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

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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)

Official Title

Randomised, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis

Conditions

  • Seasonal Allergic Rhinitis

Study Type

Interventional

Study Design

Treatment, Randomised, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

  • change from baseline in 12-hour reflective total nasal symptom score

Secondary Outcome Measures: 

  • Change from baseline in 12 hour instantaneous total nasal symptom score 
  • Onset of action assessment
  • Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
  • Nasal examinations

Study Start

March, 2008

Eligibility & Criteria

Official Title

Randomised, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis

Conditions

  • Seasonal Allergic Rhinitis

Study Type

Interventional

Study Design

Treatment, Randomised, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

  • change from baseline in 12-hour reflective total nasal symptom score

Secondary Outcome Measures: 

  • Change from baseline in 12 hour instantaneous total nasal symptom score 
  • Onset of action assessment
  • Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
  • Nasal examinations

Study Start

March, 2008

Eligibility & Criteria

Eligibility

  • Ages Eligible for Study: 12 Years and older
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers: No

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 all study procedures
  • Positive skin test to a prevalent spring allergen

Exclusion criteria

  • On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
  • Nasal disease likely to affect the deposition of the medication or evaluation, such as sinus infection, nasal polyps or severe deviated septum
  • Nasal or sinus surgery within the previous 6 months
  • Chronic sinus infection (more than 3 per year)
  • Planned travel outside the study area during the study period
  • Use of any investigational drug within 30 days of the first visit
  • Hypersensitivity (bad reaction) to azelastine hydrchloride nasal spray (Astelin), or fluticasone propionate nasal spray (Flonase)
  • Women who are not using an acceptable method of birth control
  • Women who are pregnant or nursing
  • Upper respiratory tract infection such as common cold, flu, sinus infection within 2 weeks of first study visit
  • Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with the investigator
  • Irregular heartbeat or other symptomatic heart conditions
  • History of alcohol or drug abuse
  • History of glaucoma
  • Use of medications that could affect the study results

Total Enrolment

780

Contact Details

Location Details

Location: Allergy, Asthma and Immunology Associates
              7514 East Monterey Way, Suite #1 
              Scottsdale, Arizona 85251

Contact Details

POC: Lewis M. Fredane, MD
Phone No.: +1 (480) 949-7377
Fax No.: +1 (480) 949-8339
Email: contact@allergyasthmaaz.com
Website: www.allergyasthmaaz.com

Total Enrolment

780

Contact Details

Location Details

Location: Allergy, Asthma and Immunology Associates
              7514 East Monterey Way, Suite #1 
              Scottsdale, Arizona 85251

Contact Details

POC: Lewis M. Fredane, MD
Phone No.: +1 (480) 949-7377
Fax No.: +1 (480) 949-8339
Email: contact@allergyasthmaaz.com
Website: www.allergyasthmaaz.com

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Dates

Posted On: 1 January, 2013
Modified On: 16 September, 2014

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