A Phase 3 interventional study of Aclidinium Bromide/Formoterol Fumarate and Formoterol Fumarate in Chronic Obstructive Pulmonary Disease, sponsored by AstraZeneca. Completed at 137 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-05-11.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD).
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 590 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:
Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed dose combination (FDC), high dose twice per day
Drug: Aclidinium Bromide/Formoterol Fumarate
Inhaled formoterol fumarate 12 μg, twice per day
Drug: Formoterol Fumarate
Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg, high dose twice per day
Inhaled formoterol fumarate 12 μg, twice per day
Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE)
TEAEs were coded Version 16.0 of the Medical Dictionary for Regulatory Activities (MedDRA)
Time frame: Up to study Week 56 ± 3 days
Percentage of Patients to Experience Any Potentially Clinically Significant (PCS) Post-baseline Change in Clinical Laboratory Values for Hematology, Chemistry or Urinalysis at the End of the Study
\<0.85 x lower limit of normal (LLN) or \> 1.15 upper limit of normal (ULN) for hemoglobin, hematocrit, red blood cell, platelet, white blood cell, neutrophil and lymphocyte counts \>1.15 × ULN for eosinophil, basophil and monocyte counts \>1.15 x ULN for aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, total bilirubin, creatinine kinase, lactate dehydrogenase, blood urea nitrogen, creatinine, uric acid, total cholesterol, triglycerides \<0.85 x LLN or \>1.15 ULN for fasting glucose, calcium, phosphorus, total protein and albumin \<0.95 x LLN or \>1.05 x ULN for sodium, potassium and chloride Urinary blood, ketones or pH \<0.85 x LLN or \> 1.15 ULN
Time frame: Up to study Week 52
Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure
Systolic BP ≥180 mmHg and increase ≥20 mmHg from baseline or ≤90 mmHg and decrease ≥20 mmHg from baseline; Diastolic BP ≥105 mmHg and increase ≥15 mmHg from baseline or ≤50 mmHg and decrease ≥15 mmHg from baseline; Pulse rate ≥ 110 bpm and increase ≥ 15% from baseline or ≤ 50 bpm and decrease ≥15% from baseline
Time frame: Up to study Week 56 ± 3 days
Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline
Potentially clinically significant changes were defined as listed in the table below for QT interval, QTcB, QTcF, QRS interval, PR interval and heart rate (HR)
Time frame: Up to study Week 56 ± 3 days
The study was conducted at 127 centers in the United States The first patient was screened in September 2011 and the last patient visit was in March 2013
| Milestone | Aclidinium/Formoterol 400 μg/12 μg | Formoterol 12 μg |
|---|---|---|
| Started | 392 | 198 |
| Completed | 265 | 133 |
| Not completed | 127 | 65 |
| Withdrew: Not listed below | 7 | 6 |
| Withdrew: Copd exacerbation | 13 | 3 |
| Withdrew: Lost to follow-up | 3 | 5 |
| Withdrew: Lack of efficacy | 23 | 11 |
| Withdrew: Protocol violation | 24 | 12 |
| Withdrew: Adverse event | 26 | 13 |
| Withdrew: Withdrawal by subject | 31 | 15 |
TEAEs were coded Version 16.0 of the Medical Dictionary for Regulatory Activities (MedDRA)
| Percentage of participants | Aclidinium/Formoterol 400 μg/12 μg | Formoterol 12 μg |
|---|---|---|
| Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE) | 71.4 | 65.7 |
\<0.85 x lower limit of normal (LLN) or \> 1.15 upper limit of normal (ULN) for hemoglobin, hematocrit, red blood cell, platelet, white blood cell, neutrophil and lymphocyte counts \>1.15 × ULN for eosinophil, basophil and monocyte counts \>1.15 x ULN for aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, total bilirubin, creatinine kinase, lactate dehydrogenase, blood urea nitrogen, creatinine, uric acid, total cholesterol, triglycerides \<0.85 x LLN or \>1.15 ULN for fasting glucose, calcium, phosphorus, total protein and albumin \<0.95 x LLN or \>1.05 x ULN for sodium, potassium and chloride Urinary blood, ketones or pH \<0.85 x LLN or \> 1.15 ULN
| Percentage of participants | Aclidinium/Formoterol 400 μg/12 μg | Formoterol 12 μg |
|---|---|---|
| Percentage of Patients to Experience Any Potentially Clinically Significant (PCS) Post-baseline Change in Clinical Laboratory Values for Hematology, Chemistry or Urinalysis at the End of the Study | 63.9 | 62.1 |
Systolic BP ≥180 mmHg and increase ≥20 mmHg from baseline or ≤90 mmHg and decrease ≥20 mmHg from baseline; Diastolic BP ≥105 mmHg and increase ≥15 mmHg from baseline or ≤50 mmHg and decrease ≥15 mmHg from baseline; Pulse rate ≥ 110 bpm and increase ≥ 15% from baseline or ≤ 50 bpm and decrease ≥15% from baseline
| Percentage of patients | Aclidinium/Formoterol 400 μg/12 μg | Formoterol 12 μg |
|---|---|---|
| Systolic BP ≥180 mmHg and increase ≥20 mmHg | 0.3 | 0.5 |
| Systolic BP ≤90 mmHg and decrease ≥20 mmHg | 1.5 | 1.0 |
| Diastolic BP ≥105 mmHg and increase ≥15 mmHg | 0 | 0.5 |
| Diastolic BP ≤50 mmHg and decrease ≥15 mmHg | 0.3 | 1.0 |
| Pulse rate ≥ 110 bpm and increase ≥ 15% | 0.8 | 0.5 |
| Pulse rate ≤ 50 bpm and decrease ≥15% | 0 | 0 |
Potentially clinically significant changes were defined as listed in the table below for QT interval, QTcB, QTcF, QRS interval, PR interval and heart rate (HR)
| Percentage of patients | Aclidinium/Formoterol 400 μg/12 μg | Formoterol 12 μg |
|---|---|---|
| QT interval change from baseline >30 msec | 42.0 | 44.7 |
| QT interval >480 msec | 3.9 | 2.0 |
| QTcB change from baseline >30 msec | 31.1 | 30.3 |
| QTcB value >480 msec | 3.1 | 4.5 |
| QTcF change from baseline >30 msec | 21.5 | 22.7 |
| QTcF value >480 msec | 1.5 | 1.5 |
| QRS interval ≥100 msec and increase ≥25% from base | 2.0 | 1.0 |
| PR interval ≥200 msec and increase ≥25% from base | 2.8 | 1.0 |
| HR ≥110 bpm and decrease ≥15% from baseline | 2.6 | 1.0 |
| HR ≤50 bpm and decrease ≥15% from baseline | 4.6 | 4.0 |
Collected over Up to study Week 56 ± 3 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aclidinium/Formoterol 400 μg/12 μg | — | 38/392 (9.7%) | 164/392 (41.8%) |
| Formoterol 12 μg | — | 21/198 (10.6%) | 88/198 (44.4%) |
| Event | Aclidinium/Formoterol 400 μg/12 μg | Formoterol 12 μg |
|---|---|---|
| PneumoniaInfections and infestations | 4/392 | 1/198 |
| Abdominal painGastrointestinal disorders | 2/392 | 1/198 |
| Atrial fibrillationCardiac disorders | 2/392 | 1/198 |
| DeathGeneral disorders | 2/392 | 0/198 |
| Non-cardiac chest painGeneral disorders | 2/392 | 0/198 |
| Cardiac failure congestiveCardiac disorders | 1/392 | 1/198 |
| DiverticulitisInfections and infestations | 1/392 | 1/198 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/392 | 1/198 |
| Urinary tract infectionInfections and infestations | 1/392 | 1/198 |
| Aortic stenosisVascular disorders | 0/392 | 1/198 |
| Event | Aclidinium/Formoterol 400 μg/12 μg | Formoterol 12 μg |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 106/392 | 57/198 |
| Urinary tract infectionInfections and infestations | 26/392 | 11/198 |
| NasopharyngitisInfections and infestations | 25/392 | 9/198 |
| Upper respiratory tract infectionInfections and infestations | 18/392 | 12/198 |
| AnxietyPsychiatric disorders | 23/392 | 5/198 |
| NauseaGastrointestinal disorders | 7/392 | 11/198 |
| SinusitisInfections and infestations | 20/392 | 11/198 |
| CoughRespiratory, thoracic and mediastinal disorders | 10/392 | 10/198 |
| Age, Continuous(Years) | Aclidinium/Formoterol 400 μg/12 μg | Formoterol 12 μg | Total |
|---|---|---|---|
| Mean | 63.9 ± 9.3 | 64.7 ± 9.4 | 64.2 ± 9.4 |
| Sex: Female, Male(Participants) | Aclidinium/Formoterol 400 μg/12 μg | Formoterol 12 μg | Total |
|---|---|---|---|
| Female | 176 | 89 | 265 |
| Male | 216 | 109 | 325 |
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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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