A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies - Full Text View

Sponsor:	Meda Pharmaceuticals
Information provided by:	Meda Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00651118

Purpose

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	Intervention	Phase
Seasonal Allergic Rhinitis	Drug: Placebo Drug: azelastine Hcl Drug: azelastineHcl / fluticasone propionate Drug: fluticasone propionate	Phase III

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 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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Hay Fever

Drug Information available for: Azelastine Azelastine hydrochloride Fluticasone propionate Fluticasone

U.S. FDA Resources

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:	832
Study Start Date:	March 2008
Study Completion Date:	July 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Other Name: placebo
Active Comparator: azelastine Hcl	Drug: azelastine Hcl azelastine Hcl 548 mcg Other Name: azelastine

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.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651118

Show 43 Study Locations

Sponsors and Collaborators

Meda Pharmaceuticals

Investigators

Study Director:

Lewis M. Fredane, MD

Meda Pharmaceuticals

More Information

No publications provided

Responsible Party:	David Ginsberg,DO Medical and Scientific Affairs, Meda Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00651118 History of Changes
Other Study ID Numbers:	MP4002
Study First Received:	March 28, 2008
Last Updated:	July 12, 2011
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
Fluticasone
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
Dermatologic Agents

ClinicalTrials.gov processed this record on February 12, 2012