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A Study to Evaluate the Safety and 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.
ClinicalTrials.gov Identifier: NCT00651118
Recruitment Status : Completed
First Posted : April 2, 2008
Results First Posted : September 26, 2012
Last Update Posted : September 26, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Placebo Drug: azelastine Hcl Drug: azelastineHcl / fluticasone propionate Drug: fluticasone propionate Phase 3

Detailed Description:

This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, single-blind, placebo lead-in period (Day -7 to Day 1). Subjects will be instructed to take placebo lead-in medication twice daily (1 spray per nostril), approximately every 12 hours. On Day 1, subjects who satisfy the symptom severity requirements and continue to meet all of the study inclusion/exclusion criteria will be randomized in a 1:1:1:1 ratio to receive 1 spray per nostril twice daily of MP29-02, azelastine hydrochloride, fluticasone propionate, or placebo nasal spray.

Efficacy will be assessed by the change from baseline in the subject-reported 12-hour reflective Total Nasal Symptom Score (TNSS). On Days 1 through 14, subjects will rate the instantaneous and reflective TNSS symptoms of sneezing, nasal congestion, runny nose, and nasal itching; the instantaneous and reflective total ocular symptom score (TOSS) symptoms of itchy eyes, watery eyes and eye redness; and the symptom of postnasal drip, twice daily (AM and PM) in a diary prior to the dose of study medication. Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be 24 for the TNSS and 18 for the TOSS. Additional secondary efficacy variables will include reflective individual nasal and ocular symptom scores, as well as change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).

Subjects ≥ 18 years of age will complete the RQLQ on Day 1 (prior to dosing) and Day 14. Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the 2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at time of early termination) for an end-of-study evaluation. Safety and tolerability assessments will be made on Days 7 and 14. Tolerability will be evaluated by subject-reported adverse events (AEs), nasal examinations, and vital signs assessments.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 832 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : March 2008
Primary Completion Date : June 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Active Comparator: fluticasone propionate Drug: fluticasone propionate
fluticasone propionate 200 mcg
Other Name: fluticasone
Experimental: azelastineHcl/fluticasone propionate Drug: azelastineHcl / fluticasone propionate
azelastine Hcl 548 mcg / fluticasone propionate 200 mcg
Other Name: MP29-02
Placebo Comparator: Placebo Drug: Placebo
placebo
Active Comparator: azelastine Hcl Drug: azelastine Hcl
azelastine Hcl 548 mcg
Other Name: azelastine


Outcome Measures

Primary Outcome Measures :
  1. Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS) [ Time Frame: days 1 to 14 ]

    change from baseline in 12-hour reflective(how did you feel in the last 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.

    The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative value the better the result.



Secondary Outcome Measures :
  1. Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS) [ Time Frame: day 1 to day 14 ]

    change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.

    The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative the value the better the result.


  2. Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days [ Time Frame: day 1 to day 14 ]

    adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.

    The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement.The more negative the value the better the result.



Eligibility Criteria

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:   All
Accepts Healthy Volunteers:   No
Criteria

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 wiling and able to provide informed consent and to participate all study procedures
  • Positive skin test to a prevalent spring allergen

Exclusion criteria:

  • On nasal examination,the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
  • Nasal disease likely to affect the deposition of the medication or evaluation, such as sinus infection, nasal polyps or severe deviated septum
  • Nasal or sinus surgery within the previous 6 months
  • Chronic sinus infection (more than 3 per year)
  • Planned travel outside the study area during the study period
  • Use of any investigational drug within 30 days of the first visit
  • Hypersensitivity (bad reaction) to azelastine hydrchloride nasal spray (Astelin), or fluticasone propionate nasal spray (Flonase)
  • Women who are not using an acceptable method or birth control
  • Women who are pregnant or nursing
  • Upper respiratory tract infection such as common cold, flu, sinus infection within 2 weeks of first study visit
  • Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with the investigator
  • Irregular heartbeat or other symptomatic heart conditions
  • History of alcohol or drug abuse
  • History of glaucoma
  • Use of medications that could affect the study results
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00651118


  Show 43 Study Locations
Sponsors and Collaborators
Meda Pharmaceuticals
Investigators
Study Director: Lewis M. Fredane, MD Meda Pharmaceuticals
More Information

Responsible Party: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00651118     History of Changes
Other Study ID Numbers: MP4002
First Posted: April 2, 2008    Key Record Dates
Results First Posted: September 26, 2012
Last Update Posted: September 26, 2012
Last Verified: August 2012

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