A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies

NCT00660829 | Completed Phase 3 Results

• 1 other identifier: MP440
• Study Type: interventional
• Target: 536
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) (AM and PM Combined)at 14 Days

  reflective total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day. Least Means Square was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as co-variate

  baseline and 14 days

Secondary Outcomes (5)

• Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (AM) for the Entire 14-day Study Period Compared to Placebo.

  baseline and 14 days

• Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (AM and PM Combined) at 14 Days

  baseline and 14-days

• 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)

  baseline and 14-days

• Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

  baseline and 14 Days

• Change From Baseline on Direct Visual Nasal Exams at 14 Days

  baseline and 14 Days

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo

Drug: Placebo

2

ACTIVE COMPARATOR

0.15% Azelastine Hydrochloride

Drug: 0.15% Azelastine Hydrochloride

Interventions

Placebo DRUG

Placebo

1

0.15% Azelastine Hydrochloride DRUG

0.15% Azelastine Hydrochloride 822 mcg

2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meda Pharmaceuticals: lead

Study Sites (6)

Allergy and Asthma Associates

Austin, Texas, 78731, United States

Location

Allergy and Asthma Center of Austin

Austin, Texas, 78759, United States

Location

Central Texas Research

New Braunfels, Texas, 78130, United States

Location

Biogenics Research Institute

San Antonio, Texas, 78229, United States

Location

Sylvana Research Associates

San Antonio, Texas, 78229, United States

Location

Allergy and Asthma Center

Waco, Texas, 76712, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

azelastine

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: William Wheeler, PhD
• Organization: Meda Pharmaceuticals

WWheeler@medapharma.us

732-564-2393

Study Officials

• Lewis M Fredane, MD

  Meda Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2008
• First Posted: April 17, 2008
• Study Start: December 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 13, 2015
• Results First Posted: January 28, 2010

Record last verified: 2015-04

Locations

US (6)