ID

30190

Beskrivning

Study ID: 102123 Clinical Study ID: FFR102123 Study Title: A randomised double-blind placebo controlled parallel group multicentre long term study to evaluate the safety of once-daily, intranasal administration of GW685698X aqueous nasal spray 100mcg* for 52 weeks in adult and adolescent subjects with perennial allergic rhinitis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: FLUTIDE, Allermist, Veramyst, FLUNASE, FLIXOTAIDE, FLUTAIDE, FLIXOVATE, Avamys; Veramyst, Avamys, Allermist Study Indication: Rhinitis, Allergic, Perennial This ODM-file contains Eligibility Criteria (Visit 1).

Nyckelord

Versioner (1)
  1. 18.05.18 18.05.18 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

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18. Mai 2018

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Creative Commons BY-NC 3.0
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Safety of once-daily administration of Fluticasone nasal spray in adults and adolescents with perennial allergic rhinitis GSK 102123

Engelsk

Eligibility Criteria

1 Formulär  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Eligibility Question
Beskrivning

Eligibility Question

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Beskrivning

Do not enter the subject into the study if they failed any inclusion or exclusion criteria in the other two itemgroups of this form.

Datatyp

text

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Subject has provided an appropriately signed and dated informed consent and one has been obtained from the subject’s parent or guardian if the child is under 18 years of age.
Beskrivning

Informed Consent (self or legal guardian)

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
UMLS CUI [2,3]
C0030551
Subjects must be ≥ 12 years of age at Visit 1, either gender, any ethnic group
Beskrivning

Age, Gender, Race

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0034510
Subject is treatable on an outpatient basis.
Beskrivning

Outpatient basis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0029921
UMLS CUI [1,3]
C0085732
Gender: Male or Female
Beskrivning

To be eligible for entry into the study, females of child-bearing potential must commit to consistent and correct use of an acceptable method of birth control, as defined by the following: Male partner who is sterile prior to the female subject’s entry into the study and is the sole sexual partner for that female subject Implants of levonorgestrel Injectable progestogen Oral contraceptive (either combined or progestin only) Double barrier method – spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a spermicide and female diaphragm). Any intrauterine device (IUD) with a documented failure rate of less than 1pecent per year, or Females of childbearing potential who are not sexually active and are not on one of the above acceptable methods of contraception must commit to complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days). Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test will be done at the screening visit to confirm female subjects are not pregnant upon entry into the study. Urine pregnancy tests will be done for all female subjects at each monthly visit.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
Diagnosis of PAR
Beskrivning

A positive skin test (by prick method) response to appropriate perennial allergen (animal dander, house dust mites, cockroach, mould) within last 12 months prior to Visit 1. A positive skin test is defined as a wheal ≥ 3mm larger than the diluent control for prick testing. Two year medical history and past treatment of PAR (written or verbal confirmation) which includes perennial, i.e., year-round, symptoms. PAR symptoms would include nasal congestion, rhinorrhoea, sneezing and itching. In vitro tests for specific IgE (such as RAST, PRIST) will not be allowed for the diagnosis of PAR. Note: Subjects who meet the above criteria and who also may have seasonal allergic rhinitis (SAR) or idiopathic/vasomotor rhinitis (VMR) are eligible for randomisation.

Datatyp

boolean

Alias
UMLS CUI [1]
C0035457
Subject understands and is willing, able and likely to comply with study procedures and restrictions.
Beskrivning

Understanding and willingness, Ability and likelihood of study compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
Subject must be able to read, comprehend, and record information in English, or native country language.
Beskrivning

read, comprehend, and record information in English, or native country language.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C1510558
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Significant concomitant medical condition
Beskrivning

a) A historical or current evidence of clinically significant uncontrolled disease of any body system (e.g., active tuberculosis, psychological disorders). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or which would confound the interpretation of the study results if the disease/ condition exacerbated during the study. b) a severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation that could affect the deposition of double blind intranasal study drug. c) recent (in the last 6 months) nasal septal or facial cosmetic surgery. d) asthma, with the exception of mild intermittent asthma [NAEPP, 2002] and the [GINA, 2003]. For Canada, see Canadian Asthma Consensus Report, [Boulet, 1999] for guidelines for very mild intermittent asthma). Subjects will be allowed to use short-acting inhaled beta2 agonists ONLY on an as needed basis. e) rhinitis medicamentosa. f) bacterial or viral infection (e.g., common cold) of the upper respiratory tract within two weeks of Visit 1 or during the screening period. g) documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator h) current or history of glaucoma and/or cataracts or ocular herpes simplex. i) physical impairment that would affect subject’s ability to participate in the study. j) clinical evidence of a Candida infection of the nose or oropharynx. k) 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. l) history of adrenal insufficiency.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
Use of corticosteroids
Beskrivning

Intranasal corticosteroid within four weeks prior to Visit 1. Inhaled, oral, intramuscular, intravenous, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1percent or less) within six months prior to Visit 1.

Datatyp

boolean

Alias
UMLS CUI [1]
C0001617
Use of other allergy medications within the timeframe indicated relative to Visit 1
Beskrivning

Intranasal cromolyn within 14 days prior to Visit 1. Short-acting prescription and OTC antihistamines, including ocular preparations and antihistamines contained in insomnia and ‘nighttime’ pain formulations taken for insomnia, within 3 days prior to Visit 1. Long-acting antihistamines within 10 days prior to Visit 1: loratadine, desloratadine, fexofenadine, cetirizine. Long-acting antihistamine, astemizole, within 12 weeks prior to Visit 1. Oral or intranasal decongestants within 72 hours of Visit 1. Intranasal, oral or inhaled anticholinergics within 72 hours prior to Visit 1. Oral antileukotrienes within 72 hours of Visit 1. Intranasal antihistamine such as Azelastine within 5 days prior to Visit 1.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
Use of other medications that may affect allergic rhinitis
Beskrivning

Chronic use of concomitant medications, such as tricyclic antidepressants, that would affect assessment of the effectiveness of the study drug. Chronic use of long-acting beta-agonists (e.g., salmeterol). Subcutaneous omalizumab (Xolair) within 5 months of Visit 1 Miacalcin (intranasal calcitonin) within 72 hours prior to Visit 1

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2607914
UMLS CUI [1,2]
C0013227
Use of immunosuppressive medications 8 weeks prior to Visit 1 and during the study
Beskrivning

immunosuppressive medications

Datatyp

boolean

Alias
UMLS CUI [1]
C0021081
Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole.
Beskrivning

Medications significantly inhibiting CYP3A4, including ritonavir and ketoconazole.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3830624
UMLS CUI [1,2]
C0292818
UMLS CUI [1,3]
C0022625
Known hypersensitivity to corticosteroids or any excipients in the product
Beskrivning

Allergy/Intolerance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3854006
Has received an investigational study drug for any indication within 30 days or 5 half-lives, whichever is longer, of Visit 1.
Beskrivning

Clinical trial/investigational medication experience

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
Has a positive urine pregnancy test at screening (Visit 1)
Beskrivning

Positive pregnancy test

Datatyp

boolean

Alias
UMLS CUI [1]
C0240802
Subject is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned.
Beskrivning

Affiliation with investigational site

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0035173
Findings of a clinically significant abnormal ECG
Beskrivning

Abnormal ECG

Datatyp

boolean

Alias
UMLS CUI [1]
C0522055
Findings of a clinically significant laboratory abnormality.
Beskrivning

Laboratory Abnormality

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
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Similar models

Eligibility Criteria

1 Formulär
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Eligibility Question
C0013893 (UMLS CUI-1)
Item
Did the subject meet all the entry criteria?
text
C0013893 (UMLS CUI [1])
Eligibility
Code List
Did the subject meet all the entry criteria?
CL Item
yes (Y)
CL Item
no (N)
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Informed Consent (self or legal guardian)
Item
Subject has provided an appropriately signed and dated informed consent and one has been obtained from the subject’s parent or guardian if the child is under 18 years of age.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
C0030551 (UMLS CUI [2,3])
Age, Gender, Race
Item
Subjects must be ≥ 12 years of age at Visit 1, either gender, any ethnic group
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0034510 (UMLS CUI [3])
Outpatient basis
Item
Subject is treatable on an outpatient basis.
boolean
C0087111 (UMLS CUI [1,1])
C0029921 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
Gender, Birth Control
Item
Gender: Male or Female
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Diagnosis of PAR
Item
Diagnosis of PAR
boolean
C0035457 (UMLS CUI [1])
Understanding and willingness, Ability and likelihood of study compliance
Item
Subject understands and is willing, able and likely to comply with study procedures and restrictions.
boolean
C1321605 (UMLS CUI [1])
read, comprehend, and record information in English, or native country language.
Item
Subject must be able to read, comprehend, and record information in English, or native country language.
boolean
C0233733 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0233733 (UMLS CUI [2,1])
C1510558 (UMLS CUI [2,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Significant concomitant medical condition
Item
Significant concomitant medical condition
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Use of corticosteroids
Item
Use of corticosteroids
boolean
C0001617 (UMLS CUI [1])
Use of other allergy medications within specific timeframe
Item
Use of other allergy medications within the timeframe indicated relative to Visit 1
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Use of other medications that may affect allergic rhinitis
Item
Use of other medications that may affect allergic rhinitis
boolean
C2607914 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
immunosuppressive medications
Item
Use of immunosuppressive medications 8 weeks prior to Visit 1 and during the study
boolean
C0021081 (UMLS CUI [1])
Medications significantly inhibiting CYP3A4, including ritonavir and ketoconazole.
Item
Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole.
boolean
C3830624 (UMLS CUI [1,1])
C0292818 (UMLS CUI [1,2])
C0022625 (UMLS CUI [1,3])
Allergy/Intolerance
Item
Known hypersensitivity to corticosteroids or any excipients in the product
boolean
C0020517 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Clinical trial/investigational medication experience
Item
Has received an investigational study drug for any indication within 30 days or 5 half-lives, whichever is longer, of Visit 1.
boolean
C2348568 (UMLS CUI [1])
Positive pregnancy test
Item
Has a positive urine pregnancy test at screening (Visit 1)
boolean
C0240802 (UMLS CUI [1])
Affiliation with investigational site
Item
Subject is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned.
boolean
C0439849 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
Abnormal ECG
Item
Findings of a clinically significant abnormal ECG
boolean
C0522055 (UMLS CUI [1])
Laboratory Abnormality
Item
Findings of a clinically significant laboratory abnormality.
boolean
C0438215 (UMLS CUI [1])
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