Smoking Cessation on the Human Airway: Mucus Secretion, Inflammatory and Proteomic Profile in Nose and miRNAs in Blood
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|ClinicalTrials.gov Identifier: NCT02136550|
Recruitment Status : Active, not recruiting
First Posted : May 13, 2014
Last Update Posted : April 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Smoking Smoking Cessation||Behavioral: Smoking cessation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Subjects that entered in the Smoking Cessation Program at Institute Dante Pazzanese of Cardiology State of Sao Paulo|
|Masking:||None (Open Label)|
|Masking Description:||Fluid analysis and other physical measurements|
|Official Title:||Smoking Cessation on the Human Airway: Mucus Secretion, Inflammatory and Proteomic Profile in Nasal Lavage and miRNAs in Blood|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||November 2018|
Experimental: Smoking cessation
36 smokers will participate in the study and will be evaluated at baseline, 6 months e 12 months of the smoking cessation program. If they quit the program, they will be asked to continue the study.
Behavioral: Smoking cessation
Smoking cessation is a program that gives all the support to the subject: orientation, medications, exams, etc
- miRNAs expression [ Time Frame: PParticipants will be followed for the duration of the cessation program, an expected average of 6 months ]Blood sample will be collected in paxgene tube (BD do Brasil, SP, Brasil). MicroRNAs will be extracted from the blood samples by using PAXgene blood miRNA kit (Qiagen Inc., Valencia, USA). PCR Array will be customized (Custom miScript miRNA PCR Array, Qiagen Inc., Valencia, USA) for the miRNAs analysis. The fluorescence signal will be detected by RotorGene (Qiagen Inc., Valencia, USA).
- saccharin transit time test [ Time Frame: Participants will be followed for the duration of the cessation program, an expected average of 6 months ]We evaluate the nasal MCC by measuring nasal saccharine transport time (STT). The subject is asked to avoid alcohol, tea and coffee for 6 hours and to eat or drink nothing for 2 hours before the measurements. The STT assessment is performed in a quiet room at a temperature of 21-22ºC and relative humidity of 63-71%. Subjects sat in a chair and are asked to maintain regular breathing, to avoid deep breathing, coughing, sneezing, sniffing or talking during STT measurements. Twenty-five µg saccharin particles are deposited 2 cm from the anterior end of the non-obstructed nostril and the timer is stopped at the first perception of sweet taste. The maximum delay between the deposition and perception is set at 60 minutes for non-detection.
- Airway acidification by exhaled breath condensate pH [ Time Frame: Participants will be followed for the duration of the cessation program, an expected average of 6 months ]The EBC is obtained as previously described. At the start of EBC collection, all subjects rinse their mouths with distilled water and are instructed to swallow saliva as necessary and to hold a slight head extension (approximately 15o). The EBC sample is collected over 15 min of quiet and normal breathings (regular tidal volumes and respiratory rate) through a mouthpiece that is connected to a collector device with dry ice (-20 °C). The total EBC (2.0-2.5 ml) is immediately divided and transferred to sterile 500 μl polypropylene tubes. One aliquot is immediately used for pH measurements. The remaining EBC sample aliquots are coded (for blinding purposes) and stored for a maximum of 4 weeks at -80°C for the determination of cytokine levels.
- Quality of life by St George Questionnaire [ Time Frame: Participants will be followed for the duration of the cessation program, an expected average of 6 months ]This is a questionnaire validate for Brazilian population to assess the quality of life of individuals with chronic respiratory problems (de Souza et al, 2000)
- inflammation in the upper airway by analysis of nasal lavage [ Time Frame: Participants will be followed for the duration of the cessation program, an expected average of 6 months ]Celularity and determination of TNF-α, IL-1beta, IL1-RA, IL-4, IL-5, IL-6, IL-8, IL-9, IL-10, IL-13, IL-17, MPO, G-CSF, MUC5AC and cotinine (multiplex bead assay and ELISA) in nasal lavage. Celularity: the cell pellet is resuspended in one milliliter of phosphate buffer saline solution (PBS). Thereafter, 20 µl of the mixed solution is added to a Neubauer chamber, and the cells are counted using a 400x light microscope (Olympus CH2, Olympus America Inc., Palo Alto, USA). For differential cell counts, 100 µl of the mixed solution is centrifuged (96 g, 25°C, 6 min) to obtain a slide with two areas of cells that are stained with hematoxylin and eosin. Differential cell counts are performed with the aid of a 1000x light microscope (Olympus CH2, Olympus America Inc., Palo Alto, USA) by two different observers.
- Upper airways symptoms by SNOT20 questionnaire [ Time Frame: Participants will be followed for the duration of the cessation program, an expected average of 6 months ]This is a questionnaire that aims to assess quality of life of patients with chronic upper airways symptoms
- sleep quality by Pittsburg questionnaire [ Time Frame: Participants will be followed for the duration of the cessation program, an expected average of 6 months ]It is a questionnaire to assess the quality of sleep (basically 6 questions)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02136550
|Faculdade de Medicina da Universidade de Sao Paulo|
|Sao Paulo, Brazil, 01246-903|
|Study Director:||Paulo HN Saldiva, Professor||University of Sao Paulo Medical School|
|Principal Investigator:||Naomi K. Nakagawa, Professor||University of Sao Paulo Medical School|