Non-interventional Study of spirometry Use to diagnose COPD (Chronic Obstructive Pulmonary Disease) and to Prescribe treatment to COPD patients in the outpatient institutions - SUPPORT

Study identifier:NIS-RRU-XXX-2014/2

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Non-interventional multicenter Study of spirometry Use to diagnose COPD and to Prescribe treatment to COPD patients in the outpatient institutions of the healthcaRe system of the Russian FederaTion

Medical condition

COPD

Phase

N/A

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

4232

Study type

Observational

Age

N/A

Date

Study Start Date: 01 Nov 2014

Primary Completion Date: 01 May 2015

Study Completion Date: 01 May 2015

Study design

Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Jan 2016 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

:
1. Age ≥ 40 years.
2. 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).
3. 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.
4. The patient is expected to have the spirometry test performed in accordance with the current medical practice before inviting him to the study.
5. Patients considered by the investigator to be able to complete themselves questionnaires used in the current study.
6. Signed Patient’s Information Sheet and Informed Consent Form.
Patients with previously diagnosed COPD must meet all the following inclusion criteria:
1. Male and female of any age who were diagnosed with COPD before the study starts.
2. 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.
3. Patients judged by the investigator as being capable to complete themselves the questionnaires used in the current study
4. Patient was scheduled to have the spirometry test performed in accordance with the existing medical practice before inviting him/her into the study
5. Signed Patient’s Information Sheet and Informed Consent Form.

Exclusion Criteria

for patients with COPD risk factors:
1. Previously diagnosed chronic obstructive pulmonary disease.
2. 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.
3. 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.
4. Participation in any interventional clinical trial within 3 months prior the enrollment into the study and at the moment.
Patients with previously diagnosed COPD must meet all the following inclusion criteria:
1.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.
2. Active exacerbation of chronic obstructive pulmonary disease at the moment of enrollment into the study.
3. 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.
4. Participation in any interventional clinical trial within 3 months prior the enrollment into the study and at the moment.

No locations available

Arms	Assigned Interventions
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	-

Documents available

CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

Andrey Ipatov

+74957995699