Phase 4
Completed N=33
Efficacy Safety Study of Arformoterol QD Dosing Versus BID Dosing in COPD
Source: ClinicalTrials.gov NCT00571428 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jul 2009
Primary outcomePrimary: Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 24 Hours — 0.156; 0.173 liters
Summary
To evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4mL QD (two 15μg/2mL dosed in combination) over a 24-hour period compared to arformoterol tartrate inhalation solution 15μg/2 mL BID in subjects with COPD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 24 Hours |
0.156; 0.173 | — |
| SECONDARY Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 12 Hours |
0.148; 0.214 | — |
| SECONDARY Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Between 12-24 Hours |
0.179; 0.132 | — |
| SECONDARY Change in Forced Expiratory Volume in One Second From Pre-dose to the 24 Hour Time Point |
0.144; 0.120 | — |
| SECONDARY Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose |
1.184; 1.179; 1.332; 1.358; 1.349; 1.384 | — |
| SECONDARY Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose |
0.148; 0.187; 0.168; 0.211; 0.179; 0.229 | — |
| SECONDARY Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose |
40.717; 40.784; 45.504; 46.396; 45.990; 47.303 | — |
| SECONDARY Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose |
4.787; 6.028; 5.574; 6.917; 5.980; 7.437 | — |
| SECONDARY Peak Percent of Predicted Forced Expiratory Volume at One Second (FEV1) Over 12 Hours Post-Dose. |
49.399; 51.251 | — |
| SECONDARY Peak Change in Forced Expiratory Volume at One Second (FEV1) Within 12 Hours Post Dose Compared to Pre-dose |
0.269; 0.324 | — |
| SECONDARY Time to Onset of 15 Percent Response Within 12 Hours of Dosing |
7.75; 2.43 | — |
| SECONDARY Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase Within 12 Hours of Dosing |
12.62; 2.86 | — |
| SECONDARY Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing |
2.545; 2.601; 2.838; 2.905; 2.903; 2.953 | — |
| SECONDARY Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point |
0.293; 0.290; 0.334; 0.340; 0.352; 0.390 | — |
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.
- Subjects must have a FEV1/forced vital capacity (FVC) ratio of ≤ 70% at Visit 1.
Exclusion Criteria
- Subjects who do not have a 15 pack-year smoking history and a baseline breathlessness severity grade of 2 (as measured by the Modified Medical Research Council [MMRC] Dyspnea Scale Score) at Screening.
- Subjects with life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to Visit
Data sourced from ClinicalTrials.gov (NCT00571428). 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.