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

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ClinicalTrials.gov Identifier: NCT01809262
Recruitment Status : Completed
First Posted : March 12, 2013
Results First Posted : June 30, 2014
Last Update Posted : June 30, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: single dose of 5 mcg Drug: single dose of placebo Drug: single dose of 40 mcg Drug: single dose of 20 mcg Drug: single dose of 2 mcg Drug: single dose of 10 mcg Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Single Dose Preliminary Dose-ranging and Safety in Patients With COPD
Study Start Date : December 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD
Drug Information available for: Olodaterol

Arm Intervention/treatment
Experimental: olodaterol 2 mcg
solution for inhalation
Drug: single dose of 2 mcg
solution for inhalation

Experimental: olodaterol 5 mcg
solution for inhalation
Drug: single dose of 5 mcg
solution for inhalation

Experimental: olodaterol 10 mcg
solution for inhalation
Drug: single dose of 10 mcg
solution for inhalation

Experimental: olodaterol 20 mcg
solution for inhalation
Drug: single dose of 20 mcg
solution for inhalation

Experimental: olodaterol 40 mcg
solution for inhalation
Drug: single dose of 40 mcg
solution for inhalation

Placebo Comparator: placebo
solution for inhalation
Drug: single dose of placebo
solution for inhalation




Primary Outcome Measures :
  1. Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment [ Time Frame: 24 hours post-dosing ]
    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.


Secondary Outcome Measures :
  1. FEV1 AUC 0 - 3 Hours [ Time Frame: -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.

  2. FEV1 AUC 0 - 12 Hours [ Time Frame: -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.

  3. FEV1 AUC 0 - 24 Hours [ Time Frame: -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.

  4. FEV1 AUC 12 - 24 Hours [ Time Frame: 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 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.

  5. Peak FEV1 From 0 to 3 Hours [ Time Frame: 0 to 3 hours post-dosing ]
    Peak FEV1 was defined as the maximum values of FEV1 from 0 to 3 hours.

  6. Peak Forced Vital Capacity (FVC) From 0 to 3 Hours [ Time Frame: 0 to 3 hours post-dosing ]
    Peak FVC was defined as the maximum values of FVC from 0 to 3 hours.

  7. Time to Peak Bronchodilator Response [ Time Frame: 0 to 3 hours post-dosing ]
    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.

  8. Time to Onset of Response [ Time Frame: 0 to 3 hours post-dosing ]
    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.

  9. Number of Patients Requiring Rescue Medication on a Test-day [ Time Frame: Visits 1,2,4,5,6 ]
    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.

  10. Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG [ Time Frame: 2 weeks ]
    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).

  11. Laboratory Testing: Average Change From Baseline of Potassium and Calcium [ Time Frame: Baseline and Visit 6 ]
    Laboratory testing: Average change from baseline of potassium and calcium measured on test-days



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809262


Locations
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Netherlands
1222.3.1 Atrium medisch centrum
Heerlen, Netherlands
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01809262     History of Changes
Other Study ID Numbers: 1222.3
First Posted: March 12, 2013    Key Record Dates
Results First Posted: June 30, 2014
Last Update Posted: June 30, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Pharmaceutical Solutions
Olodaterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents