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:	NCT00660517

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: fluticasone propionate Drug: azelastine Hcl/fluticasone propionate nasal spray	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, Astelin 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 ]
Change from Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: 14 Days ] [ Designated as safety issue: No ]

Enrollment:	610
Study Start Date:	December 2007
Study Completion Date:	April 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: placebo	Drug: Placebo placebo nasal spray is the same formulation and excipients as other treatment arms but without an active ingredient Other Name: no other name
Active Comparator: azelastine Hcl 548 mcg	Drug: azelastine Hcl azelastine Hcl 548 mcg nasal spray Other Name: Astelin
Active Comparator: fluticasone propionate 200 mcg	Drug: fluticasone propionate fluticasone propionate 200 mcg Other Name: generic Flonase
Experimental: azelastine Hcl/ fluticasone propionate azelastine Hcl/ fluticasone propionate	Drug: azelastine Hcl/fluticasone propionate nasal spray azelastine Hcl548 mcg/fluticasone propionate 200 mcg Other Name: MP29-02

Detailed Description:

This will be a Phase III, randomized, double-blind, parallel-group study in subjects with moderate-to-severe SAR. The study will be conducted at 8 investigational sites during the 2007-2008 Texas Mountain Cedar allergy season. After a 7-day 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), consisting of the sum of the scores of sneezing, nasal congestion, runny nose, and nasal itching. On Days -7 through 14, subjects will rate the TNSS symptoms, the 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. The 12-hour reflective TNSS, the instantaneous TNSS, the 12-hour reflective score for postnasal drip, the 12-hour reflective TOSS, and the instantaneous TOSS will be calculated based on these scores. Additional secondary efficacy variables will include reflective and individual nasal and ocular symptom scores and change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).

Subjects ≥ 18 years of age will complete the adult 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 subjects 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 willing and able to provide informed consent and to participate in all study procedures
Positive skin test to a prevalent Texas Mountain Cedar allergen

Exclusion Criteria:

On Focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation (Grade 1b - 4) 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 study area during the study period
The use of any investigational drug within 30 days prior to Day screening. No investigational products are permitted for use during the conduct of this study
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* see section 6.1.1
Respiratory Tract Infections within 14 days prior to Day screening
Respiratory Tract Infections requiring antibiotic treatment 14 days prior to screening
Asthma (with the exception of mild, intermittent asthma). Subjects with mild, 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
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.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660517

Locations

United States, Texas
Allergy and Asthma Associates
Austin, Texas, United States, 78731
Central Texas Research
New Braunfels, Texas, United States, 78130
Sylvana Research Associates
San Antonio, Texas, United States, 78229
Allergy, Asthma Research Center
San Antonio, Texas, United States, 78258
Southwest Allergy and Asthma Center, P.A.
San Antonio, Texas, United States, 78229
Allergy and Asthma Care
Waco, Texas, United States, 76708
Allergy and Asthma Center
Waco, Texas, United States, 76712

Sponsors and Collaborators

Meda Pharmaceuticals

Investigators

Study Director:

Lewis M Fredane, MD

Meda Pharmaceuticals

More Information

No publications provided by Meda Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hampel FC, Ratner PH, Van Bavel J, Amar NJ, Daftary P, Wheeler W, Sacks H. Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device. Ann Allergy Asthma Immunol. 2010 Aug;105(2):168-73.

Responsible Party:	Harry Sacks, MD Vice President, Medical and Scientific Affairs
ClinicalTrials.gov Identifier:	NCT00660517 History of Changes
Other Study ID Numbers:	MP4001
Study First Received:	April 14, 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 09, 2012