COPD Clinical Trial
Official title:
Effect of Aclidinium Bromide/Formoterol on Nighttime Lung Function, Respiratory Mechanics and Early Morning Symptoms in Chronic Obstructive Pulmonary Disease (COPD)
Verified date | July 2019 |
Source | Queen's University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A number of studies have documented poor sleep quality and troublesome symptoms (breathlessness, cough and sputum production) upon awakening in patients with COPD. However, the investigators know very little about measurements of respiratory mechanics (i.e., lung volumes, respiratory pressures, diaphragm function, etc) during sleep in these patients. The investigators also know little about how modern bronchodilator therapies, or the timing of when they are taken, affect respiratory mechanics during sleep or the severity of early morning respiratory symptoms. COPD is often treated with inhaled bronchodilator medications which are used to open up airways and make it easier for air to get in and out of the lungs. The investigators are studying the effects of a new inhaler that contains two different types of long-acting bronchodilator: formoterol [a long-acting beta2-agonist (LABA)] and aclidinium bromide [a long-acting muscarinic antagonist (LAMA) or anticholinergic]. Initial studies have shown that this combination therapy taken twice daily can improve some lung function measurements and respiratory symptoms in patients with moderate to severe COPD. There are also reports that evening administration of this medication may provide important advantages in patients with dominant nighttime and early morning symptoms. It is thought that sustained bronchodilation and lung deflation during the night may improve respiratory mechanics, diaphragmatic function, pulmonary gas exchange, sleep quality, and reduce severity of morning symptoms. This study will be the first to explore the effects of a nighttime dose of aclidinium/formoterol combination therapy on detailed measurements of respiratory mechanics and early morning symptoms in COPD. This study will also give us a better understanding of the mechanisms of early morning respiratory symptoms and their improvement with bronchodilators.
Status | Completed |
Enrollment | 40 |
Est. completion date | August 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Moderate to severe COPD (post-bronchodilator forced expiratory volume in 1 s (FEV1) 30-79%predicted); - Resting functional residual capacity (FRC) >120% predicted; - Clinically stable and on stable triple therapy with an ICS/LABA and tiotropium; - Symptomatic: Baseline Dyspnea Index =8 and answer "in the morning" when asked about what time of day their COPD symptoms are worst. Exclusion Criteria: - A diagnosis of sleep disordered breathing; - Nocturnal oxygen therapy. |
Country | Name | City | State |
---|---|---|---|
Canada | Respiratory Investigation Unit, Kingston General Hospital | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Queen's University | AstraZeneca |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morning trough inspiratory capacity (IC) as measured by a spirometer | Early morning IC (~6:00am) will be measured to assess improvements in lung hyperinflation in response to the evening dose (~8:00pm) of a twice-daily bronchodilator vs. placebo. | 10 hours after the evening dose of randomized study drug | |
Secondary | Early Morning Symptoms of COPD Instrument (EMSCI) | Upon awakening in the morning: 10 hours after the evening dose of randomized study drug | ||
Secondary | Distribution of sleep stages obtained during polysomnography | Participants will be followed for the duration of the night after the evening dose of randomized study medication: between bedtime at 10pm and upon waking or 5:45am, whichever is sooner | ||
Secondary | Changes in the forced expired volume in 1 second (FEV1) as measured by a spirometer | Measurements will be collected at 2-hr intervals after the evening dose of randomized study medication (i.e., 2, 4, 6, 8 and 10 hrs post-dose) | ||
Secondary | Changes in IC as measured by a spirometer | Measurements will be collected at 2-hr intervals after the evening dose of randomized study medication (i.e., 2, 4, 6, 8 and 10 hrs post-dose) | ||
Secondary | Morning trough functional residual capacity (FRC) as measured by body plethysmography | For assessment of lung hyperinflation | 10 hours after the evening dose of randomized study drug | |
Secondary | Diaphragm electromyography (EMGdi) | A combined electrode-balloon esophageal/gastric catheter will be inserted nasally to measure EMGdi and respiratory pressures (esophageal and gastric pressures) | Measurements will be collected at 2-hr intervals after the evening dose of randomized study medication (i.e., 2, 4, 6, 8 and 10 hrs post-dose) | |
Secondary | Transdiaphragmatic pressure (Pdi) | A combined electrode-balloon esophageal/gastric catheter will be inserted nasally to measure EMGdi and respiratory pressures (esophageal and gastric pressures). Transdiaphragmatic pressure is calculated as the difference between esophageal pressure and gastric pressure. | Measurements will be collected at 2-hr intervals after the evening dose of randomized study medication (i.e., 2, 4, 6, 8 and 10 hrs post-dose) |
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