Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Aclidinium Bromide/Formoterol Fumarate; Drug: Formoterol Fumarate

• Registration Number: NCT01437540
• Lead Sponsor: AstraZeneca

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-19
• Study First Submitted: 2011-09-19
• Study First Submitted QC: 2011-09-20
• Study First Posted: 2011-09-21
• Primary Completion: 2013-03-31
• Disposition First Submitted: 2013-04-05
• Disposition First Submitted QC: 2013-04-05
• Disposition First Posted: 2013-04-11
• Study Completion: 2013-04-30
• Results First Submitted: 2016-12-19
• Status Verified: 2017-03
• Results First Submitted QC: 2017-04-03
• Last Update Submitted: 2017-04-03
• Results First Posted: 2017-05-11
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 590

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Aclidinium Bromide/Formoterol Fumarate	Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed dose combination (FDC), high dose twice per day
2	Formoterol Fumarate	Inhaled formoterol fumarate 12 μg, twice per day

Primary Outcome Measures

Name	Time	Method
Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE)	Up to study Week 56 ± 3 days	TEAEs were coded Version 16.0 of the Medical Dictionary for Regulatory Activities (MedDRA)

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure	Up to study Week 56 ± 3 days	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 to Experience Potentially Clinically Significant Changes in ECG From Baseline	Up to study Week 56 ± 3 days	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 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	Up to study Week 52	\<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

Trial Locations

Locations (137)

Forest Investigative Site 1162; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 1493; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 1620; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 1127; 🇺🇸 Mobile, Alabama, United States

Forest Investigative Site 1613; 🇺🇸 Chandler, Arizona, United States

Forest Investigative Site 1623; 🇺🇸 Peoria, Arizona, United States

Forest Investigative Site 1582; 🇺🇸 Phoenix, Arizona, United States

Forest Investigative Site 1379; 🇺🇸 Phoenix, Arizona, United States

Forest Investigative Site 1581; 🇺🇸 Phoenix, Arizona, United States

Forest Investigative Site 1571; 🇺🇸 Phoenix, Arizona, United States

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