Non-interventional Study of Spirometry Use to Diagnose COPD (Chronic Obstructive Pulmonary Disease) and to Prescribe Treatment to COPD Patients in the Outpatient Institutions

NCT02248909 | Completed

• 1 other identifier: NIS-RRU-XXX-2014/2
• Study Type: observational
• Target: 4,232
• Locations: 1 country
• Sites: 22

Brief Summary

This study is an observational multicenter descriptive study. The study will be conducted in primary outpatient medical institutions in different cities of the RF. Primary care doctors who are primary contact for greater part of the population in RF including COPD patients will be invited as investigators. This observational descriptive study will be conducted within the routine practice of outpatient institutions. Since spirometry is not an integral part of the current all-round clinical practice, only those sites where spirometry test is routinely used in examination of patients with COPD risk factors and when monitoring condition of COPD patients will take part in the study. Thus the decision about spirometry in every study subject will be determined only by the existing treatment approaches.

Conditions

COPD

Keywords

COPD, Primary Care, Spirometry, Risk factors

Outcome Measures

Primary Outcomes (3)

• The number of COPD cases first-time identified by the spirometry in relation to the total number of patients who visited the outpatient institutions of the RF during the study

  Up to 5 months

• Percentage of prescriptions for patients with COPD that correspond to the severity of the condition of the patients according to GOLD classification and GOLD recommendations for the treatment choice

  Up to 5 months

• Distribution (%) of patients with COPD who contacted the primary care doctors during the study based on bronchial obstruction severity (GOLD 1-4) and classes according to GOLD classification (2014)

  Up to 5 months

Secondary Outcomes (6)

• The percentage (%) of patients who contact the medical institutions of RF daily can be referred to the group with risk of COPD development

  Up to 5 months

• Score on SGRQ at 1st Visit in COPD patients receiving monotherapy with inhaled long-acting and super long-acting bronchodilators and in patients who are treated with combined drugs containing inhaled corticosteroids and long-acting β2 agonists

  Up to 5 months

• Score on САТ at 1st Visit in COPD patients receiving monotherapy with inhaled long-acting and super long-acting bronchodilators and in patients who are treated with combined drugs containing inhaled corticosteroids and long-acting β2 agonists

  Up to 5 months

• Mean number of puffs of SABA for 24h in COPD patients receiving monotherapy with inhaled long-acting and super long-acting bronchodilators and in patients treated with combined drugs (inhaled corticosteroids and long-acting β2 agonists)

  Upto 5 months

• The percentage of COPD patients in the routine practice of these medical institutions

  Up to 5 months

Study Arms (2)

Patients with COPD risk factors

Group of subjects with COPD risk factors. This group will include patients aged ≥40 years, with smoking history of ≥10 pack years and long-active (not less than 3 consequent months) respiratory complaints

Patients previously diagnosed with COPD

Group of patients who according to the medical records have already been diagnosed with COPD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with COPD risk factors and patients with previously diagnosed COPD who have been observed in outpatient medical institutions of the RF are planned to be enrolled into the study.

You may qualify if:

• Age ≥ 40 years.
• Smoker or former smoker with smoking history of ≥ 10 pack years (patient is considered to be a former smoker in case of smoking cessation for ≥6 months) (the patient smokes or smoked before but then gave up smoking. The obligatory condition: smoking history is ≥10 pack years. It means that the patient smoked a pack per day for 10 years or half a pack for 20 years or 2 packs a day for 5 years).
• Any complaints judged by the investigator to be possibly related to the respiratory diseases (chronic cough, dyspnea, cough with sputum, feeling of stiffness in the chest) or the evidence of the chronic respiratory diseases (chronic bronchitis in remission, pneumosclerosis) in the medical chart.
• The patient is expected to have the spirometry test performed in accordance with the current medical practice before inviting him to the study.
• Patients considered by the investigator to be able to complete themselves questionnaires used in the current study.
• Signed Patient's Information Sheet and Informed Consent Form.
• Male and female of any age who were diagnosed with COPD before the study starts.
• Patients whose COPD was not the direct reason for visiting the doctor or COPD patients who have COPD symptoms or signs requiring diagnostic or therapy.
• Patients judged by the investigator as being capable to complete themselves the questionnaires used in the current study
• Patient was scheduled to have the spirometry test performed in accordance with the existing medical practice before inviting him/her into the study
• Signed Patient's Information Sheet and Informed Consent Form.

You may not qualify if:

• Previously diagnosed chronic obstructive pulmonary disease.
• Patients diagnosed with asthma, pulmonary tuberculosis, congenital lung abnormality, cystic fibrosis, lung cancer or cancer of the upper respiratory tract, patients who had a lung resection in the past due to pulmonary tuberculosis and other lung surgery, patients with stenosis of the upper respiratory tract, post-tracheotomy patients with the developed fibrotic stenosis of the trachea or post-intubation trachea stenosis, patients with ribs fractures of \<3 weeks, pneumo- and hydrothorax of any etiology.
• Patients who have contraindications for performing spirometry tests, patients with acute coronary syndrome or unstable circulatory dynamics. Patients who need emergency medical care at the moment of the visit.
• Participation in any interventional clinical trial within 3 months prior the enrollment into the study and at the moment.
• Patients diagnosed with asthma, pulmonary tuberculosis, congenital lung abnormality, cystic fibrosis, lung cancer or cancer of the upper respiratory tract, patients who had a lung resection in the past due to pulmonary tuberculosis and other lung surgery, patients with stenosis of the upper respiratory tract, post-tracheotomy patients with fibrotic stenosis of the trachea or post-intubation trachea stenosis, patients with rib fractures of \<3 weeks, pneumo- and hydrothorax of any etiology.
• Active exacerbation of chronic obstructive pulmonary disease at the moment of enrollment into the study.
• Patients who have contraindications for performing spirometry tests, patients with acute coronary syndrome or unstable hemodynamics. Patients who need emergency medical care at the time of the visit.
• Participation in any interventional clinical trial within 3 months prior the enrollment into the study and at the moment.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (22)

Research Site

Barnaul, Nis-rru-xxx-2014/2, Russia

Location

Research Site

Blagoveshchensk, Nis-rru-xxx-2014/2, Russia

Location

Research Site

Chelyabinsk, Nis-rru-xxx-2014/2, Russia

Location

Research Site

Cherepovets, Nis-rru-xxx-2014/2, Russia

Location

Research Site

Izhevsk, Nis-rru-xxx-2014/2, Russia

Location

Research Site

Kazan', Nis-rru-xxx-2014/2, Russia

Location

Research Site

Kemerovo, Nis-rru-xxx-2014/2, Russia

Location

Research Site

Krasnoyarsk, Nis-rru-xxx-2014/2, Russia

Location

Research Site

Moscow, Nis-rru-xxx-2014/2, Russia

Location

Research Site

Naberezhnye Chelny, Nis-rru-xxx-2014/2, Russia

Location

Research Site

Novosibirsk, Nis-rru-xxx-2014/2, Russia

Location

Research Site

Omsk, Nis-rru-xxx-2014/2, Russia

Location

Research Site

Petrozavodsk, Nis-rru-xxx-2014/2, Russia

Location

Research Site

Ryazan, Nis-rru-xxx-2014/2, Russia

Location

Research Site

Saint Petersburg, Nis-rru-xxx-2014/2, Russia

Location

Research Site

Smolensk, Nis-rru-xxx-2014/2, Russia

Location

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Tomsk, Nis-rru-xxx-2014/2, Russia

Location

Research Site

Ulan-Ude, Nis-rru-xxx-2014/2, Russia

Location

Research Site

Vladivostok, Nis-rru-xxx-2014/2, Russia

Location

Research Site

Yakutsk, Nis-rru-xxx-2014/2, Russia

Location

Research Site

Yfa, Nis-rru-xxx-2014/2, Russia

Location

Research Site

Stavropol, Nis-rru-xxx-2014/3, Russia

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Bedenkov

  AstraZeneca

  STUDY DIRECTOR

• Vladimir Archipov, Prof.

  I.M. Sechenov First Moscow State Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: September 25, 2014
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 1, 2016

Record last verified: 2016-01

Locations

RU (22)