Single Dose Ranging Study of BI 1744 CL (Olodaterol) in Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Single Dose Preliminary Dose-ranging and Safety in Patients With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809262
• Other study ID #: 1222.3
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2013
• Last updated: May 27, 2014
• Start date: December 2005
• Est. completion date: November 2006

Study information

• Verified date: May 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medicines Evaluation Board (MEB)United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion criteria:

1. Diagnosis of chronic obstructive pulmonary disease

2. Smoking history of more than 10-pack years

Exclusion criteria:

1. History of asthma, allergic rhinitis, myocardial infarction or unstable of life-threatening cardiac arrhythmias

2. Marked baseline prolongation of QT/QTc interval

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• single dose of 5 mcg
solution for inhalation
• single dose of placebo
solution for inhalation
• single dose of 40 mcg
solution for inhalation
• single dose of 20 mcg
solution for inhalation
• single dose of 2 mcg
solution for inhalation
• single dose of 10 mcg
solution for inhalation

Locations

Country	Name	City	State
Netherlands	1222.3.1 Atrium medisch centrum	Heerlen

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment	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.	24 hours post-dosing	No
Secondary	FEV1 AUC 0 - 3 Hours	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.	-10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing	No
Secondary	FEV1 AUC 0 - 12 Hours	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.	-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing	No
Secondary	FEV1 AUC 0 - 24 Hours	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.	-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing	No
Secondary	FEV1 AUC 12 - 24 Hours	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.	12h, 14h, 22h, 23h and 24h post-dosing	No
Secondary	Peak FEV1 From 0 to 3 Hours	Peak FEV1 was defined as the maximum values of FEV1 from 0 to 3 hours.	0 to 3 hours post-dosing	No
Secondary	Peak Forced Vital Capacity (FVC) From 0 to 3 Hours	Peak FVC was defined as the maximum values of FVC from 0 to 3 hours.	0 to 3 hours post-dosing	No
Secondary	Time to Peak Bronchodilator Response	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.	0 to 3 hours post-dosing	No
Secondary	Time to Onset of Response	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.	0 to 3 hours post-dosing	No
Secondary	Number of Patients Requiring Rescue Medication on a Test-day	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.	Visits 1,2,4,5,6	No
Secondary	Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG	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).	2 weeks	No
Secondary	Laboratory Testing: Average Change From Baseline of Potassium and Calcium	Laboratory testing: Average change from baseline of potassium and calcium measured on test-days	Baseline and Visit 6	No

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