Dose Finding Study of Fluticasone Furoate Nasal Spray for Uncomplicated Acute Rhinosinusitis

NCT ID: NCT01018030

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 741 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-06
• Study Completion Date: 2010-07-16

Brief Summary

The purpose of this study is to assess the safety and efficacy of fluticasone furoate nasal spray (FFNS), without the use of an antibiotic, in the treatment of adult and adolescent subjects who are 12 years of age and older with uncomplicated acute rhinosinusitis (ARS).

Detailed Description

• Rationale - Acute rhinosinusitis (ARS) is a condition caused by inflammation of the nose and the paranasal sinuses that generally lasts up to 4 weeks. Despite ARS being a self-limiting condition, untreated or inadequately treated sinus infection can lead to the development of complications. Uncomplicated ARS is a subset of ARS and is distinguished from the common cold by the persistence or the worsening of sinus inflammation after the usual period for recovery of viral infection of the nasal cavity (i.e., 10 days). Clinically the difference is based on the following criteria: symptoms are present at least 10 days but less than 4 weeks beyond the onset of upper respiratory symptoms OR symptoms worsen after 5 days from their onset.

In the primary care settings, ARS is often treated empirically with antibiotics although they are shown to provide limited benefit in the uncomplicated ARS population. Alternatively, the use of an intranasal corticosteroid (INS) to control symptoms of uncomplicated ARS is plausible based on clinically proven ability to reduce inflammation and mucosal swelling.

This study is a phase II study.

• Objective - The objective of this study is to evaluate the safety and efficacy of two doses of FFNS (110 mcg once daily and 110 mcg twice daily) compared to placebo as monotherapy in the treatment of adult and adolescent subjects 12 years of age and older with uncomplicated ARS.
• Study Design - This is a randomized, double-blind, placebo controlled, parallel group, multi-centre, 2-week treatment study. The study includes a 2-week post-treatment follow-up period.

Approximately 720 subjects will be randomized to one of three treatment groups for a period of 14 days: FFNS 110 mcg QD, FFNS 110 mcg BID, and placebo nasal spray.

Conditions

Sinusitis, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FFNS 110 mcg QD

Group Type: EXPERIMENTAL

FFNS 110 mcg QD

Intervention Type: DRUG

Active Nasal Spray (AM) and Placebo Nasal Spray (PM)

FFNS 110 mcg BID

Group Type: EXPERIMENTAL

FFNS 110 mcg BID

Intervention Type: DRUG

Active Nasal Spray (AM) and Active Nasal Spray (PM)

Placebo Nasal Spray

Group Type: PLACEBO_COMPARATOR

Placebo Nasal Spray

Intervention Type: DRUG

Placebo Nasal Spray (AM) and Placebo Nasal Spray (PM)

Interventions

FFNS 110 mcg QD

Active Nasal Spray (AM) and Placebo Nasal Spray (PM)

Intervention Type: DRUG

FFNS 110 mcg BID

Active Nasal Spray (AM) and Active Nasal Spray (PM)

Intervention Type: DRUG

Placebo Nasal Spray

Placebo Nasal Spray (AM) and Placebo Nasal Spray (PM)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Informed consent

2. Outpatient

3. Age (>= 18 years at Visit 1 for Russia, Ukraine, and Germany; >= 12 years at Visit 2 for all other countries)

4. Diagnosis of uncomplicated acute rhinosinusitis

5. Ability and willingness to comply with study procedures and restrictions.

6. Male or eligible female - Female subjects should not be enrolled if they plan to become pregnant during the time of study participation; To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control.

7. Literate

Exclusion Criteria

1. Based on the investigator's clinical judgement, subject has fulminant bacterial rhinosinusitis during the screening period including Visits 1 and 2.

2. A history of acute rhinosinusitis within 12 weeks prior to the current episode as determined by the investigator

3. Current or a history of other sinonasal conditions (e.g., chronic or recurrent rhinosinusitis, non-allergic rhinitis) within 3 years prior to Visit 1 as determined by the investigator

4. Symptomatic perennial or seasonal allergic rhinitis prior to ARS episode, or allergy to seasonal allergens likely to be present during the study period (as determined by documented skin prick test or in vitro blood test).

5. Significant concomitant medical conditions

6. Subjects with planned elective surgery, vacation or other event during the study period which could prevent the subject from participating in the study according to protocol specifications

7. Use of antibiotics within 30 days prior to Visit 1 for sinopulmonary infections.

8. Use of antiviral medications such as zanamivir and oseltamivir within 30 days prior to Visit 1

9. Use of analgesics or antipyretics within 1 day prior to Visit 1

10. Known hypersensitivity or allergy to corticosteroids or any excipients in the product

11. Use of corticosteroids, defined as:

12. Use of any other medications that may affect nasal symptoms

13. Use of immunosuppressive medications eight weeks prior to screening and during the study

14. Immunotherapy

15. Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole

16. Clinical trial/experimental medication experience

17. Positive pregnancy test or inconclusive pregnancy test or female who is breastfeeding

18. Affiliation with investigational site

19. Current tobacco use

20. Chicken pox or measles

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Rousse, , Bulgaria

GSK Investigational Site

Sofia, , Bulgaria

GSK Investigational Site

Sofia, , Bulgaria

GSK Investigational Site

Sofia, , Bulgaria

GSK Investigational Site

Varna, , Bulgaria

GSK Investigational Site

Chilliwack, British Columbia, Canada

GSK Investigational Site

Kelowna, British Columbia, Canada

GSK Investigational Site

Surrey, British Columbia, Canada

GSK Investigational Site

Winnipeg, Manitoba, Canada

GSK Investigational Site

Winnipeg, Manitoba, Canada

GSK Investigational Site

Ajax, Ontario, Canada

GSK Investigational Site

Brampton, Ontario, Canada

GSK Investigational Site

Greater Sudbury, Ontario, Canada

GSK Investigational Site

Hamilton, Ontario, Canada

GSK Investigational Site

London, Ontario, Canada

GSK Investigational Site

Mississauga, Ontario, Canada

GSK Investigational Site

Newmarket, Ontario, Canada

GSK Investigational Site

Oshawa, Ontario, Canada

GSK Investigational Site

Ottawa, Ontario, Canada

GSK Investigational Site

Sarnia, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Woodstock, Ontario, Canada

GSK Investigational Site

Granby, Quebec, Canada

GSK Investigational Site

Pointe-Claire, Quebec, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Saskatoon, Saskatchewan, Canada

GSK Investigational Site

Benešov, , Czechia

GSK Investigational Site

Brno, , Czechia

GSK Investigational Site

Hradec Králové, , Czechia

GSK Investigational Site

Pardubice, , Czechia

GSK Investigational Site

Prague, , Czechia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Weinheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Nuremberg, Bavaria, Germany

GSK Investigational Site

Ketzin, Brandenburg, Germany

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

GSK Investigational Site

Wiesbaden, Hesse, Germany

GSK Investigational Site

Hanover, Lower Saxony, Germany

GSK Investigational Site

Duisburg, North Rhine-Westphalia, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Goch, North Rhine-Westphalia, Germany

GSK Investigational Site

Delitzsch, Saxony, Germany

GSK Investigational Site

Schmölln, Thuringia, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Almere Stad, , Netherlands

GSK Investigational Site

Beek, , Netherlands

GSK Investigational Site

Etten-Leur, , Netherlands

GSK Investigational Site

Losser, , Netherlands

GSK Investigational Site

Nijmegen, , Netherlands

GSK Investigational Site

Woerden, , Netherlands

GSK Investigational Site

Ålesund, , Norway

GSK Investigational Site

Bekkestua, , Norway

GSK Investigational Site

Elverum, , Norway

GSK Investigational Site

Hamar, , Norway

GSK Investigational Site

Hønefoss, , Norway

GSK Investigational Site

Nesttun, , Norway

GSK Investigational Site

Stavanger, , Norway

GSK Investigational Site

Lublin, , Poland

GSK Investigational Site

Tarnów, , Poland

GSK Investigational Site

Wroclaw, , Poland

GSK Investigational Site

Wroclaw, , Poland

GSK Investigational Site

Zawadzkie, , Poland

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Benidorm/Alicante, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Oviedo, , Spain

GSK Investigational Site

Petrer/Alicante, , Spain

GSK Investigational Site

Talavera de La Reina (Toledo), , Spain

GSK Investigational Site

Gothenburg, , Sweden

GSK Investigational Site

Gothenburg, , Sweden

GSK Investigational Site

Lidingö, , Sweden

GSK Investigational Site

Lund, , Sweden

GSK Investigational Site

Stockholm, , Sweden

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Odesa, , Ukraine

GSK Investigational Site

Symferopil, , Ukraine

GSK Investigational Site

Zaporizhzhya, , Ukraine

Countries

Bulgaria; Canada; Czechia; Estonia; Germany; Netherlands; Norway; Poland; Russia; Spain; Sweden; Ukraine

References

Keith PK, Dymek A, Pfaar O, Fokkens W, Yun Kirby S, Wu W, Garris C, Topors N, Lee LA. Fluticasone furoate nasal spray reduces symptoms of uncomplicated acute rhinosinusitis: a randomised placebo-controlled study. Prim Care Respir J. 2012 Sep;21(3):267-75. doi: 10.4104/pcrj.2012.00039.

Reference Type: BACKGROUND

PMID: 22614920 (View on PubMed)

Other Identifiers

113203

Identifier Type: -

Identifier Source: org_study_id