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A Study Evaluating the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
This study has been completed.
Sponsored by: Meda Pharmaceuticals
Information provided by: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00740792
  Purpose

The purpose of this study is to determine if two allergy medications (formulated azelastine and fluticasone product) are more effective than placebo or either medication alone (azelastine or fluticasone)


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: Placebo
Drug: azelastine hydrochloride
Drug: fluticasone propionate
Drug: azelastine hydrochloride/fluticasone propionate formulated product
Phase III

MedlinePlus related topics: Allergy Hay Fever
Drug Information available for: Fluticasone Fluticasone propionate Azelastine Azelastine hydrochloride
U.S. FDA Resources
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 Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis.

Further study details as provided by Meda Pharmaceuticals:

Primary Outcome Measures:
  • change from baseline in 12 hour reflective total nasal symptom score [ Time Frame: 14-days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in 12 hour instantaneous total nasal symptom score [ Time Frame: 14-days ] [ Designated as safety issue: No ]
  • Onset of action assessment [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
  • Nasal Examinations [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 779
Study Start Date: August 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator
Placebo
Drug: Placebo
Placebo
2: Active Comparator
azelastine hydrochloride
Drug: azelastine hydrochloride
azelastine hydrochloride 548 mcg
3: Active Comparator
fluticasone propionate
Drug: fluticasone propionate
fluticasone propionate 200mcg
4: Experimental
azelastine hydrochloride/fluticasone propionate formulated product
Drug: azelastine hydrochloride/fluticasone propionate formulated product
azelastine hydrochloride 548mcg/fluticasone propionate 200mcg

  Eligibility

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

Inclusion Criteria:

  • Male and female subjects 12 years of age and older
  • Provide written informed consent/pediatric assent. If the subject is a minor, parent or legal guardian must give written informed consent
  • Subjects must have moderate-to-severe rhinitis, defined as rhinitis with one or more of the following being present:

    1. Sleep disturbance
    2. Impairment of daily activities, leisure and/or sport
    3. Impairment of school or work
    4. Troublesome symptoms
  • 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 Visit 1
  • 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.
  • Randomization Visit: Have 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) Randomization Visit: Have an instantaneous TNSS score of 8 or more at time point zero, just prior to beginning the onset of action assessment
  • Have taken at least 10 doses of the lead-in medication
  • Willing and able to comply with the study requirementsAt least a 2-year history of SAR during Fall allergy season
  • The presence of IgE-mediated hypersensitivity to a local Fall pollen, confirmed by a positive response to 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.
  • 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.
  • Subjects 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 do not preclude participation).
  • Dose reduction when a new bottle is used does not preclude participation. Subjects currently receiving sublingual immunotherapy are excluded. A 6-month washout period is required following the last dose of sublingual immunotherapy.

Exclusion Criteria:

  • On Focused Nasal Examination, the presence of any superficial and moderate nasal mucosal erosion, nasal mucosal ulceration, or nasal septum 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 pollen area during the study period
  • The use of any investigational drug within 30 days prior to Day -7.
  • Presence of any hypersensitivity to drugs similar to azelastine hydrochloride or fluticasone propionate
  • 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 Day -7
  • Respiratory Tract Infections requiring antibiotic treatment 14 days prior to Day -7
  • Asthma (with the exception of intermittent asthma).
  • 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.
  • Patients with a history of Glaucoma
  • 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
  • Employees of the research center or private practice and their family members are excluded
  • Subjects who participated in protocol MP4001 or MP4002
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740792

  Show 39 Study Locations
Sponsors and Collaborators
Meda Pharmaceuticals
Investigators
Study Director: Lewis M Fredane, MD Meda Pharmaceuticals
  More Information

Responsible Party: Meda Pharmaceuticals ( Harry Sacks, MD Vice President, Medical and Scientific Affairs )
Study ID Numbers: MP4004
Study First Received: August 22, 2008
Last Updated: November 4, 2008
ClinicalTrials.gov Identifier: NCT00740792  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Histamine phosphate
Fluticasone
Rhinitis
Azelastine
Histamine
Respiratory Hypersensitivity

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

ClinicalTrials.gov processed this record on January 16, 2009