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

This study has been completed.
Sponsor:
Information provided by:
Meda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00719862
First received: July 21, 2008
Last updated: January 27, 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 nasal spray
Drug: 0.15% azelastine hydrochloride Nasal Spray
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 MP03-036 in Patients 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 (AM and PM Combined)at 14 Days [ Time Frame: baseline and 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo [ Time Frame: baseline and 14 days ] [ Designated as safety issue: No ]
  • Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 Days [ Time Frame: baseline and 14-days ] [ Designated as safety issue: No ]
  • Change From Baseline in 12-hour Reflective 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 ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days [ Time Frame: baseline and 14 Days ] [ Designated as safety issue: No ]
  • Change From Baseline on Direct Visual Nasal Exams at 14 Days [ Time Frame: baseline and 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 481
Study Start Date: August 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Nasal Spray
0mg Placebo Nasal Spray
Drug: Placebo nasal spray
Placebo
Active Comparator: 0.15% azelastine hydrochloride nasal spray
0.15% azelastine hydrochloride
Drug: 0.15% azelastine hydrochloride Nasal Spray
0.15% azelastine hydrochloride 822 mcg
Other Name: astepro 0.15%

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Female
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 fall 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 a 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 the study.
  • Presence of any hypersensitivity to drugs similar to azelastine and to either sorbital or sucralose (Splenda brand sweetener)
  • Women who are pregnant or nursing
  • Women of childbearing potential who are not abstinent or not practicing medically acceptable method of contraception
  • Respiratory tract infection 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 for more often tha twice a week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment
  • Significant pulmonary disease including COPD
  • Clinically significant arrythmia 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719862

  Show 34 Study Locations
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: NCT00719862     History of Changes
Other Study ID Numbers: MP439
Study First Received: July 21, 2008
Results First Received: September 30, 2009
Last Updated: January 27, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2014