- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00368576
A Study To Determine The Effect Of SB-480848 On Asthma
A Randomised, Double-blind, Placebo-controlled, Parallel Group, Repeat Dose Study to Assess the Effect of SB-480848 on Overall Asthma Control in Adult Subjects With Persistent Asthma Controlled on Stable, Low-dose, Inhaled Corticosteroids
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Berlin, Germania, 14050
- GSK Investigational Site
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Bayern
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Neu-Ulm, Bayern, Germania, 89231
- GSK Investigational Site
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Schleswig-Holstein
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Grosshansdorf, Schleswig-Holstein, Germania, 22927
- GSK Investigational Site
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California
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Cypress, California, Stati Uniti, 90630
- GSK Investigational Site
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Illinois
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Normal, Illinois, Stati Uniti, 61761
- GSK Investigational Site
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Massachusetts
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North Dartmouth, Massachusetts, Stati Uniti, 02747
- GSK Investigational Site
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South Carolina
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Spartanburg, South Carolina, Stati Uniti, 29303
- GSK Investigational Site
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Male and female subjects who have documented persistent asthma for at least 3 months
- Subjects must have been on a stable, low-dose ICS for a minimum of 4 weeks prior to the screening visit.
- Aged 18-65 years, at screening
- FEV1 greater than or equal to 70% predicted (ECCS, 1993)
- Subjects must show an increase in FEV1 greater than or equal to 12% (and an absolute change >200mL) within 30 minutes following inhalation of 4 puffs of albuterol/salbutamol or 1 nebulized treatment of 2.5mg or have historical, documented evidence of reversibility, within 12 months prior to screening
- Subjects must be willing to replace their inhaled, short-acting β2-agonist with study provided albuterol/salbutamol
- Patient must be capable of giving informed consent and comply with the study requirements and timetable.
Inclusion Criteria following run in period (Prior to randomisation) Subjects will be screened based on the inclusion and exclusion criteria noted above.
During the run-in period [Day -14 to Day 1], subjects will be asked to maintain a diary card and document the number of puffs of rescue inhaled, short-acting β2-agonists taken, asthma-related symptoms and night time awakenings as well as morning and evening PEF measurements.
On the morning of Day 0, subjects will be eligible for randomisation into the study if all of the following criteria are met:
- Subjects required, on average less than or 2 puffs per day of study provided albuterol/ salbutamol during the last 7-day period prior to Day 0 [from Day -7 to Day 1]
- Subjects had asthma symptoms on less than or 5 out of the last 7 consecutive days of the run-in period
- FEV1 greater than or equal to 70% predicted (ECCS, 1993).
- FEV1 must be within ± 15% of the FEV1 value at beginning of screening.
- Compliance with completion of the diary card.
Exclusion criteria:
- The patient has life threatening asthma. A research patient must not have been hospitalized two or more times in the last year prior to Day 0 due to asthma and must not have been hospitalized within 6 months prior to Day 0
- Subjects with daily asthma-related symptoms.
- Subjects taking any of the medications listed in the protocol for the listed interval prior to the screening visit or during the study:
- Subjects with historical or current evidence of any other disease.
- Subjects with clinically significant abnormal findings on physical exam or other screening procedures.
- Subjects who have received an investigational product within 30 days or 5 half-lives [whichever is longer] prior to the first dose of study medication
- Subjects who have tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV.
- Subjects with history of drug or alcohol abuse
- Positive drug (not related to known medications the subject is taking at time of screening), alcohol or cotinine/carbon monoxide (CO) test at screening or at Day 0
- Subjects with a history of regularly drinking more than 2 (females)/3 (males) units of alcohol a day.
- Pregnant or nursing female subjects.
- Female subjects of childbearing potential with an unwillingness to agree to one of the methods of contraception listed in the protocol.
- Subjects who suffer from any medical condition which in the opinion of the investigator would compromise patient safety or ability to comply with study procedures
- Subjects who are current smokers or have given up smoking within the previous six months or who have a smoking history > 10 pack years.
- Subjects with history of an upper or lower respiratory tract infection or symptoms (including the common cold) within 2 weeks prior to first dose of study medication
- Subjects who have donated more than 500ml of blood within 56 days prior to the first dose of study medication
- Subjects who are currently receiving potent 3A4 inhibitors be excluded.
- Subjects on β-adrenergic receptor blockers within 3 months prior to screening visit
- Subjects previously hospitalized as a result of a methacholine challenge
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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FEV1
Lasso di tempo: 6 hours post-dose, Days 7, 14 and 21
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6 hours post-dose, Days 7, 14 and 21
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Methacholine challenge Amounts of certain chemicals/proteins in blood Amount of drug in the blood
Lasso di tempo: before dosing and after 21 days of dosing
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before dosing and after 21 days of dosing
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Measurements of FEV1 following single doses of SB-480848 and placebo.
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Measurements of PC20 on Day 21 +24hrs after dosing with SB-480848 and placebo.
Lasso di tempo: Day 21 +24hrs after dosing
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Day 21 +24hrs after dosing
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Blood drug levels of SB-553253 [metabolite of SB-480848] may be assessed, as appropriate.
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Urinary leukotriene concentrations after 21 days of dosing with SB-480848 and Placebo.
Lasso di tempo: after 21 days
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after 21 days
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Blood levels of LpPLA2 and CD62 concentrations over 21-day dosing period with SB-480848 and placebo
Lasso di tempo: over 21-day dosing period
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over 21-day dosing period
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Measurements of FEF25-75 and peak expiratory flow following single and repeat oral doses of SB-480848.
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Assessment of vitals, ECGs, safety labs and number of puffs of rescue inhaled, short-acting β2-agonists taken, asthma-related symptoms and night time awakenings, number of subjects withdrawn due to worsening of asthma on SB- 480848 and placebo.
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattia cardiovascolare
- Malattie vascolari
- Malattie delle vie respiratorie
- Malattie del sistema immunitario
- Arteriosclerosi
- Malattie arteriose occlusive
- Malattie polmonari
- Ipersensibilità, immediata
- Malattie bronchiali
- Malattie polmonari, ostruttive
- Ipersensibilità respiratoria
- Ipersensibilità
- Asma
- Aterosclerosi
Altri numeri di identificazione dello studio
- LPL107629
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Dati/documenti di studio
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Modulo di consenso informato
Identificatore informazioni: LPL107629Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Rapporto di studio clinico
Identificatore informazioni: LPL107629Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Protocollo di studio
Identificatore informazioni: LPL107629Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Set di dati del singolo partecipante
Identificatore informazioni: LPL107629Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Piano di analisi statistica
Identificatore informazioni: LPL107629Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Modulo di segnalazione del caso annotato
Identificatore informazioni: LPL107629Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Specifica del set di dati
Identificatore informazioni: LPL107629Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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