Copd Clinical Trial
— COPDOfficial title:
Assessment of Bronchodilator Efficacy of Formoterol/Budesonide 12/400 mcg Via Discair in Chronic Obstructive Pulmonary Disease (COPD)
NCT number | NCT03028701 |
Other study ID # | NEU-20.13 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | March 2017 |
Verified date | January 2017 |
Source | Neutec Ar-Ge San ve Tic A.S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 33 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Patients aged =40 years with newly or formerly diagnosed moderate to severe COPD (Patients with postbronchodilator FEV1/FVC ratio <0.70, and FEV1 <80% of predicted normal. Patients have chronic cough or chronic productive cough with breathlessness even walking slowly along flat ground.) Current smokers or exsmokers with a smoking history of at least 10 pack-years - Patients who have no exacerbation within last 4 weeks - Females patients with childbearing potential using effective birth control method - Patients who has a capability of communicate with investigator - Patients who accept to comply with the requirements of the protocol - Patients who signed written informed consent prior to participation Exclusion Criteria: - Patients who have history of hypersensitivity to drugs contains long-acting beta2-agonist or corticosteroids - Patients who have abnormal blood glucose level ((=140 mg/dl) - Patients who have unregulated diabetes mellitus - Patients who have a serum potassium level of =3.5 mEq/L or >5.5mEq/L - Patients who have asthma - Patients who have a history of myocardial infarction, severe hearth failure, acute ischemic coroner disease or severe cardiac arrhythmia requiring treatment within least 6 weeks - Patients who have lung cancer - Patients vaccinated with live attenuated vaccines within 2 weeks prior to screening visit or during run-in period. - Patients who had COPD exacerbation or lower respiratory track infections that required antibiotic, oral or parenteral corticosteroid treatment within 4 weeks prior to screening visit or during run-in period. - Women who are pregnant or nursing - History of allergic rhinitis or atopy |
Country | Name | City | State |
---|---|---|---|
Turkey | Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Neutec Ar-Ge San ve Tic A.S |
Turkey,
Yildiz P, Bayraktaroglu M, Gorgun D, Yuksel K. Bronchodilator Efficacy of a Single-Dose 12/400-µg Formoterol/Budesonide Combination as a Dry Powder for Inhalation Delivered by Discair(®) in Adult Patients with Moderate-to-Severe Stable COPD: Open-Label, S — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean max improvement (ml) from baseline in FEV1 over a period of 12 h. | Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr. | Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1) | |
Primary | The time to onset of max improvement from baseline in FEV1. | Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr. | Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1) | |
Secondary | Mean absolute change (ml) from baseline in FEV1 over a period of 12 h (over spirometric measurement period). | Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr. | Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1) | |
Secondary | Mean absolute change (ml) from baseline in FVC over a period of 12 h (over spirometric measurement period). | Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr. | Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1) | |
Secondary | Mean % change from baseline in FEV1 over a period of 12 h (over spirometric measurement period). | Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr. | Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1) | |
Secondary | Mean % change from baseline in FVC over a period of 12 h (over spirometric measurement period). | Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr. | Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1) | |
Secondary | FEV1 (AUC0-12) response | Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr. | Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1) | |
Secondary | FVC (AUC0-12) response | Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr. | Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1) | |
Secondary | Evaluation of safety | (Physical examination, numbers of adverse reactions and abnormal laboratory values related | Predose and up to 12 hours postdose |
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 |