Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD)
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough FEV1 Response |
0.071; 0.125; 0.136; 0.155; 0.083; 0.134 | — |
| SECONDARY Trough Forced Vital Capacity (FVC) Response |
0.114; 0.214; 0.234; 0.215; 0.122; 0.253 | — |
| SECONDARY FEV1 AUC 0-3h and FEV1 AUC 0-6h Response |
0.183; 0.258; 0.280; 0.302; 0.191; 0.288 | — |
| SECONDARY FEV1 AUC 0-3h Response After the First Dose |
0.204; 0.181; 0.209; 0.205; 0.188; 0.227 | — |
| SECONDARY FEV1 Peak 0-3h Response |
0.264; 0.353; 0.355; 0.379; 0.267; 0.374 | — |
| SECONDARY FEV1 Peak 0-3h Response After the First Dose |
0.287; 0.267; 0.300; 0.298; 0.270; 0.324 | — |
| SECONDARY FVC AUC 0-3h and FEV1 AUC 0-6h Responses |
0.278; 0.422; 0.429; 0.410; 0.279; 0.455 | — |
| SECONDARY FVC AUC 0-3h Response After First Dose |
0.333; 0.285; 0.326; 0.319; 0.303; 0.393 | — |
| SECONDARY FVC Peak 0-3h Response |
0.415; 0.570; 0.563; 0.542; 0.411; 0.585 | — |
| SECONDARY FVC Peak 0-3h Response After the First Dose |
0.473; 0.423; 0.481; 0.462; 0.436; 0.547 | — |
| SECONDARY PEF AUC 0-3h and AUC 0-6h Responses |
25.542; 44.301; 50.698; 55.346; 29.713; 48.032 | — |
| SECONDARY PEF AUC 0-3h Response After the First Dose |
30.575; 32.891; 35.053; 35.243; 31.724; 33.213 | — |
| SECONDARY PEF Peak 0-3h Response |
46.010; 64.693; 69.610; 76.108; 49.025; 66.767 | — |
| SECONDARY PEF Peak 0-3h Response After the First Dose |
52.129; 53.298; 56.565; 57.318; 51.980; 54.966 | — |
| SECONDARY Individual FEV1 Measurements at Each Time Point on Day 29 |
1.410; 1.464; 1.481; 1.491; 1.414; 1.467 | — |
| SECONDARY Individual FVC Measurements at Each Time Point on Day 29 |
2.877; 2.961; 2.996; 2.954; 2.877; 3.006 | — |
| SECONDARY Individual PEF Measurements at Each Time Point on Day 29 |
246.557; 260.901; 263.662; 269.754; 249.356; 263.134 | — |
| SECONDARY Weekly Mean Number of Puffs of Rescue Medication Used Per Day |
1.511; 1.298; 1.191; 1.446; 1.423; 1.465 | — |
| SECONDARY Physicians Global Evaluation |
4.618; 4.631; 4.484; 4.579; 4.747; 4.464 | — |
| SECONDARY Patients Global Rating |
3.357; 3.135; 2.916; 3.208; 3.262; 2.880 | — |
| SECONDARY Pulse Rate Recorded in Conjunction With Spirometry |
-2.4; -2.8; -3.1; -1.8; -2.1; -3.6 | — |
| SECONDARY Systolic and Diastolic Blood Pressure Recorded in Conjunction With Spirometry |
-7.2; -6.0; -5.6; -4.8; -3.4; -5.5 | — |
Eligibility Criteria
Inclusion criteria
- All patients must sign an informed consent
- All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) must meet the following spirometric criteria:
a post-bronchodilator forced expiratory flow in 1 second (FEV1) = =600/mm3.
- Patients with any of the following conditions:
a diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists) a diagnosis of paroxysmal tachycardia - Patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit a diagnosis of clinically relevant cardiac arrhythmia a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
- Patients who have undergone thoracotomy with pulmonary resection
- Patients being treated with the following concomitant medications:
medications that prolong the QT/QTc interval oral Beta-adrenergics oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
- Pregnant or nursing women
Data sourced from ClinicalTrials.gov (NCT01040403). 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.