Clinical trial NCT01279057: A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
Official title: A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Fluticasone Furoate Nasal Spray (Lek Pharmaceuticals) With Veramyst® Nasal Spray (GlaxoSmithKline) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Seasonal
Keywords: Rhinitis
Seasonal Allergic Rhinitis
Fluticasone furoate
Equivalence
Hay fever
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2011-01-19
Enrollment: 727
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compared the safety and efficacy of a generic fluticasone furoate (Lek Pharmaceuticals) nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.

Detailed description: The study was designed as a double-blind, randomized, placebo-controlled, parallel group, multi-site to compare the clinical equivalence of the test formulation of fluticasone furoate, 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals d.d.) with the reference formulation Veramyst® nasal spray (GlaxoSmithKline) in the relief of the signs and symptoms of seasonal allergic rhinitis. Participants who met the inclusion/exclusion criteria entered a 7-day placebo lead-in period. Following this placebo lead-in period, on Day 1 participants who continued to meet eligibility criteria were randomly assigned in a 2:2:1 ratio to one of three treatment groups (Test Product:Reference Product:Placebo) for 14 days of treatment. In all treatment groups, participants were instructed to administer the study drug once daily at approximately the same time each day. A single dose of 110 mcg was 4 actuations, each containing 27.5 mcg per actuation. Patients were instructed to administer the 4 actuations alternating between right and left nostril, such that 2 actuations were not administered back to back to the same nostril.

Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant, non-lactating female 12 years of age or older with a minimum of 2 years of previous history of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
* Signed informed consent (assent) form.
* Documented positive allergic skin test to local pollen.
* An average score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) with a minimum score of at least 2 for "nasal congestion" and at least 4 on the reflective Total Ocular Symptom Score (rTOSS).

Exclusion Criteria:

* History of asthma that required chronic therapy (with the exception of occasional acute or mild exercise induced asthma).
* Some other past and concomitant medical conditions, prohibited medications.
* Upper respiratory tract infection or any untreated infections.
* Patient has started immunotherapy/changed the dose.
* Any known allergy to any of the components of the study nasal spray.

Primary outcomes:
measure: PRIMARY: Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Equivalence: Per-Protocol Population)
timeFrame: Baseline, 14 days
measure: PRIMARY: Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Superiority: Intent-to-Treat Population)
timeFrame: Baseline, 14 days
Secondary outcomes:
measure: Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Equivalence: Per-Protocol Population)
timeFrame: Baseline, 14 days
measure: Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Superiority: Intent-to-Treat Population)
timeFrame: Baseline, 14 days
measure: Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) (Equivalence: Per-Protocol Population)
timeFrame: Baseline, 14 days
measure: Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) (Superiority: Intent-to-Treat Population)
timeFrame: Baseline, 14 days
measure: Mean Change From Baseline in Instantaneous Total Ocular Symptom Score (iTOSS) (Equivalence: Per-Protocol Population)
timeFrame: Baseline, 14 days
measure: Mean Change From Baseline in Instantaneous Total Ocular Symptom Score (iTOSS) (Superiority: Intent-to-Treat Population)
timeFrame: Baseline, 14 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: Sandoz Investigational Site
state: Texas
city: Austin
country: United States
facility: Sandoz Investigational Site
state: Texas
city: Austin
country: United States
facility: Sandoz Investigational Site
state: Texas
city: Kerrville
country: United States
facility: Sandoz Investigational Site
state: Texas
city: New Braunfels
country: United States
facility: Sandoz Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Sandoz Investigational Site
state: Texas
city: Waco
country: United States
facility: Sandoz Investigational Site
state: Texas
Study officials:
References: