Effect of Indacaterol on Inspiratory Capacity (IC)
16. februar 2016 oppdatert av: 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
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
173
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Aschaffenburg, Tyskland
- Novartis Investigative Site
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Berlin, Tyskland
- Novartis Investigative Site
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Dresden, Tyskland
- Novartis Investigative Site
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Erfurt, Tyskland
- Novartis Investigative Site
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Frankfurt am Main, Tyskland
- Novartis Investigative Site
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Fulda, Tyskland
- Novartis Investigative Site
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Geesthacht, Tyskland
- Novartis Investigative Site
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Großhansdorf, Tyskland
- Novartis Investigative Site
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Halle, Tyskland
- Novartis Investigative Site
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Hamburg, Tyskland
- Novartis Investigative Site
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Kiel, Tyskland
- Novartis Investigative Site
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Koblenz, Tyskland
- Novartis Investigative Site
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Leipzig, Tyskland
- Novartis Investigative Site
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Mannheim, Tyskland
- Novartis Investigative Site
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Marburg, Tyskland
- Novartis Investigative Site
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Neumünster, Tyskland
- Novartis Investigative Site
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Potsdam, Tyskland
- Novartis Investigative Site
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Rathenow, Tyskland
- Novartis Investigative Site
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Rüdersdorf, Tyskland
- Novartis Investigative Site
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Witten, Tyskland
- Novartis Investigator Site
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Zerbst, Tyskland
- Novartis Investigative Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Peak Inspiratory Capacity (IC) After 21 Days of Treatment
Tidsramme: 21 days
|
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.
|
21 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Trough IC After 20 Days of Treatment
Tidsramme: 20 days
|
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.
|
20 days
|
|
Peak Residual Volume (RV) After 21 Days of Treatment
Tidsramme: 21 days
|
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.
|
21 days
|
|
Peak Total Lung Capacity (TLC) After 21 Days of Treatment
Tidsramme: 21 days
|
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.
|
21 days
|
|
Peak Residual Volume/Peak Total Lung Capacity (RV/TLC) Ratio After 21 Days of Treatment
Tidsramme: 21 days
|
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.
|
21 days
|
|
Peak Specific Airway Resistance (sRaw) After 21 Days of Treatment
Tidsramme: 21 days
|
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.
|
21 days
|
|
FEV1 30 Minutes Post-dose After 21 Days of Treatment
Tidsramme: 21 days
|
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.
|
21 days
|
|
Trough Forced Expiratory Volume in 1 Second (FEV1) After 20 Days of Treatment
Tidsramme: 20 days
|
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.
|
20 days
|
Samarbeidspartnere og etterforskere
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2009
Primær fullføring (Faktiske)
1. januar 2011
Datoer for studieregistrering
Først innsendt
11. november 2009
Først innsendt som oppfylte QC-kriteriene
12. november 2009
Først lagt ut (Anslag)
13. november 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. februar 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. februar 2016
Sist bekreftet
1. februar 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Sykdommer i luftveiene
- Respirasjonsforstyrrelser
- Lungesykdommer
- Lungesykdommer, obstruktiv
- Lungesykdom, kronisk obstruktiv
- Respirasjonsaspirasjon
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Parasympatholytika
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Kolinerge antagonister
- Kolinerge midler
- Bronkodilatatorer
- Anti-astmatiske midler
- Luftveismidler
- Tiotropiumbromid
Andre studie-ID-numre
- CQAB149BDE01
- EUDRACT No.: 2009-013686-26 (Annen identifikator: EUDRACT)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .