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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00719862
Recruitment Status : Completed
First Posted : July 22, 2008
Results First Posted : January 28, 2010
Last Update Posted : February 2, 2010
Information provided by:
Meda Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Placebo nasal spray Drug: 0.15% azelastine hydrochloride Nasal Spray Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 481 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Nasal Spray
0mg Placebo Nasal Spray
Drug: Placebo nasal spray
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%

Primary Outcome Measures :
  1. Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined)at 14 Days [ Time Frame: baseline and 14 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 Days [ Time Frame: baseline and 14-days ]
  3. 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 ]
  4. Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days [ Time Frame: baseline and 14 Days ]
  5. Change From Baseline on Direct Visual Nasal Exams at 14 Days [ Time Frame: baseline and 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00719862

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Sponsors and Collaborators
Meda Pharmaceuticals
Study Director: Lewis M Fredane, MD Meda Pharmaceuticals

Responsible Party: Harry Sacks, MD Vice President, Medical and Scientific Affairs Identifier: NCT00719862     History of Changes
Other Study ID Numbers: MP439
First Posted: July 22, 2008    Key Record Dates
Results First Posted: January 28, 2010
Last Update Posted: February 2, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
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