A Study to Evaluate the Safety and Efficacy of Two Nasal Sprays to Treat Seasonal Allergies

This study has been completed.
Sponsor:
Information provided by:
Meda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00720278
First received: July 21, 2008
Last updated: February 19, 2010
Last verified: February 2010
  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 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 MP03-36 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(rTNSS)for the Entire 14-day Study Period Compared to Placebo [ Time Frame: baseline and 14 days ] [ Designated as safety issue: No ]

    rTNSS consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. (maximum 12 points per assessment.) Total possible score is 24 per day.

    Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate.



Secondary Outcome Measures:
  • Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo [ Time Frame: baseline and 14 Days ] [ Designated as safety issue: No ]

    instantaneous (subjects rate how they feel "right now") total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.

    Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.


  • Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo [ Time Frame: baseline and 14 days ] [ Designated as safety issue: No ]

    Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.

    Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.


  • 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: baseline and 14 days ] [ Designated as safety issue: No ]

    A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.

    Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.


  • Change From Baseline on Direct Visual Nasal Exams [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

    Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa.

    Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation



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
Placebo Comparator: Placebo Nasal Spray
Placebo nasal spray
Drug: Placebo
0 mcg Placebo daily
Experimental: Astepro 0.1%
0.1% azelastine hydrochloride nasal spray
Drug: 0.1% azelastine hydrochloride 1096 mcg daily
0.1% azelastine hydrochloride 1096 mcg daily
Other Name: Astepro 0.1%
Experimental: Astepro 0.15%
0.15% azelastine hydrochloride nasal spray
Drug: 0.15% azelastine hydrochloride 1644 mcg daily
0.15% azelastine hydrochloride 1644 mcg daily
Other Name: Astepro 0.15%

  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: Harry Sacks, MD Vice President, Medical and Scientific Affairs, Med Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00720278     History of Changes
Other Study ID Numbers: MP438
Study First Received: July 21, 2008
Results First Received: September 23, 2009
Last Updated: February 19, 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