2)
5. Willing and able to comply with the study requirements
6. At least a 2-year history of SAR during Texas Mountain Cedar season
7. The presence of IgE-mediated hypersensitivity to Texas Mountain Cedar, confirmed by a positive response to skin prick within the last year. A positive response is defined as a wheal diameter of at least 3 mm larger than the negative control.
8. General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer. When in doubt, the investigator should confer with the sponsor's medical monitor or designee to determine eligibility for the study.
9. Subjects receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections do not preclude participation).Dose reduction when a new bottle is used does not preclude participation.
10. Subjects currently receiving sublingual immunotherapy are excluded. A 6-month washout period is required following the last dose of sublingual immunotherapy.

Exclusion Criteria:

1. On Focused Nasal Examination, the presence of any superficial and moderate nasal mucosal erosion, nasal mucosal ulceration, or nasal septum perforation (Grade 1b-4) at either screening visit or randomization visit will disqualify the subjects from the study.
2. Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or clinically significant nasal structural abnormalities.
3. Nasal surgery or sinus surgery within the previous year.
4. Chronic sinusitis - more than 3 episodes per year
5. Planned travel outside of the study area during the study period
6. The use of any investigational drug within 30 days prior to visit 1. No investigational products are permitted for use during the conduct of this study
7. Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
8. Women who are pregnant or nursing
9. Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception
10. Respiratory Tract Infections within 14 days prior to visit 1
11. Respiratory Tract Infections requiring antibiotic treatment 14 days prior to visit 1
12. Asthma (with the exception of 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
13. Significant pulmonary disease including COPD
14. Clinically significant arrhythmia or symptomatic cardiac conditions
15. A known history of alcohol or drug abuse within the last 2 years
16. 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.
17. 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
18. Participation in MedPointe Protocols MP439 or MP440.
19. Employees of the research center / private practice and their family are excluded

Primary outcomes:
measure: Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)at 14 Days
timeFrame: baseline and 14 days
Secondary outcomes:
measure: Mean Change From Baseline in Instantaneous Total Nasal Symptom Sscore (AM) for the Entire 14-day Study Period Compared to Placebo
timeFrame: baseline to 14 Days
measure: Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)
timeFrame: baseline to 14 Days
measure: Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)
timeFrame: baseline to14 Days
measure: Change From Baseline to Visit 4 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older
timeFrame: 14 Days
measure: Change From Baseline on Direct Visual Nasal Exams to 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 Health Research
state: Texas
city: San Antonio
country: United States
facility: Southwest Allergy and Asthma Center, P.A.
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: San Antonio
country: United States
facility: Allergy, Asthma Research Center
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:
citation: Howland WC, Amar NJ, Wheeler W, Sacks H. Efficacy and safety of azelastine 0.15% nasal spray administered once daily in patients with allergy to Texas mountain cedar pollen. Int Forum Allergy Rhinol. 2011 Jul-Aug;1(4):275-9. doi: 10.1002/alr.20065. Epub 2011 May 9.