Phase 2
Completed N=36
Single Dose Ranging Study of BI 1744 CL (Olodaterol) in Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01809262 ↗
Enrolled (actual)
36
Serious AEs
2.3%
Results posted
Jun 2014
Primary outcomePrimary: Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment — 0.916; 0.986; 1.015; 1.029 L — p=0.0005
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment |
0.916; 0.986; 1.015; 1.029; 1.035 | 0.0005 sig |
| SECONDARY FEV1 AUC 0 - 3 Hours |
0.997; 1.105; 1.152; 1.158; 1.189 | <0.0001 sig |
| SECONDARY FEV1 AUC 0 - 12 Hours |
0.954; 1.053; 1.093; 1.108; 1.138 | <0.0001 sig |
| SECONDARY FEV1 AUC 0 - 24 Hours |
0.923; 1.009; 1.040; 1.061; 1.085 | <0.0001 sig |
| SECONDARY FEV1 AUC 12 - 24 Hours |
0.891; 0.965; 0.987; 1.014; 1.032 | <0.0001 sig |
| SECONDARY Peak FEV1 From 0 to 3 Hours |
1.043; 1.164; 1.209; 1.219; 1.256 | <0.0001 sig |
| SECONDARY Peak Forced Vital Capacity (FVC) From 0 to 3 Hours |
3.134; 3.440; 3.489; 3.485; 3.589 | <0.0001 sig |
| SECONDARY Time to Peak Bronchodilator Response |
102.0; 92.6; 98.6; 83.8; 96.9 | — |
| SECONDARY Time to Onset of Response |
148.9; 91.5; 57.5; 59.9; 38.2 | — |
| SECONDARY Number of Patients Requiring Rescue Medication on a Test-day |
4; 4; 0; 1; 1 | — |
| SECONDARY Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG |
0; 0; 0; 0; 0; 0.0 | — |
| SECONDARY Laboratory Testing: Average Change From Baseline of Potassium and Calcium |
1.03; 1.01; 0.99; 0.98; 0.97; 1.02 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01809262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.