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A Study to Evaluate the Safety and Efficacy of Two Nasal Sprays to Treat Seasonal Allergies
This study has been completed.
First Received: July 21, 2008   Last Updated: May 19, 2009   History of Changes
Sponsored by: Meda Pharmaceuticals
Information provided by: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00720278
  Purpose

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


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: 0.15% azelastine hydrochloride 1644 mcg daily
Drug: 0.1% azelastine hydrochloride 1096 mcg daily
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 and MP03-33 Compared to Placebo 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 for the entire 14-day study period compared to placebo [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in instantaneous total nasal symptom score for the entire 14-day study period compared to placebo [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
  • Change from baseline in 12-hour reflective individual symptom scores for the entire 14-day study period compared to placebo [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Onset of action (change from baseline in instantaneous total nasal symptom score compared to placebo over the 4-hour period following initial administration of study drugs) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Daily scores - Daily change from baseline in 12-hour reflective and instantaneous total nasal symptom score compared to placebo for the 14-day study period [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Change from baseline in the 12-hour reflective secondary symptom complex score for the entire 14-day study period compared to placebo [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Change from baseline in the 12-hour reflective secondary symptom complex score individual symptom scores for the entire 14-day study period compared to placebo [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Change from baseline to Day 14 in the rhinoconjunctivitis quality of life questionnaire (RQLQ) compared to placebo in patients 18 years of age and older [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Change from baseline on direct visual nasal exams [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 526
Study Start Date: August 2007
Study Completion Date: November 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator
Placebo
Drug: Placebo
2: Experimental
0.1% azelastine hydrochloride
Drug: 0.1% azelastine hydrochloride 1096 mcg daily
3: Experimental
0.15% azelastine hydrochloride
Drug: 0.15% azelastine hydrochloride 1644 mcg daily

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients 12 years of age and older
  2. Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
  3. Screening Visit: Have a 12-hour reflective TNSS of at least 8 out of a possible 12 and a congestion score of 2 or 3 on Day -7
  4. Randomization Visit: Have a 12-hour reflective TNSS (AM or PM) of at least 8 on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) during the Lead-in Period. In addition, an AM or PM 12-hour reflective nasal congestion score of 2 or 3 must have been recorded on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day

    1)

  5. Randomization Visit: An instantaneous TNSS of ≥ 8 before beginning the onset of action assessment on Day

    1

  6. Must have taken at least 10 doses of study medication during the lead-in period
  7. Willing and able to comply with the study requirements
  8. At least a 2-year history of SAR
  9. The presence of IgE-mediated hypersensitivity to ragweed antigen or other local fall allergens, confirmed by a positive response to either skin prick within the last year. A positive response is defined as a wheal diameter of at least 3 mm larger than the negative control for the skin prick test.
  10. General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer. When in doubt, the investigator should confer with the sponsor's medical monitor or designee to determine eligibility for the study.
  11. Patients receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections does not preclude participation). Patients currently receiving sublingual immunotherapy are excluded. A 6-month washout period is required following the last dose of sublingual immunotherapy.

Exclusion Criteria:

  1. 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 patient from the study.
  2. Other nasal disease(s) likely such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
  3. Nasal surgery or sinus surgery within the previous year.
  4. Chronic sinusitis - more than 3 episodes per year
  5. Planned travel outside of the study area during the study period
  6. The use of any investigational drug within 30 days prior to Day -7. No investigational products are permitted for use during the conduct of this study
  7. Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
  8. Women who are pregnant or nursing
  9. Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception
  10. Respiratory Tract Infections within 14 days prior to Day -7
  11. Respiratory Tract Infections requiring oral antibiotic within 14 days of Day -7
  12. Asthma (with the exception of mild, intermittent asthma). Patients with mild, intermittent asthma who only require short-acting inhaled bronchodilators are eligible for enrollment.
  13. Significant pulmonary disease including COPD
  14. Clinically significant arrhythmia or with symptomatic cardiac conditions
  15. A known history of alcohol or drug abuse
  16. 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 or that might significantly affect the patient's ability to complete this trial.
  17. Clinically relevant abnormal physical findings within 1 week of randomization which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures
  18. Participation in MedPointe Protocols MP433, MP434, MP435, or MP436.
  19. Employees of the research center or private practice and their family members are excluded
  20. Patients who received prohibited medications within specified timepoints in the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720278

  Show 29 Study Locations
Sponsors and Collaborators
Meda Pharmaceuticals
  More Information

No publications provided

Responsible Party: Med Pharmaceuticals ( Harry Sacks, MD Vice President, Medical and Scientific Affairs )
Study ID Numbers: MP438
Study First Received: July 21, 2008
Last Updated: May 19, 2009
ClinicalTrials.gov Identifier: NCT00720278     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Neurotransmitter Agents
Otorhinolaryngologic Diseases
Anti-Asthmatic Agents
Rhinitis
Anti-Allergic Agents
Azelastine
Lipoxygenase Inhibitors
Histamine
Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Histamine Antagonists
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Histamine H1 Antagonists
Histamine phosphate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

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

ClinicalTrials.gov processed this record on September 09, 2009