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A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
This study is currently recruiting participants.
Verified by Meda Pharmaceuticals, April 2009
First Received: April 16, 2009   No Changes Posted
Sponsored by: Meda Pharmaceuticals
Information provided by: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00883168
  Purpose

The purpose of this study is to determine if the combination of two allergy medications (formulated azelastine/fluticasone product)is more effective than placebo or either component 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: Azelastine Azelastine hydrochloride Fluticasone propionate Fluticasone
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 [ 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 ]

Estimated Enrollment: 1800
Study Start Date: April 2009
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (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 mg
3: Active Comparator
fluticasone propionate
Drug: fluticasone propionate
fluticasone propionate 200 mcg
4: Experimental
azelastine hydrochloride/fluticasone propionate formulated product
Drug: azelastine hydrochloride/fluticasone propionate formulated product
azelastine hydrochloride 548 mcg/fluticasone propionate 200 mcg

  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 subjects 12 years of age and older
  2. Provide written informed consent/pediatric assent. If the subject is a minor, a parent or legal guardian must give written informed consent
  3. 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
  4. 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
  5. Randomization Visit: For the 3 days prior to Randomization and on the morning of Randomization, the sum of the 7 consecutive reflective AM and PM TNSS assessments shall be equal to or greater than 56, with a nasal congestion score equal to or greater than 14
  6. Randomization Visit: Have an instantaneous TNSS score of at least 8 and a congestion score of at least 2 at time point zero, just prior to beginning the onset of action assessment
  7. Have taken at least 10 doses of the lead-in medication
  8. Willing and able to comply with the study requirements
  9. At least a 2-year history of SAR during the current allergy season
  10. The presence of IgE-mediated hypersensitivity to a prevailing, individual, seasonal 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 an average of 5X5 mm larger than the negative control and a positive wheal of at least an average of 5X5 mm to histamine.
  11. 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.
  12. 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 vial is used does not preclude participation.

  13. Subjects 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 superficial and moderate nasal mucosal erosion, nasal mucosal ulceration, or nasal septum perforation (Grade 1b - 4) at either the screening visit or randomization visit will disqualify the subject from the study.
  2. Other nasal disease(s) likely to affect deposition of intranasal medication, 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 pollen area during the study period
  6. The use of any investigational drug within 30 days prior to Visit 1. No investigational products are permitted for use during the conduct of this study
  7. Presence of any hypersensitivity to drugs similar to azelastine hydrochloride or fluticasone propionate
  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* see section 6.1.1
  10. Respiratory Tract Infections within 14 days prior to Visit 1
  11. Respiratory Tract Infections requiring antibiotic treatment 14 days prior to Visit 1
  12. Asthma (with the exception of intermittent asthma). Subjects with intermittent asthma who only require short-acting inhaled bronchodilators (not more often than twice per week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment
  13. Significant pulmonary disease including COPD
  14. Clinically significant arrhythmia or symptomatic cardiac conditions
  15. A known history of alcohol or drug abuse within the last 2 years
  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; that might significantly affect the subject's ability to complete this trial; or their safety in this trial.
  17. Patients with a history of glaucoma
  18. 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
  19. Employees of the research center or private practice and their family members are excluded
  20. In order to ensure an adequate safety database, sites should make every effort to ensure no more than 50% of their subjects have participated in protocol MP4001, MP4002 or MP4004
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883168

Contacts
Contact: Carrie L D'Andrea, MS 732-564-2538

  Show 45 Study Locations
Sponsors and Collaborators
Meda Pharmaceuticals
Investigators
Study Director: Lewis M Fredane, MD Meda Pharmaceuticals
  More Information

No publications provided

Responsible Party: Meda Pharmaceuticals ( Harry Sacks, MD Vice president, medical Affairs )
Study ID Numbers: MP4006
Study First Received: April 16, 2009
Last Updated: April 16, 2009
ClinicalTrials.gov Identifier: NCT00883168     History of Changes
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Anti-Inflammatory Agents
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
Fluticasone
Dermatologic Agents
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

ClinicalTrials.gov processed this record on May 06, 2009