Clinical Trials Register

Summary
EudraCT Number:	2009-015014-22
Sponsor's Protocol Code Number:	FFS113203
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2009-12-17
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2009-015014-22

A.3

Full title of the trial

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.

A.4.1

Sponsor's protocol code number

FFS113203

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GlaxoSmithKline Research & Development Ltd
B.1.3.4	Country	United Kingdom
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Avamys
D.2.1.1.2	Name of the Marketing Authorisation holder	Glaxo Group Ltd
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	AVAMYS 27.5 micrograms/spray (nasal spray suspension)
D.3.2	Product code	GW685698X
D.3.4	Pharmaceutical form	Nasal spray, suspension
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Nasal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	fluticasone furoate
D.3.9.2	Current sponsor code	FF113203
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	27.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Nasal spray, suspension
D.8.4	Route of administration of the placebo	Nasal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Uncomplicated acute rhinosinusitis

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.0
E.1.2	Level	LLT
E.1.2	Classification code	10052106
E.1.2	Term	Rhinosinusitis

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

E.2.2

Secondary objectives of the trial

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.

E.2.3

Trial contains a sub-study

E.3

Principal 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.

E.4

Principal 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 intranasal antihistamines within three days prior to Visit 1
•Oral or intranasal decongestants within 72 hours prior to Visit 1
•Long-acting beta-agonists within 72 hours prior to Visit 1
•Intranasal, oral, or inhaled anticholinergics within 72 hours prior to Visit 1
•Cimetidine, ranitidine, famotidine, nizatidine within one day prior to Visit 1
•Oral antileukotrienes within 72 hours of Visit 1
•Subcutaneous omalizumab within five months of Visit 1
•Chronic use of concomitant medications, such as tricyclic antidepressants, that would affect assessment of the effectiveness of the study drug
•Use of other intranasally administered medications
13. Use of immunosuppressive medications eight weeks prior to screening and during the study
14. Immunotherapy: Patients may be enrolled in study if immunotherapy was not initiated within 30 days of Visit 1, if dose has remained fixed over 30 days prior to Visit 1, and dose will remain fixed for duration of study.
15. Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole
16. Clinical trial/experimental medication experience
Has recent exposure to an investigational study drug within 30 days of Visit 1
17. Positive pregnancy test or inconclusive pregnancy test (Visit 1/ 2) or female who is breastfeeding.
18. Affiliation with investigational site
19. Current tobacco use
20. Chicken pox or measles

E.5 End points

E.5.1

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.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last subject, last visit

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

447

F.4.2.2

In the whole clinical trial

765

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

No further treatment will be provided to subjects once study completion has occurred

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2010-02-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-02-11

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2010-07-16

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