Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Phase 2

Terminated

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Once-daily aclidinium/formoterol; Drug: Twice-daily formoterol fumarate; Drug: Placebo to formoterol fumarate; Drug: Once-daily formoterol fumarate

• Registration Number: NCT00706914
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-26
• Study First Submitted QC: 2008-06-27
• Study Start: 2008-06-30
• Study First Posted: 2008-06-30
• Primary Completion: 2008-11-11
• Study Completion: 2008-11-11
• Disposition First Submitted: 2011-09-30
• Disposition First Submitted QC: 2011-09-30
• Disposition First Posted: 2011-10-05
• Results First Submitted: 2017-02-03
• Status Verified: 2017-04
• Results First Submitted QC: 2017-05-08
• Last Update Submitted: 2017-05-08
• Results First Posted: 2017-05-15
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• Moderate to severe COPD
• Smoking history of greater or equal to 10 pack-years
• Diagnosis of stable moderate to severe COPD as defined by the GOLD Guidelines
• Postbronchodilator FEV1 from 30% to 79% of predicted values, inclusive
• Postbronchodilator FEV1/FVC ratio < 0.70

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Exclusion Criteria

• History or presence of asthma, allergic rhinitis, or exercise-induced bronchospasm
• Hospitalization for an acute COPD exacerbation in the 3 months prior to study entry
• Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry
• Eosinophil count of at least 600 cells/mm3
• Long term oxygen therapy > 15 hours a day

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Once-daily aclidinium/formoterol	Once-daily aclidinium/formoterol	Aclidinium bromide 200 µg/ formoterol fumarate 12 µg fixed-dose combination (FDC) once-daily in the morning, plus placebo once-daily in the evening
Once-daily aclidinium/formoterol	Placebo to formoterol fumarate	Aclidinium bromide 200 µg/ formoterol fumarate 12 µg fixed-dose combination (FDC) once-daily in the morning, plus placebo once-daily in the evening
Morning aclidinium/formoterol plus evening formoterol	Once-daily aclidinium/formoterol	Aclidinium bromide 200 µg/formoterol fumarate 12 µg FDC once-daily in the morning, plus formoterol fumarate 12µg once-daily in the evening
Formoterol BID	Twice-daily formoterol fumarate	Formoterol fumarate 12 µg twice-daily (BID)
Morning aclidinium/formoterol plus evening formoterol	Once-daily 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

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Weekly Average Nocturnal Symptom Scores	Week 4 of treatment	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
Change From Baseline in Weekly Average Daily (24 Hour) Sputum Volume Scores	Week 4 of treatment	Sputum Volume Score Scale: 0 = None; 1 = The amount of one teaspoon; 2 = The amount of one tablespoon; 3 = More than one tablespoon

Trial Locations

Locations (1)

Forest Investigative Site; 🇺🇸 Milwaukee, Wisconsin, United States