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

This study has been completed.
Sponsor:
Information provided by:
Meda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00660829
First received: April 14, 2008
Last updated: February 19, 2010
Last verified: January 2010
  Purpose

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


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: Placebo
Drug: 0.15% Azelastine Hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 in Subjects With Seasonal Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by Meda Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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, treatemnt by-study day interaction, and basline as co-variate



Secondary Outcome Measures:
  • Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (AM) for the Entire 14-day Study Period Compared to Placebo. [ Time Frame: basline and 14 days ] [ Designated as safety issue: No ]

    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.

    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 ] [ Designated as safety issue: No ]

    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, treatemnt by-study day interaction, and basline 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 ] [ Designated as safety issue: No ]

    Reflective secondary complex symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) 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, treatemnt by-study day interaction, and basline as co-variate


  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: baseline and 14 Days ] [ Designated as safety issue: No ]

    A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. 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 subsclaes 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 ] [ Designated as safety issue: Yes ]
    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 irratation 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


Enrollment: 536
Study Start Date: December 2007
Study Completion Date: April 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: Placebo
Placebo
Active Comparator: 2
0.15% Azelastine Hydrochloride
Drug: 0.15% Azelastine Hydrochloride
0.15% Azelastine Hydrochloride 822 mcg

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660829

Locations
United States, Texas
Allergy and Asthma Center of Austin
Austin, Texas, United States, 78759
Allergy and Asthma Associates
Austin, Texas, United States, 78731
Central Texas Research
New Braunfels, Texas, United States, 78130
Sylvana Research Associates
San Antonio, Texas, United States, 78229
Biogenics Research Institute
San Antonio, Texas, United States, 78229
Allergy and Asthma Center
Waco, Texas, United States, 76712
Sponsors and Collaborators
Meda Pharmaceuticals
Investigators
Study Director: Lewis M Fredane, MD Meda Pharmaceuticals
  More Information

No publications provided

Responsible Party: Harry Sacks, MD Vice President, Medical and Scientific Affairs
ClinicalTrials.gov Identifier: NCT00660829     History of Changes
Other Study ID Numbers: MP440
Study First Received: April 14, 2008
Results First Received: September 30, 2009
Last Updated: February 19, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Azelastine
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Lipoxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on October 19, 2014