A randomized, double-blind, placebo controlled, parallel group, multi-centre, 2-week treatment study to evaluate the safety and efficacy of fluticasone furoate nasal spray (FFNS) 110 mcg, administered either once daily or twice daily, compared with placebo, as effective monotherapy in the treatment of uncomplicated acute rhinosinusitis (ARS) in adult and adolescent subjects 12 years of age and older.

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-015014-22-SE
• Date of registration: 18/11/2009
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Research & Development Ltd
• Public title: A randomized, double-blind, placebo controlled, parallel group, multi-centre, 2-week treatment study to evaluate the safety and efficacy of fluticasone furoate nasal spray (FFNS) 110 mcg, administered either once daily or twice daily, compared with placebo, as effective monotherapy in the treatment of uncomplicated acute rhinosinusitis (ARS) in adult and adolescent subjects 12 years of age and older.
• Scientific title: A randomized, double-blind, placebo controlled, parallel group, multi-centre, 2-week treatment study to evaluate the safety and efficacy of fluticasone furoate nasal spray (FFNS) 110 mcg, administered either once daily or twice daily, compared with placebo, as effective monotherapy in the treatment of uncomplicated acute rhinosinusitis (ARS) in adult and adolescent subjects 12 years of age and older.
• Date of first enrolment: 20/01/2010
• Target sample size: 765
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015014-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Bulgaria, Czech Republic, Estonia, Germany, Netherlands, Spain, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
1. Informed consent
Subject has provided an informed consent to participate. An appropriately signed and dated consent must be obtained from the parents or guardian of a subject who is under the legal age of consent.
2. Outpatient
Subject can be treated on an outpatient basis
3. Age
• = 12 years at Visit 2
• = 18 years at Visit 1 for Russia, Ukraine, and Germany
4. Diagnosis of uncomplicated acute rhinosinusitis
•Subject has two or more major symptoms of uncomplicated acute rhinosinusitis [nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip];
•One symptom must be sinus headache/pressure or facial pain/pressure; and
•Subject has experienced symptoms for at least 5 days and no more than 8 days prior to the screening visit (Visit 1).
5. Ability and willingness to comply with study procedures and restrictions.
Subject understands and is willing, able, and likely to comply with study procedures and restrictions. The subject understands that they may not take medication for the treatment of rhinosinusitis symptoms during the screening period and may only take allocated study drug during the treatment period.
6. Male or eligible female
Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test will be performed for all females of childbearing potential at Visits 1, 2, 4, and/or Early Withdrawal to determine if the subject is pregnant.
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, as defined by the following:
•Abstinence
Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse starting on the day of Visit 1, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days).
•Oral contraceptive (either combined estrogen/progestin or progestin only)
•Injectable progestogen
•Implants of levonorgestrel
•Percutaneous contraceptive patches
•Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year,
•Male partner who is sterile (vasectomy with documentation of azoopermia) prior to the female subject’s entry into the study and is the sole sexual partner for that female subject, or
•Double-barrier method; condom or occlusive cap (diaphragm or cervical /vault caps) plus spermacide.
7. Literate
Subject must be able to read, comprehend, and record information as appropriate.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Subject has fulminant bacterial rhinosinusitis during screening period including Visits 1 and 2. Signs and symptoms suggestive of fulminant bacterial rhinosinusitis include history of fever > 100.4°F/38.0°C for more than 3 days prior to Visit 1 since the start of symptoms due to the current episode of rhinosinusitis or current fever > 100.4°F/38.0°C at or after Visit 1, persistent severe unilateral facial or tooth pain, facial swelling or dental involvement.
2. History of ARS within 12 weeks prior to current episode.
3. Current or history of other sinonasal conditions within 3 years prior to Visit 1
4. Symptomatic PAR or SAR prior to ARS episode, or allergy to seasonal allergens likely to be present during study period (as per skin prick test or in vitro blood test).
5. Significant concomitant medical conditions, defined as but not limited to:
a. Historical or current evidence of clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema, immunosuppressive disorders). Please view protocol.
b. Asthma, with the exception of mild intermittent asthma, or very mild asthma (Canada)
c. Current or history of glaucoma and/or cataracts or ocular herpes simplex
d. History of impaired renal function
e. History of Hepatitis B or C
f. History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse (including drug and alcohol) or other conditions that will limit the validity of informed consent or that would confound the interpretation of the study results
g. Influenza (e.g., pandemic flu such as swine H1N1 flu). Please view protocol.
h. Clinical evidence of a Candida infection of the nose
i. Nasal ulcer(s) at randomization (Visit 2)
j. Nasal injury/surgery in last 3 months or subjects likely to require corrective or reconstructive surgery during study period.
k. Physical obstruction of nose or nasal septal perforation that could affect deposition of double blind intranasal study drug
l. Otitis media
m. Physical impairment that would affect subject’s ability to participate safely and fully in study
n. Rhinitis medicamentosa or atrophic rhinitis
o. Sleep apnea
6. Subjects with planned elective surgery, vacation or other event during the study period which could prevent subject from participating in 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 oseltmivir 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 product
11. Use of corticosteroids, defined as:
•Intranasal corticosteroid within four weeks prior to Visit 1. Please view protocol.
•Use of inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to Visit 1.
12. Use of any other medications that may affect nasal symptoms within the timeframe indicated relative to Visit 1. Please view protocol for further information:
•Intranasal cromolyn within 14 days prior to Visit 1
•Short-acting prescription and non-prescription antihistamines, including antihistamines contained in insomnia and “night time” pain formulations, within three days prior to Visit 1
•Long-acting, non-sedating antihistamines within three days prior to Visit 1
•Ocular or in

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Uncomplicated acute rhinosinusitis
MedDRA version: 12.0 Level: LLT Classification code 10052106 Term: Rhinosinusitis

Intervention(s)

Trade Name: Avamys
Product Name: AVAMYS 27.5 micrograms/spray (nasal spray suspension)
Product Code: GW685698X
Pharmaceutical Form: Nasal spray, suspension
Pharmaceutical form of the placebo: Nasal spray, suspension
Route of administration of the placebo: Nasal use

Primary Outcome(s)

Main 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.

Primary end point(s): The primary efficacy endpoint for the study is the mean change from baseline in daily major symptom score (MSS) over the entire treatment period. The MSS is the sum of three individual symptom scores for (1) nasal congestion/stuffiness, (2) sinus headache/pressure or facial pain/pressure, and (3) postnasal drip that are rated by the subject using a 0 to 3 scale.

Secondary Objective: The optimal dose of FFNS in treating uncomplicated ARS will be selected based on the results from this study and used for a subsequent confirmatory phase III study.

Secondary ID(s)

FFS113203

2009-015014-22-EE