The Effects of Inhaled Aclidinium Bromide/Formoterol Fumarate on Inspiratory Pleural Pressures in Smokers

NCT ID: NCT03104634

Last Updated: 2019-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2019-02-01

Brief Summary

This short-term study aims to prove the potential cardio-protective physiological effect of inhaled aclidinium bromide/formoterol fumarate on inspiratory pleural pressures.

Smoking is associated with gas-trapping (hyperinflation), even in the absence of chronic obstructive pulmonary disease. Breathing in the presence of gas-trapping requires large negative inspiratory pleural pressures, which are transmitted to the surface of the heart and increase cardiac wall stress.

Inhaled aclidinium bromide and formoterol fumarate has been shown to reduce gas-trapping, but the impact on inspiratory pleural pressures and biomarkers of cardiac stress in smokers is unknown.

Conditions

Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active arm

Aclidinium bromide/formoterol fumarate dihydrate 400 mcg/12 mcg Twice daily (once in the morning, once in the evening) 7-days

Group Type: EXPERIMENTAL

Aclidinium bromide/formoterol fumarate dihydrate

Intervention Type: DRUG

Cross-over design with washout interval. Randomized order of active and placebo arm

Placebo arm

Placebo Twice daily (once in the morning, once in the evening) 7-days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo and delivery device matched to active intervention

Interventions

Aclidinium bromide/formoterol fumarate dihydrate

Cross-over design with washout interval. Randomized order of active and placebo arm

Intervention Type: DRUG

Placebo

Placebo and delivery device matched to active intervention

Intervention Type: DRUG

Other Intervention Names

DUAKLIR™ GENUAIR®

Eligibility Criteria

Inclusion Criteria

• Current and former smokers with ≥20 pack-years of smoking history
• Gas-trapping (residual volume >110% predicted)

Exclusion Criteria

Physician-diagnosis of chronic obstructive pulmonary disease in the past 1 year and regular use of long-acting antimuscarinic (LAMA) and/or long-acting beta-agonist (LABA) (i.e., at least 30 consecutive days)

• Physician-diagnosis of asthma in the past 5 years
• Regular inhaled corticosteroid (ICS) use in the past 5 years (i.e., at least 30 consecutive days)
• Physician-diagnosis of other lung diseases (sarcoidosis, tuberculosis, cystic fibrosis, pulmonary fibrosis, lung cancer), or long-term oxygen therapy
• Respiratory tract infection within 4-weeks
• Physician-diagnosis of arrhythmia, or significant valvular disease.
• Physician-diagnosis of myocardial infarction, unstable angina or heart failure requiring unscheduled outpatient or emergency department visit within 6-months.
• Arrhythmia or prolonged corrected QT (QTc) on electrocardiogram.
• Inability to use study inhaler
• Glaucoma
• Benign prostatic hypertrophy
• Pregnancy
• Contraindications to anti-cholinergic, beta-agonist, or cardiopulmonary exercise testing with manometry
• Inability to provide written informed consent

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Benjamin McDonald Smith

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

B M Smith, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

McGill University Health Centre Research Institute

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2017-2748

Identifier Type: -

Identifier Source: org_study_id