A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

NCT01279057 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 71047201
• Study Type: interventional
• Target: 727
• Locations: 1 country
• Sites: 7

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.

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Rhinitis; Seasonal Allergic Rhinitis; Fluticasone furoate; Equivalence; Hay fever

Outcome Measures

Primary Outcomes (2)

• PRIMARY: Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Equivalence: Per-Protocol Population)

  Patients were required to record a 12 hour "reflective" score twice a day approximately 12 hours apart. For the rTNSS patients were asked to "look back" or "reflect" on their severity of nasal symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms. Mean baseline rTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period. Mean change from baseline was calculated as "mean baseline rTNSS" - "mean post-randomization rTNSS". A positive change from baseline in rTNSS is considered a favorable outcome.

  Baseline, 14 days

• PRIMARY: Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Superiority: Intent-to-Treat Population)

  Patients were required to record a 12 hour "reflective" score twice a day approximately 12 hours apart. For the rTNSS patients were asked to "look back" or "reflect" on their severity of nasal symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms. Mean baseline rTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period. Mean change from baseline was calculated as "mean baseline rTNSS" - "mean post-randomization rTNSS". A positive change from baseline in rTNSS is considered a favorable outcome.

  Baseline, 14 days

Secondary Outcomes (6)

• Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Equivalence: Per-Protocol Population)

  Baseline, 14 days

• Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Superiority: Intent-to-Treat Population)

  Baseline, 14 days

• Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) (Equivalence: Per-Protocol Population)

  Baseline, 14 days

• Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) (Superiority: Intent-to-Treat Population)

  Baseline, 14 days

• Mean Change From Baseline in Instantaneous Total Ocular Symptom Score (iTOSS) (Equivalence: Per-Protocol Population)

  Baseline, 14 days

Study Arms (3)

Test

EXPERIMENTAL

Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.

Drug: Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals)

Reference

ACTIVE COMPARATOR

Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.

Drug: Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray

Placebo

PLACEBO COMPARATOR

Placebo nasal spray administered once daily for 14 days.

Drug: Placebo

Interventions

Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) DRUG

Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.

Test

Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray DRUG

Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.

Reference

Placebo DRUG

Placebo nasal spray administered once daily (4 actuations) for 14 days.

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sandoz: lead

Study Sites (7)

Sandoz Investigational Site

Austin, Texas, 78731, United States

Location

Sandoz Investigational Site

Austin, Texas, 78750, United States

Location

Sandoz Investigational Site

Austin, Texas, 78759, United States

Location

Sandoz Investigational Site

Kerrville, Texas, 78028, United States

Location

Sandoz Investigational Site

New Braunfels, Texas, 78130, United States

Location

Sandoz Investigational Site

San Antonio, Texas, 78229, United States

Location

Sandoz Investigational Site

Waco, Texas, 76712, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Rhinitis

Interventions

fluticasone furoate; Fluticasone

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2011
• First Posted: January 19, 2011
• Study Start: December 27, 2010
• Primary Completion: February 8, 2011
• Study Completion: February 8, 2011
• Last Updated: February 3, 2021
• Results First Posted: February 3, 2021

Record last verified: 2021-01

Locations

US (7)