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

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ClinicalTrials.gov Identifier: NCT00660829
Recruitment Status : Completed
First Posted : April 17, 2008
Results First Posted : January 28, 2010
Last Update Posted : April 13, 2015
Sponsor:
Information provided by (Responsible Party):
Meda Pharmaceuticals

April 14, 2008
April 17, 2008
September 30, 2009
January 28, 2010
April 13, 2015
December 2007
February 2008   (Final data collection date for primary outcome measure)
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) (AM and PM Combined)at 14 Days [ Time Frame: baseline and 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
Change from baseline in 12-hour reflective total nasal symptom score [ Time Frame: 14 days ]
Complete list of historical versions of study NCT00660829 on ClinicalTrials.gov Archive Site
  • Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (AM) for the Entire 14-day Study Period Compared to Placebo. [ Time Frame: baseline and 14 days ]
    End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous (tNSS) for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous (tNSS) consists of runny nose, itchy nose, nasal congestion, and sneezing. 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 square means 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 a covariate.
  • Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (AM and PM Combined) at 14 Days [ Time Frame: baseline and 14-days ]
    instantaneous (subjects rate how they feel "right now") 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
  • 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) [ Time Frame: baseline and 14-days ]
    Reflective secondary complex symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS 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
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: baseline and 14 Days ]
    A 28-item RQLQ was completed on Day 1 and Day 14 or Early termination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Scores for a series of subscales are not combined for a total overall score, rather domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.
  • Change From Baseline on Direct Visual Nasal Exams at 14 Days [ Time Frame: baseline and 14 Days ]
    Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation
  • Change from baseline in 12 hour instantaneous total nasal symptom score [ Time Frame: 14-day ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: 14 Days ]
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 in Subjects With Seasonal Allergic Rhinitis
The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Seasonal Allergic Rhinitis
  • Drug: Placebo
    Placebo
  • Drug: 0.15% Azelastine Hydrochloride
    0.15% Azelastine Hydrochloride 822 mcg
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: 2
    0.15% Azelastine Hydrochloride
    Intervention: Drug: 0.15% Azelastine Hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
536
Same as current
April 2008
February 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00660829
MP440
No
Not Provided
Not Provided
Meda Pharmaceuticals
Meda Pharmaceuticals
Not Provided
Study Director: Lewis M Fredane, MD Meda Pharmaceuticals
Meda Pharmaceuticals
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP