Phase 4
Completed N=234
Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT00424528 ↗Enrolled (actual)
234
Serious AEs
—
Results posted
Apr 2009
Primary outcomePrimary: Time-normalized Area Under the Change From Study Baseline Curve for Forced Expiratory Volume in One Second (FEV1) Over 24 Hours (nAUC0-24B) — 0.104; 0.080; 0.221 Liters — p=<0.001
Summary
The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects with Chronic Obstructive Pulmonary Disease (COPD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-normalized Area Under the Change From Study Baseline Curve for Forced Expiratory Volume in One Second (FEV1) Over 24 Hours (nAUC0-24B) |
0.104; 0.080; 0.221 | <0.001 sig |
| SECONDARY Time-normalized Area From Study Baseline Curve for FEV1 Over 0-12 Hours (nAUC0-12B) |
0.118; 0.130; 0.242 | <0.001 sig |
| SECONDARY Time Normalized Area Under the Change From Study Baseline Curve for FEV1 Over 12-24 Hours (nAUC12-24B) |
0.094; 0.054; 0.217 | 0.001 sig |
| SECONDARY Change in FEV1 From Study Baseline to the 24-hour Timepoint (Trough) |
0.086; 0.080; 0.154 | 0.073 |
| SECONDARY Change in FEV1 From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication |
0.132; -0.20; 0.139; 0.163; 0.056; 0.183 | — |
| SECONDARY Change in FEV1 Percent of Predicted From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication |
4.3; -0.6; 4.7; 5.5; 2.0; 6.1 | — |
| SECONDARY Peak Change in FEV1 Over 12 Hours Post Dose From Study Baseline |
0.264; 0.218; 0.311; 0.273; 0.265; 0.379 | 0.060 |
| SECONDARY Time to Onset in Participants Who Achieved a 10% Increase in FEV1 From Visit Predose After 2 Weeks |
0.39; 0.72; 0.17 | — |
| SECONDARY Time to Onset in Participants Who Achieved a 15% Increase in FEV1 From Visit Predose After 2 Weeks |
0.76; 1.29; 0.39 | — |
| SECONDARY Change in Inspiratory Capacity From Study Baseline to the 24 Hour Timepoint (Trough) Following 2 Weeks of Dosing |
0.074; 0.023; 0.150 | 0.206 |
| SECONDARY Change in Forced Vital Capacity (FVC) From Study Baseline at Each Assessed Post Dose Timepoint |
0.276; -0.031; 0.259; 0.312; 0.122; 0.323 | — |
| SECONDARY Levalbuterol Metered Dose Inhaler (MDI) (Rescue Medication) Use in Days Per Week |
4.44; 4.27; 4.57; 2.16; 1.94; 1.38 | — |
| SECONDARY Levalbuterol Metered Dose Inhaler (MDI) Rescue Medication Use in Actuations Per Day |
3.24; 2.77; 3.08; 1.18; 1.00; 0.68 | — |
| SECONDARY Transition Dyspnea Index (TDI) Focal Score |
2.28; 1.79; 3.13 | — |
| SECONDARY Number of Participants With a >= 1 Unit of Improvement in the TDI Focal Score |
50; 44; 60 | — |
| SECONDARY Percentage of Participants With a >=1 Unit Improvement in Transition Dysnea Index (TDI) Focal Score |
66.67; 57.14; 77.92 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female subjects must be at least 45 years old at the time of consent.
- Subjects must have a pre-established primary clinical diagnosis of COPD.
- Subjects must have a baseline FEV1 of ≤65% of predicted normal value at Visit 1.
- Subjects must have a FEV1 ≥ 0.70L at Visit 1.
Exclusion Criteria
- Subjects who do not have a FEV1/forced vital capacity (FVC) ratio of ≤70% at Visit 1.
- Subjects who do not have a ³15 pack-year smoking history and a baseline breathlessness severity grade of ³2 (Modified Medical Research Council [MMRC] Dyspnea Scale Score) at Visit 1.
Data sourced from ClinicalTrials.gov (NCT00424528). 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.