Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Influence of Electronic Cigarettes in the Evaluation of the Inflammatory Response in Patients With a Diagnosis of COPD
This study evaluates the local and systemic inflammatory response in the airway in COPD patients who consume electronic cigarettes compared with conventional cigarette smokers.
Chronic obstructive pulmonary disease (COPD) is an illness with high morbidity and mortality
in our society with a prevalence of about 10% of the population. Smoking represents the main
risk factor for development of COPD having been associated with a greater decrease in lung
capacity and increased mortality. Therefore, early treatment of smoking habit is an essential
therapeutic approach.
The first line drug treatments have proven effective for smoking cessation, on the other hand
the introduction of electronic cigarettes has brought a wide impact on our society,being
considered as possible replacements in patients with difficulties in quitting the habit;
however there is still limited information on its use in addition to some undesirable effects
that have been described such as the lipoid pneumonia.
Recent clinical trials have shown that the use of electronic cigarettes may be associated
with symptoms like dry cough, mouth irritation, dyspnea, and headache. On the other hand it
has also been associated with increased airway resistance, an immediate decrease of exhaled
nitric oxide (FeNO) and FEV1.
Our study aim to assess the inflammatory response in COPD patients who are regular consumers
of electronic cigarettes compared with conventional cigarette smokers. The inclusion criteria
in the study are: male patients diagnosed with COPD Gold B and C according to international
guidelines that are regular smokers with no desire to quit their smoking habit. Exclusion
criteria includes those with serious cardiovascular disease, chronic inflammatory disease,
active oncologic disease of any origin, use of corticosteroids or other drugs with
anti-inflammatory effect and finally COPD patients with acute exacerbation in the last twelve
weeks.
Patients will be randomized into two groups: users of conventional and electronic cigarette.
All patients in the second group will be provided with the same type of electronic cigarette
and doses of inhaled nicotine.
We will perform a complete clinical characterization of the patients collecting data related
with their smoking habit, daily consumption, tests to assess the degree of dependence and
withdrawal symptoms, level of dyspnea and symptoms associated with tobacco consumption.
We will perform a complete respiratory functional test including spirometry, diffusion
capacity and measurement of exhaled carbon monoxide levels. Inflammatory involvement of the
airway will be examined by assessing the concentration of exhaled nitric oxide, studying the
percentage of neutrophils and eosinophils in induced sputum and a general analysis for
determination of inflammatory mediators: IL1B, IL6, IL8, factor alpha and C-reactive protein
tumor necrosis.
The results will be evaluated by statistical tests. The results obtained will provide us with
information about the effect of the electronic cigarette in COPD and its effectiveness in
smoking cessation.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05102305 -
A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
|
||
Completed |
NCT01867762 -
An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Recruiting |
NCT05562037 -
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
|
N/A | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03089515 -
Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
|
N/A | |
Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
Recruiting |
NCT05552833 -
Pulmonary Adaptive Responses to HIIT in COPD
|
N/A | |
Recruiting |
NCT05835492 -
A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
|
||
Recruiting |
NCT05631132 -
May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?
|
N/A | |
Completed |
NCT03244137 -
Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
|
||
Not yet recruiting |
NCT03282526 -
Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease
|
N/A | |
Completed |
NCT02546700 -
A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 2 | |
Withdrawn |
NCT04446637 -
Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD
|
Phase 3 | |
Completed |
NCT04535986 -
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
|
Phase 3 | |
Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
Completed |
NCT03256695 -
Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT03295474 -
Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
|
||
Withdrawn |
NCT04042168 -
Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
Completed |
NCT03414541 -
Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Completed |
NCT02552160 -
DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy
|