The Effect of Twice Daily vs. Once Daily Bronchodilation on Hyperinflation in COPD Patients During 24 Hours.

NCT03275116 | Unknown Phase 4

• 1 other identifier: 59452
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

To study the effect of twice daily dual bronchodilation versus once daily single bronchodilation in patients with chronic obstructive pulmonary disease on 24-hour static and dynamic hyperinflation.

Conditions

Chronic Obstructive Airway Disease

Keywords

Bronchodilation; Hyperinflation; Physical activity; Sleep quality

Outcome Measures

Primary Outcomes (1)

• Static hyperinflation

  Residual volume (RV) measured by repeated body box measurements

  24 hours

Secondary Outcomes (9)

• Dynamic hyperinflation

  24 hours

• Airway obstruction

  24 hours

• Forced vital capacity

  24 hours

• Inspiratory vital capacity

  24 hours

• Momentarily symptoms of dyspnea

  24 hours

Study Arms (2)

Twice daily dual bronchodilation

ACTIVE COMPARATOR

Twice daily Aclidinium Bromide/Formoterol Fumarate 340/12 mcg during 4 days

Drug: Tiotropium 'Respimat' 5 mcg

Once daily single bronchodilation

ACTIVE COMPARATOR

Once daily Tiotropium 'Respimat' 5 mcg during 4 days

Drug: Aclidinium Bromide/Formoterol Fumarate 340/12 mcg

Interventions

Tiotropium 'Respimat' 5 mcg DRUG

Once daily single bronchodilation

Also known as: Spiriva 'Respimat'

Twice daily dual bronchodilation

Aclidinium Bromide/Formoterol Fumarate 340/12 mcg DRUG

Twice daily dual bronchodilation

Also known as: Duaklir Genuair

Once daily single bronchodilation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults (with an equal sex ratio not exceeding 35-65%) aged ≥ 40 years with written informed consent obtained prior to any study-related procedure.
• Patients entering pulmonary rehabilitation at CIRO.
• Patients with a diagnosis of moderate to very severe COPD at least 12 months before the screening visit (A post-bronchodilator FEV1 \< 80% of the predicted normal value and a post-bronchodilator FEV1/FVC \< 0.7 at least 10-15 min after 4 puffs (4 x 100 μg) of salbutamol)
• Patients with severe static hyperinflation defined as residual volume (body box) \> 150 % predicted.
• Current smokers or ex-smokers with a smoking history of at least 10 pack years \[pack-years = (number of cigarettes per day x number of years)/20\].
• MMRC (modified Medical Research Council Dyspnea scale) score ≥ 2.

You may not qualify if:

• Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential)
• Patients requiring use of the following medications:
• A course of systemic steroids longer than 3 days for COPD exacerbation in the 4 weeks prior to screening.
• A course of antibiotics for COPD exacerbation longer than 7 days in the 4 weeks prior to screening. NB; maintenance treatment of macrolides is allowed, without any changes in the regimen in the 4 weeks prior to the study.
• PDE4 (phosphodiesterase-4) inhibitors in the 4 weeks prior to screening.
• Xanthines in the 4 weeks prior to screening.
• Use of antibiotics for a lower respiratory tract infection (e.g pneumonia) in the 4 weeks prior to screening.
• COPD exacerbation requiring prescriptions of systemic corticosteroids and/or antibiotics or hospitalization during the run-in period.
• Patients treated with non-cardio selective β-blockers in the month preceding the screening visit or during the run-in period. Those patients may enter the study after non-selective β-blockers withdrawal and/or cardio selective β-blockers intake for at least 10 days before the first study day.
• Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study, or if taken as PRN (Pro Re Nata).
• Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
• Known respiratory disorders other than COPD which may impact the efficacy of the study drug according the investigator's judgment. This can include but is not limited to alpha-1 antitrypsin deficiency, active tuberculosis, a history of asthma, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease.
• Previous lung surgery or endoscopic lung volume reduction interventions.
• Patients who have clinically significant cardiovascular condition such as, but not limited to, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, acute ischemic heart disease in the last year prior to study screening, history of sustained cardiac arrhythmias or sustained and non-sustained cardiac arrhythmias diagnosed in the last 6 months (sustained means lasting more than 30 seconds and or ending only with external action, and or leads to hemodynamic collapse; non-sustained means \> 3 beats \< 30 seconds, and or ending spontaneously, and or asymptomatic), impulse conduction high degree blocks, patients with Implantable Cardioverter Defribrillator (ICD).
• Patients with atrial fibrillation (AF):

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Center for Integrated Rehabilitation and Organ Failure Horn: collaborator
• AstraZeneca: collaborator

Study Sites (1)

Ciro, center of expertise in chronic organ failure

Horn, 6085NM, Netherlands

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity; Sleep Initiation and Maintenance Disorders

Interventions

aclidinium bromide; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Lowie Vanfleteren, MD, PhD

  CIRO, centre of expertise for chronic organ failure

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lowie Vanfleteren, MD, PhD

CONTACT

+31475587644; lowievanfleteren@ciro-horn.nl

Maud Koopman, MD

CONTACT

+31475587653; maudkoopman@ciro-horn.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: September 7, 2017
• Study Start: July 7, 2017
• Primary Completion: April 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

NL (1)