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

NCT00660517 | Completed Phase 3 Results

• 1 other identifier: MP4001
• Study Type: interventional
• Target: 607
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)

  change from baseline in the 12 hour reflective total nasal symptoms score(rTNSS) consisting of nasal congestion,runny nose,itchy nose and sneezing scored twice daily( AM and PM) in diary cards for the entire 14 day study period The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.

  day 1 to day14

Secondary Outcomes (2)

• Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)

  day 1 to day 14

• Change From Baseline in Adult ( Greater Than 18 Years of Age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days

  day 1 to day 14

Study Arms (4)

MP29-02

EXPERIMENTAL

azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray

Drug: MP29-02

azelastine Hcl 548 mcg

ACTIVE COMPARATOR

azelastine Hcl 548 mcg nasal spray

Drug: azelastine Hcl

fluticasone propionate 200 mcg

ACTIVE COMPARATOR

fluticasone propionate 200 mcg nasal spray

Drug: fluticasone propionate

placebo

PLACEBO COMPARATOR

placebo nasal spray

Drug: placebo

Interventions

MP29-02 DRUG

azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray one spray per nostril twice a day

MP29-02

azelastine Hcl DRUG

azelastine Hcl nasal spray one spray per nostril two times a day

Also known as: Astelin

azelastine Hcl 548 mcg

fluticasone propionate DRUG

fluticasone propionate 200 mcg nasal spray one spray per nostril two times a day

Also known as: generic Flonase

fluticasone propionate 200 mcg

placebo DRUG

placebo nasal spray one spray per nostril two times a day

placebo

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 subjects 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 (Grade 1b - 4) 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 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

Sponsors & Collaborators

• Meda Pharmaceuticals: lead

Study Sites (7)

Allergy and Asthma Associates

Austin, Texas, 78731, United States

Location

Central Texas Research

New Braunfels, Texas, 78130, United States

Location

Southwest Allergy and Asthma Center, P.A.

San Antonio, Texas, 78229, United States

Location

Sylvana Research Associates

San Antonio, Texas, 78229, United States

Location

Allergy, Asthma Research Center

San Antonio, Texas, 78258, United States

Location

Allergy and Asthma Care

Waco, Texas, 76708, United States

Location

Allergy and Asthma Center

Waco, Texas, 76712, United States

Location

Related Publications (1)

• 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.

  PMID: 20674829 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

MP29-02; azelastine; Fluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: David Ginsberg, D.O.
• Organization: Meda Pharmaceuticals

david.ginsberg@meda.us

7325642364

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: July 27, 2012
• Results First Posted: July 23, 2012

Record last verified: 2012-07

Locations

US (7)