Copd Clinical Trial
Official title:
Assessment of Bronchodilator Efficacy of Formoterol/Budesonide 12/400 mcg Via Discair in Chronic Obstructive Pulmonary Disease (COPD)
The overall objective is to asses the bronchodilator effect of single dose of
Formoterol/Budesonide 12/400 mcg fixed combination delivered via Discair® in patients with
COPD.
Spirometric measurements (FEV1, FVC) will be performed for a period of 12 h at 12 different
times: pretreatment (prior to the first dose) and posttreatment (15. min, 30. min, 1 hr, 2
hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr ve 12 hr).
The overall objective is to asses the bronchodilator effect of single dose of
Formoterol/Budesonide 12/400 mcg fixed dose combination delivered via Discair® in patients
with COPD.
Patients will be assigned to receive single dose of Formoterol/Budesonide 12/400 mcg fixed
dose combination delivered via Discair® (test product, n = 33). Patients will be evaluated at
4 consecutive visits: baseline (enrollment), screening, treatment, and end of treatment (24h
after treatment).
For newly diagnosed and formerly diagnosed patients who are not on COPD medication, the
screening visit will be performed on the day of enrollment. For formerly diagnosed patients
receiving COPD treatment, the day of the screening visit will be based on the completion of a
run-in period, with the length determined by the specific medication. During the run-in
period, salbutamol (100 μg inhaler) will be prescribed as a rescue medication.
Spirometric measurements (FEV1, FVC) will be performed for a period of 12 h at 12 different
times: pretreatment (prior to the first dose) and posttreatment (15. min, 30. min, 1 hr, 2
hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr ve 12 hr).
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT06000696 -
Healthy at Home Pilot
|
||
Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
||
Completed |
NCT04043728 -
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
|
N/A | |
Completed |
NCT04105075 -
COPD in Obese Patients
|
||
Recruiting |
NCT05825261 -
Exploring Novel Biomarkers for Emphysema Detection
|
||
Active, not recruiting |
NCT04075331 -
Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial
|
Phase 2/Phase 3 | |
Terminated |
NCT03640260 -
Respiratory Regulation With Biofeedback in COPD
|
N/A | |
Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|
||
Withdrawn |
NCT04210050 -
Sleep Ventilation for Patients With Advanced Hypercapnic COPD
|
N/A | |
Terminated |
NCT03284203 -
Feasibility of At-Home Handheld Spirometry
|
N/A | |
Recruiting |
NCT06110403 -
Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT06040424 -
Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
|
Phase 3 | |
Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
Recruiting |
NCT04868357 -
Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program
|
N/A | |
Completed |
NCT01892566 -
Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV
|
N/A | |
Completed |
NCT04119856 -
Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD
|
N/A | |
Completed |
NCT04485741 -
Strados System at Center of Excellence
|
||
Completed |
NCT03626519 -
Effects of Menthol on Dyspnoea in COPD Patients
|
N/A | |
Recruiting |
NCT04860375 -
Multidisciplinary Management of Severe COPD
|
N/A |