Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Bronchodilator Properties and Safety in Asthma

16. september 2014 opdateret af: Pierre Fabre Medicament

Bronchodilator Properties and Safety of a Repeated Dose of V0162 in Asthma.

Recent large clinical studies have demonstrated the interest of LAMA therapy in the management of asthma, when compared to LABA.

V0162 is a compound with a very long lasting bronchodilator effect when compared to reference treatment in non-clinical models and in COPD patients. Secondary properties of V0162 (i.e.H1/H4 and PDE IV-inhibition) could enhance the efficacy of this antimuscarinic compound and could bring option in the treatment obstructive lung disease. The objective of the study is to assess the bronchodilator properties of V0162 during 8 days in adult patients with asthma usually treated with ICS and LABA. The study is a randomised, double-blind, placebo-controlled, 3-period crossover, preceded by an open-label active-control period before randomisation.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

59

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Aged 18 to 65 years-old.
  • 18 ≤ BMI <30 kg/m².
  • Clinical history consistent asthma, in the judgement of the investigator.
  • Asthma controlled or partly controlled according to GINA 2012 criteria:
  • Asthma treated by ICS and LABA (fixed-dose combination or free combination) at stable dose for at least 3 months.
  • Able to replace the usual ICS and LABA therapy by ICS at the usual dose regimen and salbutamol as needed.
  • Able to stop salbutamol at least 6 hours before a study visit.
  • Able to perform at least 3 acceptable and reproducible FEV1 and FVC measurements according to ERS/ATS 2005 recommendations.

Exclusion Criteria:

  • Clinically significant respiratory conditions other than asthma (e.g. pneumonia, pneumothorax, atelectasis, bronchiectasis, chronic bronchitis, COPD, emphysema, pulmonary arterial hypertension, pulmonary fibrosis,etc.).
  • Upper or lower respiratory tract infection within 4 weeks.
  • Exacerbation (requiring oral corticosteroids or hospitalization) within 3 months.
  • Current smoker or former smoker less than 6 months or total lifetime smoking history greater than 10 pack-years.
  • Intolerance to salbutamol.
  • Intolerance to tiotropium (or any other atropine-derived compound).
  • Intolerance to one of the ingredients of the study product
  • Severe hepatic impairment, moderate to severe renal impairment, epilepsy, narrow angle glaucoma, gastrointestinal obstruction, moderate to severe prostatic hypertrophy, bladder neck obstruction.
  • Any acute or chronic disease that will not allow the participation in the study, in the judgement of the investigator.
  • Clinically relevant physical examination abnormality.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: placebo
Placebo
Andet: Placebo
Eksperimentel: V0162 dose1
Medicin: V0162
Eksperimentel: V0162 dose2
Medicin: V0162

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Normalised AUC 0-24h of FEV1 at day 8 of treatment period
Tidsramme: At the 8th day of treatment period
FEV1 assessed by spirometry
At the 8th day of treatment period

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Parameters of the pulmonary function
Tidsramme: Day 1 and Day 8 of treatment period

as well as the following criteria assessed the first day and the last day of each treatment period and the difference between the last day and the first day within each treatment periodadjusted for placebo effect:

  • the normalised AUC0-9h of FEV1 (L),
  • the normalised AUC0-12h of FEV1 (L),
  • the peak of FEV1 (L) which is the higher observed post-dosing value,
  • the trough of FEV1 (L) which is the last measurement before the next dosing (i.e. t24h),
  • the normalised AUC0-9h,AUC0-12h, AUC0-24h, peak and trough of FVC, MEF25, MEF50, MEF75, and MEF25-75.
Day 1 and Day 8 of treatment period
PEF
Tidsramme: Morning and evening from Day 1 to day 8 of treatment period
PEF measured using a peak-flow meter
Morning and evening from Day 1 to day 8 of treatment period
Dyspnoea
Tidsramme: Day 1 to Day 8 of treatment period
The criteria will be the normalised AUC0-9h,AUC0-12h, and AUC0-24h of the dyspnoea measurements(mm) assessed the first and the last day of each treatment period, and the difference between the last and the first day within each treatment period.
Day 1 to Day 8 of treatment period
Vital signs
Tidsramme: Visit 2, and at Visit 3 to Visit 10 (within 30 min pre-dose and 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 24 h post-dose during the in-clinic visits) and at Visit 11
Visit 2, and at Visit 3 to Visit 10 (within 30 min pre-dose and 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 24 h post-dose during the in-clinic visits) and at Visit 11
12-lead standard ECG
Tidsramme: at Visit 1, at Visit 3 to Visit 10 (within 30 min pre-dose and 15 min, 1 h, 6 h, 24 h post-dose) and at Visit 11
at Visit 1, at Visit 3 to Visit 10 (within 30 min pre-dose and 15 min, 1 h, 6 h, 24 h post-dose) and at Visit 11
Holter-ECG
Tidsramme: At Visit 3 to Visit 10 : from 30 min pre-dose to 12 hours post-dose
At Visit 3 to Visit 10 : from 30 min pre-dose to 12 hours post-dose
Clinical laboratory tests (haematology, biochemistry, urinalysis)
Tidsramme: Visit 1 and Visit 11
Visit 1 and Visit 11
AEs
Tidsramme: From Visit 1 to Visit 11
From Visit 1 to Visit 11
Normalised AUC 0-24h of FEV1 at Day 1 of treatment period
Tidsramme: The first day of treatment period
FEV1 assessed by spirometry
The first day of treatment period
Difference between day 8 and first day of treatment period in normalised AUC 0-24h of FEV1
Tidsramme: Difference between day 8 and first day of treatement period
FEV1 assessed by spirometry
Difference between day 8 and first day of treatement period

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pierre Fabre Medicament

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2013

Primær færdiggørelse (Faktiske)

1. april 2014

Studieafslutning (Faktiske)

1. april 2014

Datoer for studieregistrering

Først indsendt

5. september 2013

Først indsendt, der opfyldte QC-kriterier

23. september 2013

Først opslået (Skøn)

26. september 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. september 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2014

Sidst verificeret

1. september 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2013-002517-35

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Jamaica

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner