Determination of the local inflammatory response in patients with COPD by wood smoke and COPD per cigarette

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

HUMO

Scientific title:

Acronym of Scientific Title:

HUMO

Secondary indentifying numbers:

001

002

Issuing authority of the secondary identifying numbers:

Fundacion Neumologica Colombiana

Universidad de la Sabana Bogota

Source(s) of monetary or material support:

Fundacion Neumologica Colombiana Universidad de la Sabana Bogota

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Angela

Midle name:

Maria

Last name:

Giraldo Montoya

Medical Specialty :

Internal Medicine, Neumology

Affiliation:

Fundacion Neumologica Colombiana

Postal address:

Cra. 13b #161-85

City:

Bogota

Country:

Colombia

Zip Code:

110131

Telephone:

+57-7428888 ext. 571

+57-7428903 ext. 571

Email address:

angelagiral@gmail.com

agiraldo@neumologica.org

investigacion@neumologica.org

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Colombia

Clinical sites:

Not applicable

Research ethics committees:

Research Ethics Committee of Fundacion Neumologica Colombiana, June 20th, 2015 (Approval 210)

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

11/11/2015

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Chronic Obstructive Pulmonary Disease (COPD)

Health condition(s) code:

Pulmonary Disease, Chronic Obstructive

Lung Diseases, Obstructive, Lung Diseases, Respiratory Tract Diseases

Intervention(s):

Group 0: healthy patients. Each participant will carry out pre and post bronchodilator spirometry for COPD diagnosis by spirometric criteria. Sputum induction will make each participant, after making hypertonic saline 5% nebulization. Group 1: COPD Cigarette smoke. Each participant will carry out pre and post bronchodilator spirometry for COPD diagnosis by spirometric criteria. Sputum induction will make each participant, after making hypertonic saline 5% nebulization. Group 2: wood smoke COPD. Each participant will carry out pre and post bronchodilator spirometry for COPD diagnosis by spirometric criteria. Sputum induction will make each participant, after making hypertonic saline 5% nebulization.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Smoker (over 10 packets/year: dichotomic). Measuring time: at baseline Cooking with wood (more than 10 years of exposure in enclosed: dichotomic). Measuring time: at baseline Hospitalizations for COPD (no earlier than 8 weeks: dichotomi c). Measuring time: at baseline Using long-acting anti cholinergic (dichotomic). Measuring time: at baseline Use of short-acting anti cholinergic (dichotomic). Measuring time: at baseline Use of systemic steroids (dichotomic). Measuring time: at baseline Use of local steroids (dichotomic). Measuring time: at baseline Statin use (dichotomic). Measuring time: at baseline Spirometric parameter FEV1 / FVC ratio less than 0.70 (interval). Measuring time: at baseline Bronchodilator spirometry FEV1% predicted parameter (interval). Measuring time: at baseline Levels of IL-8 pg/ml (quantitative). Measuring time: after completing the sputum sampling in all subjects VEGF levels pg/ml (quantitative). Measuring time: after completing the sputum sampling in all subjects MMP-9 ng/ml (quantitative). Measuring time: after completing the sputum sampling in all subjects CC16 levels pg/ml (quantitative). Measuring time: after completing the sputum sampling in all subjects Levels of CCL-5 pg/ml (quantitative). Measuring time: after completing the sputum sampling in all subjects

Key secondary outcomes:

Age (quantitative: completed years). Measuring time: at baseline Hometown (qualitative: rural urban). Measuring time: at baseline Marital status (qualitative: single-married-union freely widower separately). Measuring time: at baseline Coexists (nominal: with single-family). Measuring time: at baseline Schooling (ordinal: primary-university-technological-no). Measuring time: at baseline Social security (nominal qualitative: subsidized-contributory-other). Measuring time: at baseline

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Female

Minimum age:

40 years

Maximum age:

90 years

Inclusion criteria:

1. Patients with COPD defined by spirometric criteria diagnostic of GOLD 2. Exposure to smoke by cigarrette with package / year indice greater than 10 P / A 3. Exposure to wood smoke for over 10 years 4. Age older than 40 and younger than 90 years 5. Acceptance of the informed consent

Exclusion criteria:

1. Medical history of lung diseases such as history of asthma, cystic fibrosis, tuberculosis, bronchiectasis 2. Presence of lower respiratory tract infection in the four weeks prior to sampling. 3. History of exacerbation of the disease in the four weeks prior to sampling. 4. Patients with severe COPD according to GOLD classification 5. Immunosuppression by comorbidities (autoimmune disease, cancer, chronic use of corticosteroids, HIV infection). 6. Simultaneous exposure to wood smoke and smoking. 7. Inability to perform spirometry 8. Inability sampling induced sputum 9. No acceptance of the informed consent

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Observational

Purpose:

Other

Other purpose:

determine differences in molecular markers in sputum of patients with COPD by different etiologies

Allocation:

N/A: single arm study

Masking:

Open

Control group:

No intervention

Study design:

Other

Other design:

observational study (transversal)

Phase:

N/A

Target sample size:

90

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Angela

Middle Name:

Maria

Last Name:

Giraldo Montoya

Specialty:

Internal Medicine and Neumology

Affiliation:

Fundacion Neumologica Colombiana

Postal Address:

Cra. 13b #161-85

City:

Bogota, Cundinamarca

Country:

Colombia

Zip Code:

110131

Telephone:

+57315-4016007

Email :

angelagiral@gmail.com

agiraldo@neumologica.org

investigacion@neumologica.org

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Angela

Middle Name:

Maria

Last Name:

Giraldo Montoya

Specialty:

Internal Medicine and Neumology

Affiliation:

Fundacion Neumologica Colombiana

Postal Address:

Cra. 13b # 161-85

City:

Bogota, Cundinamarca

Country:

Colombia

Zip Code:

110131

Telephone:

+57315 4016007

Email :

angelagiral@gmail.com

agiraldo@neumologica.org

investigacion@neumologica.org

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000210

Date of Registration in Primary Registry:

01/02/2016

Record Verification Date:

2016/02/01

Next update date:

2017/02/01

Link to the spanish version:

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Registered Trials

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Determination of the local inflammatory response in patients with COPD by wood smoke and COPD per cigarette

About the RPCEC

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