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

This study has been completed.
Sponsor:
Information provided by:
Meda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00712920
First received: July 8, 2008
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to determine if two allergy medications are more effective than placebo.


Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: 0.15% azelastine hydrochloride
Drug: 0.1% azelastine hydrochloride
Drug: Placebo
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 and MP03-33 in Patients With Perennial 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 (AM and PM Combined) at 28 Days. [ Time Frame: baseline and 28 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 square means (LS Mean) 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 basline as a covariate.



Secondary Outcome Measures:
  • Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days [ Time Frame: baseline and 28 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.

  • Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days [ Time Frame: baseline and 28 days ] [ Designated as safety issue: No ]
    Reflective secondary symptom complex 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.

  • Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days [ Time Frame: baseline and 28 Days ] [ Designated as safety issue: No ]
    A 28-item RQLQ was completed on Day 1 and Day 28 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. 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 and 28 Days [ Time Frame: baseline and 28 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: 581
Study Start Date: January 2007
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: Placebo
Placebo
Experimental: 2
0.15% azelastine hydrochloride 1644 mcg/2 sprays per nostril 2 times a day for 4 weeks
Drug: 0.15% azelastine hydrochloride
0.15% azelastine hydrochloride 1644 mcg
Experimental: 3
0.1% azelastine hydrochloride 1096 mcg/2 sprays per nostril 2 times a day for 4 weeks
Drug: 0.1% azelastine hydrochloride
0.1% azelastine hydrochloride 1096 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
  • Must be in generally good health
  • Must meet minimum symptom requirements, as specified in protocol
  • Must be willing and able to provide informed consent and participate in all study procedures
  • 2-year history of PAR
  • Positive skin test to cockroach, dust mite, mold or cat/dog dander

Exclusion Criteria:

  • On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit
  • Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities
  • Nasal surgery or sinus surgery within the previous year
  • The use of any investigational drug within 30 days
  • Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose
  • Women who are pregnant or nursing
  • Women of child-bearing potential who are not abstinent and not practicing a medically acceptable method of contraception
  • Respiratory tract infection within 2 weeks of screening
  • Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of screening
  • Patients with asthma with the exception of mild, intermittent
  • Significant pulmonary disease including COPD
  • Patients with arrhythmia
  • Patients with a known history of alcohol or drug abuse
  • Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor may significantly alter the absorption, distribution, metabolism or excretion of study drug.
  • Clinically relevant abnormal physical findings within one week of randomization
  • Overnight abscences from home for more than 3 nights
  • Employees of the research center or private practice and family members are excluded
  • Patients who received prohibited medications within specified timepoints in protocol.
  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: NCT00712920

  Show 43 Study Locations
Sponsors and Collaborators
Meda Pharmaceuticals
  More Information

No publications provided

Responsible Party: Harry Sacks, MD Vice President, Medical and Scientific Affairs, Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00712920     History of Changes
Other Study ID Numbers: MP434
Study First Received: July 8, 2008
Results First Received: September 30, 2009
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 22, 2014