Effect of Indacaterol on Inspiratory Capacity (IC)
tiistai 16. helmikuuta 2016 päivittänyt: Novartis Pharmaceuticals
A Randomized, Double-blind, Placebo Controlled, Multicenter, 3-period Crossover Study to Compare the Effect of Indacaterol (150μg o.d.) on Inspiratory Capacity to Placebo in Patients With Moderate COPD, Using Open Label Tiotropium (18μg o.d.) as Active Control
This study is being conducted to assess the effect of indacaterol (150 μg o.d.) on inspiratory capacity (IC), using placebo and open label tiotropium (18 μg o.d.) as comparators in patients with moderate chronic obstructive pulmonary disease (COPD).
In particular, spirometric timepoints are included to elucidate the peak-IC in a period of approximately 4 hour post inhalation
Tutkimuksen yleiskatsaus
Tila
Valmis
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
173
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Aschaffenburg, Saksa
- Novartis Investigative Site
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Berlin, Saksa
- Novartis Investigative Site
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Dresden, Saksa
- Novartis Investigative Site
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Erfurt, Saksa
- Novartis Investigative Site
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Frankfurt am Main, Saksa
- Novartis Investigative Site
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Fulda, Saksa
- Novartis Investigative Site
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Geesthacht, Saksa
- Novartis Investigative Site
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Großhansdorf, Saksa
- Novartis Investigative Site
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Halle, Saksa
- Novartis Investigative Site
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Hamburg, Saksa
- Novartis Investigative Site
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Kiel, Saksa
- Novartis Investigative Site
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Koblenz, Saksa
- Novartis Investigative Site
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Leipzig, Saksa
- Novartis Investigative Site
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Mannheim, Saksa
- Novartis Investigative Site
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Marburg, Saksa
- Novartis Investigative Site
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Neumünster, Saksa
- Novartis Investigative Site
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Potsdam, Saksa
- Novartis Investigative Site
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Rathenow, Saksa
- Novartis Investigative Site
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Rüdersdorf, Saksa
- Novartis Investigative Site
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Witten, Saksa
- Novartis Investigator Site
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Zerbst, Saksa
- Novartis Investigative Site
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
40 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
Inclusion Criteria:
Co-operative outpatients with a diagnosis of COPD (moderate as classified by the GOLD Guidelines, 2008) and including:
- Smoking history of at least 10 pack years
- Post-bronchodilator FEV1 <80% and ≥50% of the predicted normal value (Visit 2).
- Post-bronchodilator FEV1/forced vital capacity (FVC) <70% (Visit 2).
Exclusion Criteria:
- Patients who received any corticosteroid (including inhaled) for 3 months prior to screening
Other protocol-defined inclusion/exclusion criteria may apply
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Indacaterol - placebo - tiotropium
In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received tiotropium 18µg once daily.
Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device.
There was a washout period of 13 days between each period.
Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued.
Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Tiotropium 18µg o.d.
delivered via a proprietary inhalation device.
Placebo to indacaterol o.d.
delivered via SDDPI
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Kokeellinen: Placebo - Tiotropium - Indacaterol
In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received tiotropium 18µg once daily; in treatment period 3, patients received indacaterol 150µg once daily.
Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device.
There was a washout period of 13 days between each period.
Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued.
Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Tiotropium 18µg o.d.
delivered via a proprietary inhalation device.
Placebo to indacaterol o.d.
delivered via SDDPI
|
|
Kokeellinen: Tiotropium - indacaterol - placebo
In treatment period 1, patients received tiotropium 18µg once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received placebo to indacaterol once daily.
Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device.
There was a washout period of 13 days between each period.
Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued.
Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Tiotropium 18µg o.d.
delivered via a proprietary inhalation device.
Placebo to indacaterol o.d.
delivered via SDDPI
|
|
Kokeellinen: Placebo - indacaterol - tiotropium
In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received tiotropium 18µg once daily.
Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device.
There was a washout period of 13 days between each period.
Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued.
Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Tiotropium 18µg o.d.
delivered via a proprietary inhalation device.
Placebo to indacaterol o.d.
delivered via SDDPI
|
|
Kokeellinen: Indacaterol - tiotropium - placebo
In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received tiotropium 18µg once daily; in treatment period 3, patients received placebo to indacaterol once daily.
Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device.
There was a washout period of 13 days between each period.
Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued.
Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Tiotropium 18µg o.d.
delivered via a proprietary inhalation device.
Placebo to indacaterol o.d.
delivered via SDDPI
|
|
Kokeellinen: Tiotropium - placebo - indacaterol
In treatment period 1, patients received tiotropium 18µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received indacaterol 150µg once daily.
Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device.
There was a washout period of 13 days between each period.
Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued.
Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Tiotropium 18µg o.d.
delivered via a proprietary inhalation device.
Placebo to indacaterol o.d.
delivered via SDDPI
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Peak Inspiratory Capacity (IC) After 21 Days of Treatment
Aikaikkuna: 21 days
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IC was measured with spirometry conducted according to internationally accepted standards.
Peak IC was defined as the maximum IC of the mean over the 3 values which were measured each at 30min, 2 hour, 3 hour and 4 hour post dose by body plethysmography.
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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21 days
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Trough IC After 20 Days of Treatment
Aikaikkuna: 20 days
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Trough IC was measured with spirometry conducted according to internationally accepted standards.
Trough IC was calculated as the mean of the three measurements of pre-dose body plethysmography (days 21, 55 and 89).
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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20 days
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Peak Residual Volume (RV) After 21 Days of Treatment
Aikaikkuna: 21 days
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Peak RV was measured with spirometry conducted according to internationally accepted standards.
Peak RV was calculated as the Total Lung Capacity minus the maximum of the three Inspiratory Vital Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89).
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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21 days
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Peak Total Lung Capacity (TLC) After 21 Days of Treatment
Aikaikkuna: 21 days
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TLC was measured with spirometry conducted according to internationally accepted standards.
Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89).
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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21 days
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Peak Residual Volume/Peak Total Lung Capacity (RV/TLC) Ratio After 21 Days of Treatment
Aikaikkuna: 21 days
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Peak RV/TLC ratio was measured with spirometry conducted according to internationally accepted standards.
Peak RV/TLC was defined as the peak RV/peak TLC.
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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21 days
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Peak Specific Airway Resistance (sRaw) After 21 Days of Treatment
Aikaikkuna: 21 days
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Peak sRaw was measured with spirometry conducted according to internationally accepted standards.
Peak sRaw was the mean of the three measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89).
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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21 days
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FEV1 30 Minutes Post-dose After 21 Days of Treatment
Aikaikkuna: 21 days
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FEV1 was measured with spirometry conducted according to internationally accepted standards.
FEV1 was measured 30 minutes post-dose.
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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21 days
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Trough Forced Expiratory Volume in 1 Second (FEV1) After 20 Days of Treatment
Aikaikkuna: 20 days
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FEV1 was measured with spirometry conducted according to internationally accepted standards.
FEV1 was measured pre-dose after 20 days of treatment.
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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20 days
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Opintojen ennätyspäivät
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Opi tärkeimmät päivämäärät
Opiskelun aloitus
Sunnuntai 1. marraskuuta 2009
Ensisijainen valmistuminen (Todellinen)
Lauantai 1. tammikuuta 2011
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 11. marraskuuta 2009
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 12. marraskuuta 2009
Ensimmäinen Lähetetty (Arvio)
Perjantai 13. marraskuuta 2009
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Keskiviikko 17. helmikuuta 2016
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 16. helmikuuta 2016
Viimeksi vahvistettu
Maanantai 1. helmikuuta 2016
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Patologiset prosessit
- Hengityselinten sairaudet
- Hengityshäiriöt
- Keuhkosairaudet
- Keuhkosairaudet, obstruktiiviset
- Keuhkosairaus, krooninen obstruktiivinen
- Hengityshengitys
- Huumeiden fysiologiset vaikutukset
- Neurotransmitterit
- Farmakologisen vaikutuksen molekyylimekanismit
- Parasympatolyytit
- Autonomiset agentit
- Ääreishermoston aineet
- Kolinergiset antagonistit
- Kolinergiset aineet
- Keuhkoputkia laajentavat aineet
- Astmaattiset aineet
- Hengityselinten aineet
- Tiotropiumbromidi
Muut tutkimustunnusnumerot
- CQAB149BDE01
- EUDRACT No.: 2009-013686-26 (Muu tunniste: EUDRACT)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
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