Single Dose Ranging Study of BI 1744 CL (Olodaterol) in Chronic Obstructive Pulmonary Disease
27 maj 2014 uppdaterad av: Boehringer Ingelheim
Single Dose Preliminary Dose-ranging and Safety in Patients With COPD
Primary objective: To investigate bronchodilator effect and safety of single doses of BI 1744 CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics of BI 1744 CL.
Olodaterol dose 40 mcg was investigated only in the open-label extension part for additional PK assessments which are not defined as primary or secondary endpoints.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
36
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
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Heerlen, Nederländerna
- 1222.3.1 Atrium medisch centrum
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion criteria:
- Diagnosis of chronic obstructive pulmonary disease
- Smoking history of more than 10-pack years
Exclusion criteria:
- History of asthma, allergic rhinitis, myocardial infarction or unstable of life-threatening cardiac arrhythmias
- Marked baseline prolongation of QT/QTc interval
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: olodaterol 2 mcg
solution for inhalation
|
solution for inhalation
|
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Experimentell: olodaterol 5 mcg
solution for inhalation
|
solution for inhalation
|
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Experimentell: olodaterol 10 mcg
solution for inhalation
|
solution for inhalation
|
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Experimentell: olodaterol 20 mcg
solution for inhalation
|
solution for inhalation
|
|
Experimentell: olodaterol 40 mcg
solution for inhalation
|
solution for inhalation
|
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Placebo-jämförare: placebo
solution for inhalation
|
solution for inhalation
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment
Tidsram: 24 hours post-dosing
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Forced expiratory volume in one second (FEV1) at 24 hours after a single-dose of study treatment.
Means are adjusted with test-day baseline, patient, treatment, and period as fixed effects.
Test-day baseline value was defined as the value at 10 minutes before inhalation of study medication.
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24 hours post-dosing
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
FEV1 AUC 0 - 3 Hours
Tidsram: -10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing
|
The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 3 hours, using the trapezoidal rule divided by 3 hours to give the results in litres.
The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
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-10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing
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FEV1 AUC 0 - 12 Hours
Tidsram: -10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing
|
The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 12 hours, using the trapezoidal rule divided by 12 hours to give the results in litres.
The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
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-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing
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FEV1 AUC 0 - 24 Hours
Tidsram: -10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing
|
The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 24 hours, using the trapezoidal rule divided by 24 hours to give the results in litres.
The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
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-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing
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FEV1 AUC 12 - 24 Hours
Tidsram: 12h, 14h, 22h, 23h and 24h post-dosing
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The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from 12 hours to 24 hours, using the trapezoidal rule divided by 12 hours to give the results in litres.
The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
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12h, 14h, 22h, 23h and 24h post-dosing
|
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Peak FEV1 From 0 to 3 Hours
Tidsram: 0 to 3 hours post-dosing
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Peak FEV1 was defined as the maximum values of FEV1 from 0 to 3 hours.
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0 to 3 hours post-dosing
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Peak Forced Vital Capacity (FVC) From 0 to 3 Hours
Tidsram: 0 to 3 hours post-dosing
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Peak FVC was defined as the maximum values of FVC from 0 to 3 hours.
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0 to 3 hours post-dosing
|
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Time to Peak Bronchodilator Response
Tidsram: 0 to 3 hours post-dosing
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A bronchodilator response was considered to have been achieved if an FEV1 measurement of at least 12% greater than the test-day baseline value was recorded at any time during the first 3 hours of observation after dosing.
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0 to 3 hours post-dosing
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Time to Onset of Response
Tidsram: 0 to 3 hours post-dosing
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Onset of the bronchodilator response after a single dose of study treatment was defined as the linear interpolation of the time of the first bronchodilator response and the time of the observation just prior to the first bronchodilator response (even if that is the baseline observation).
If none of the FEV1 values in the first 3 hours after dosing exceeded 12% of the pre-dose value, then the onset was set to 3 hours plus 1 minute.
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0 to 3 hours post-dosing
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Number of Patients Requiring Rescue Medication on a Test-day
Tidsram: Visits 1,2,4,5,6
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Number of Patients Requiring Rescue Medication on a Test-day.
Salbutamol inhalation aerosol MDI (Ventolin®, 100 μg/actuation) was provided for use as rescue medication.
Administration of rescue medication can occur at any point during the pulmonary function testing as deemed necessary by the patient or the investigator.
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Visits 1,2,4,5,6
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Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Tidsram: 2 weeks
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Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG.
New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).
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2 weeks
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Laboratory Testing: Average Change From Baseline of Potassium and Calcium
Tidsram: Baseline and Visit 6
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Laboratory testing: Average change from baseline of potassium and calcium measured on test-days
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Baseline and Visit 6
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Användbara länkar
Studieavstämningsdatum
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Studera stora datum
Studiestart
1 december 2005
Primärt slutförande (Faktisk)
1 november 2006
Avslutad studie (Faktisk)
1 november 2006
Studieregistreringsdatum
Först inskickad
8 mars 2013
Först inskickad som uppfyllde QC-kriterierna
8 mars 2013
Första postat (Uppskatta)
12 mars 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
30 juni 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 maj 2014
Senast verifierad
1 maj 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1222.3
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