A Phase 2 interventional study of Once-daily aclidinium/formoterol and Twice-daily formoterol fumarate in Pulmonary Disease, Chronic Obstructive, sponsored by AstraZeneca. Terminated at 40 sites in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-05-15.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the evening vs. the FDC once daily in the morning and formoterol fumarate once in the evening vs. formoterol fumarate twice daily. The study will assess pulmonary function and symptoms in patients with moderate to severe COPD.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 156 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
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Exclusion Criteria:
Aclidinium bromide 200 µg/ formoterol fumarate 12 µg fixed-dose combination (FDC) once-daily in the morning, plus placebo once-daily in the evening
Drug: Once-daily aclidinium/formoterol · Drug: Placebo to formoterol fumarate
Aclidinium bromide 200 µg/formoterol fumarate 12 µg FDC once-daily in the morning, plus formoterol fumarate 12µg once-daily in the evening
Drug: Once-daily aclidinium/formoterol · Drug: Once-daily formoterol fumarate
Formoterol fumarate 12 µg twice-daily (BID)
Drug: Twice-daily formoterol fumarate
Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning
Inhaled formoterol fumarate 12 µg twice-daily (BID)
Inhaled placebo to formoterol fumarate once-daily in the evening
Inhaled formoterol fumarate 12 μg once-daily in the evening
Change From Baseline in Weekly Average Nocturnal Symptom Scores
Nocturnal Symptom Score Scale: 0 = None; 1 = Symptoms causing early awakening or awakening once during the night; 2 = Symptoms causing early awakening or awakening two or more times during the night; 3 = Symptoms causing awakening for most time during the night, 4 = Symptoms which were so severe that I could not sleep at all
Time frame: Week 4 of treatment
Change From Baseline in Weekly Average Daily (24 Hour) Sputum Volume Scores
Sputum Volume Score Scale: 0 = None; 1 = The amount of one teaspoon; 2 = The amount of one tablespoon; 3 = More than one tablespoon
Time frame: Week 4 of treatment
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)
The trough value for each pulmonary function parameter was defined as the mean of the two greatest readings assessed 23 hours and 24 hours following the administration of the morning dose of the previous day
Time frame: Week 4 of treatment
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
Time frame: Week 4 of treatment
Change From Baseline in Normalized Area Under the Curve (0-3 hr) of Forced Expiratory Volume in One Second (FEV1)
FEV1 values obtained at 30, 60, 120, and 180 minutes after the morning study drug dose
Time frame: Week 4 of treatment
This study was conducted in 31 sites in the United States (US). All sites screened at least one patient and, of these 31 sites, three sites did not enroll any patients. The first patient was screened in March 2008 and the last patient visit was in February 2009.
| Milestone | Once-daily Aclidinium/Formoterol | Morning Aclidinium/Formoterol Plus Evening Formoterol | Formoterol BID |
|---|---|---|---|
| Started | 63 | 62 | 31 |
| Completed | 57 | 58 | 30 |
| Not completed | 6 | 4 | 1 |
| Withdrew: Lack of efficacy | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
| Withdrew: Adverse event | 2 | 2 | 0 |
| Withdrew: Protocol violation | 3 | 1 | 1 |
Nocturnal Symptom Score Scale: 0 = None; 1 = Symptoms causing early awakening or awakening once during the night; 2 = Symptoms causing early awakening or awakening two or more times during the night; 3 = Symptoms causing awakening for most time during the night, 4 = Symptoms which were so severe that I could not sleep at all
| Units on a scale | Once-daily Aclidinium/Formoterol | Morning Aclidinium/Formoterol Plus Evening Formoterol | Formoterol BID |
|---|---|---|---|
| Change From Baseline in Weekly Average Nocturnal Symptom Scores | -0.15 (-0.33 to 0.04) | -0.09 (-0.26 to 0.08) | -0.35 (-0.59 to -0.12) |
Sputum Volume Score Scale: 0 = None; 1 = The amount of one teaspoon; 2 = The amount of one tablespoon; 3 = More than one tablespoon
| Units on a scale | Once-daily Aclidinium/Formoterol | Morning Aclidinium/Formoterol Plus Evening Formoterol | Formoterol BID |
|---|---|---|---|
| Change From Baseline in Weekly Average Daily (24 Hour) Sputum Volume Scores | -0.17 (-0.34 to -0.01) | 0.13 (-0.07 to 0.32) | -0.00 (-0.20 to 0.20) |
The trough value for each pulmonary function parameter was defined as the mean of the two greatest readings assessed 23 hours and 24 hours following the administration of the morning dose of the previous day
| Liters | Once-daily Aclidinium/Formoterol | Morning Aclidinium/Formoterol Plus Evening Formoterol | Formoterol BID |
|---|---|---|---|
| Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) | 0.097 (0.059 to 0.135) | 0.084 (0.040 to 0.128) | 0.118 (0.070 to 0.166) |
| Liters | Once-daily Aclidinium/Formoterol | Morning Aclidinium/Formoterol Plus Evening Formoterol | Formoterol BID |
|---|---|---|---|
| Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) | 0.355 (0.308 to 0.403) | 0.319 (0.265 to 0.373) | 0.280 (0.220 to 0.341) |
FEV1 values obtained at 30, 60, 120, and 180 minutes after the morning study drug dose
| Liters | Once-daily Aclidinium/Formoterol | Morning Aclidinium/Formoterol Plus Evening Formoterol | Formoterol BID |
|---|---|---|---|
| Change From Baseline in Normalized Area Under the Curve (0-3 hr) of Forced Expiratory Volume in One Second (FEV1) | 0.257 (0.211 to 0.302) | 0.226 (0.176 to 0.276) | 0.200 (0.142 to 0.258) |
Collected over 29 ± 2 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Once-daily Aclidinium/Formoterol | — | 1/63 (1.6%) | 0/63 (0%) |
| Morning Aclidinium/Formoterol Plus Evening Formoterol | — | 1/62 (1.6%) | 0/62 (0%) |
| Formoterol BID | — | 0/31 (0%) | 2/31 (6.5%) |
| Event | Once-daily Aclidinium/Formoterol | Morning Aclidinium/Formoterol Plus Evening Formoterol | Formoterol BID |
|---|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 0/63 | 1/62 | 0/31 |
| Drug withdrawal convulsionsNervous system disorders | 1/63 | 0/62 | 0/31 |
| Event | Once-daily Aclidinium/Formoterol | Morning Aclidinium/Formoterol Plus Evening Formoterol | Formoterol BID |
|---|---|---|---|
| NauseaGastrointestinal disorders | 0/63 | 0/62 | 2/31 |
| Age, Continuous(Years) | Once-daily Aclidinium/Formoterol | Morning Aclidinium/Formoterol Plus Evening Formoterol | Formoterol BID | Total |
|---|---|---|---|---|
| Mean | 63.0 ± 7.2 | 63.9 ± 9.0 | 62.2 ± 10.1 | 63.2 ± 8.5 |
| Sex: Female, Male(Participants) | Once-daily Aclidinium/Formoterol | Morning Aclidinium/Formoterol Plus Evening Formoterol | Formoterol BID | Total |
|---|---|---|---|---|
| Female | 28 | 25 | 15 | 68 |
| Male | 35 | 37 | 16 | 88 |
This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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