Asthma Respiratory Asthma
Conditions
Interventions
25 patients with asthma were randomly selected from a group of asthma patients at the hospital who met the inclusion criteria using a random number generator. Each participant had a matched healthy co
Sponsors
Pulmonary Clinic and Respiratory Failure Unit of Aristotle University of Thessaloniki, General Hospital of Thessaloniki ''Georgios Papanikolaou''
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Asthma patients: 1. Every-day smoker: 1.1. Smoked at least 100 cigarettes in their lifetime 1.2. Smoke every day at the time of research 2. Moderate asthma 3. Aged over 18 years old Healthy controls: 1. Every-day smoker: 1.1. Smoked at least 100 cigarettes in their lifetime 1.2. Smoke every day at the time of research 2. Visited the smoking cessation clinic or other pulmonary dispensaries of the hospital during the research 3. Aged over 18 years old Healthy controls were matched with asthma patients on baseline characteristics including age, gender, height, weight, BMI and number of pack-years.
Exclusion criteria
Exclusion criteria: For the group of asthma patients: 1. Mild or severe asthma and not receiving therapy of "step 3" according to 2016 GINA guidelines 2. Any chronic disease other than asthma 3. Acute asthma exacerbation the last month before the study 4. Use of corticosteroids 5. Any acute disease 2 weeks prior to the study. 6. Use of any medication except for asthma treatment currently or in the 2 weeks prior to study participation 7. Having smoked since their morning awakening and/or had an Exhaled CO measurement of over 5 ppm the day they would take part in the study For the control group: 1. Any chronic disease 2. Any acute disease currently or in the 2 weeks prior to study participation 3. Having smoked since their morning awakening and/or had an Exhaled CO measurement of over 5 ppm the day they would take part in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the Fraction of Exhaled Nitric Oxide (FENO) before and after the use of the e-cigarette in patients with asthma, compared to changes at the same timepoints in healthy controls. Participants underwent FENO measurements, and then were asked to smoke an e-cigarette for 5 minutes. After 30 minutes, participants underwent another FENO measurement. FENO measurements were performed using the Denox 88 ECOMEDICS. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pulmonary function, assessed at the baseline and 15 minutes after participants smoked the e-cigarette to measure the following: 1.1. Pulmonary function tests (PFTs) using the MasterScreen PFT JAEGER, including: 1.1.1. Vital capacity (VC) 1.1.2. Inspiratory capacity (IC) 1.1.3. Maximum voluntary ventilation (MVV) 1.1.4. Forced vital capacity (FVC) 1.1.5. Forced experiatory volume in 1 second (FEV1) 1.1.6. FEV1 to FVC ratio 1.1.7. Mean mid-expiratory flow (MMEF) 1.1.8. Peak expiratory flow rate (PEFR) 1.1.9. Forced expiratory flow at 25%, 50% and 75% of FVC manoeuvre 1.1.10. Peak inspiratory flow (PIF) 1.1.11. Tidal volume and breathing frequency during MVV manuoeuvre 1.1.12. Vital capacity IN during diffusion manuoevre (VIN) 1.1.13. Functional residual capacity (FRC) 1.1.14. Residual volume (RV) 1.1.15. Expiratory reserve volume (ERV) 1.1.16. Total lung capacity (TLC) 1.1.17. RV to TLC ratio 1.1.18. FLC to TLC ratio 1.1.19. Alveolar volume (VA) 1.1.20. Transfer factor for carbon monoxide with the single-breath method (TLCOSB) 1.1.21. TLCO to VA ratio 1.2. Impulse oscillometry (IOS) using the Viasys Jaeger Masterscreen IOS system, including: 1.2.1. Tidal volume (VT) 1.2.2. Impedance at 5 Hz (Z5) 1.2.3. Resistance at 5, 10, 15, 20, 25 and 35 Hz (R5, R10, R15, R20, R25 and R35) 1.2.4. Reactance at 5, 10, 15, 20, 25 and 35 Hz (X5, X10, X15, X20, X25 and X35) 1.2.5. Resonant frequency (Fres) 1.2.6. Central and peripheral resistances (Rcentral and Rperipheral) 2. Airway inflammation, assessed using exhaled breath condensate (EBC) gathering at the baseline and 30 minutes after participants smoked the e-cigarette, using the EcoScreen for EBC at -10 °C, to measure the following: 2.1. pH, measured using an Orion Ross microelectrode and an Orion Star pHmeter 2.2. Concentrations of interleukins (IL) 1ß, 4, 5, 6, 8, 10, 13 and 17A, measured using flow cytometry 2.3. Tumour necrosis factor alpha (TNFa), measured using flow cytometry 2.4. 8-isoprostane (ISO8), measured using ELI | — |
Countries
Greece
Outcome results
None listed