Phase 3
Completed N=590
Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov NCT01437540 ↗Enrolled (actual)
590
Serious AEs
10.0%
Results posted
May 2017
Primary outcomePrimary: Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE) — 71.4; 65.7 Percentage of participants
◆ Published Evidence
Established
30citations · ~3 / year
Long-term safety of aclidinium bromide/formoterol fumarate fixed-dose combination: Results of a randomized 1-year trial in patients with COPD.
Summary
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).
Linked Publications
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Long-term safety of aclidinium bromide/formoterol fumarate fixed-dose combination: Results of a randomized 1-year trial in patients with COPD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE) |
71.4; 65.7 | — |
| SECONDARY 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 | — |
| SECONDARY Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure |
0.3; 0.5; 1.5; 1.0; 0; 0.5 | — |
| SECONDARY Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline |
42.0; 44.7; 3.9; 2.0; 31.1; 30.3 | — |
Eligibility Criteria
Inclusion Criteria
- Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years
- A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway obstruction.
Exclusion Criteria
- Patients who have been hospitalized for an acute COPD exacerbation within three months prior to Visit 1
- Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Visit 1.
- Patients with any clinically significant respiratory conditions other than COPD
- Clinical history that suggests that the patient has asthma as opposed to COPD
- Chronic use of oxygen therapy ≥ 15 hours/day
- Patients with clinically significant cardiovascular conditions
- Patients with uncontrolled infection that may place the patient at risk resulting from human immunodeficiency virus (HIV), active hepatitis and/or patients with diagnosed active tuberculosis
- Patients with a history of hypersensitivity reaction to inhaled anticholinergics,
- Patients with Stage II hypertension, defined as systolic pressure of 160 and above, and/or diastolic pressure of 100 and above
- Current diagnosis of cancer other than basal or squamous cell skin cancer
Data sourced from ClinicalTrials.gov (NCT01437540) and the linked publication. 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.