Effects of treatment and withdrawal with inhaled beclomethasone/formoterol on lung inflammation in COPD.

• Conditions: Chronic obstructive pulmonary disease (COPD); MedDRA version: 14.1Level: LLTClassification code 10029977Term: Obstructive chronic bronchitisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-001749-42-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-28
• Last Update Posted: 28 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Patient is male or female, at least 40 years of age and no more than 85 years.
- Patient has mild, moderate or severe COPD (stage I-III) according to the GOLD guidelines with a FEV1/FVC < 70% and FEV1 > 30% of the predicted value. Diagnosis of COPD will be based on GOLD guideline criteria (16).
- Reversibility to short-acting beta-agonists (SABA) (400 ?g equivalent of salbutamol) of less than 200 ml or less than 12% predicted value FEV1.
- Patients will be on a constant dose of ICS/LABA (ICS: 1000 ?g/day of fluticasone or equivalent) for at least 8 weeks before study enrolment.
- No acute exacerbations in the previous 3 months.
- No history of systemic disease or other pulmonary disease.
- No treatment with systemic glucocorticoids in the previous 4 weeks.
- No history of asthma or atopic disease.
- Current treatment for COPD can include SABA alone as needed or long-acting antimuscarinic drugs on regular basis.
- Apart from COPD, subjects are in good psycho-physical conditions based on history, physical examimantion and laboratory tests, and are able to complete the study.
-Ability to perform reproducible spirometry.
-Patient is a nonsmoker and has stopped smoking for at least one year.
-Ability of patient to provide informed consent, as evidenced by signing a copy of the consent form approved by the institutional review board of the subject’s respective study institution.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion Criteria

1.Patient is, in the opinion of the investigator, mentally or legally incapacitated preventing informed consent from being obtained, or cannot read or comprehend written material.
2.Patient is hospitalized.
3.Patient has undergone any major surgical procedure in the previous four weeks.
4.Patient has participated in a clinical trial involving an investigational or marketed drug in the previous four weeks.
5.Subjects who were current smokers in the previous year.

Pulmonary
5.Patient has, in addition to COPD, any active, acute or chronic pulmonary disorder documented by history or physical examination.
6.Patient has history of asthma and/or reversibility to short-acting beta-agonists (SABA) (400 ?g equivalent of salbutamol) ? 200 ml or ? 12% predicted value FEV1.
7.Patient has ever been intubated for COPD, has required acute COPD therapy treated in an emergency room/urgent care facility/office setting within one month or has been hospitalized for COPD in the previous three months or required 2 or more hospitalizations for COPD in the past year.
8.Patient had an upper respiratory tract infection (URI) in the previous three weeks.

General Medical
4.Patient is hypersensitive to inhaled ?-agonists or their components.
5.Patient has a clinically significant, active disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary, or haematological systems, or has uncontrolled hypertension (>160/95), or an immunodeficiency, or an autoimmune disorder.
6.Patient has a history of any illness that could be immediately life threatening (ventricular arrhythmia, neoplasia, incompletely cured or treated in the last three months, 'brittle' diabetes mellitus), or would pose restriction on participation in the study.
Medications
2.Patient has taken the following medications:
5)Oral, intravenous, intramuscular, intra-articular corticosteroids in the previous 4 weeks with the exception of nasal or inhaled corticosteroids administered on a continuous basis.
6)Antibiotics for ?7 consecutive days in the previous 4 weeks.
7)IV gammaglobulin or immunosuppressants in the previous 4 weeks.
8)Beta-receptor-blocking agents (including ocular preparations) in individuals known to be sensitive to these compounds in the previous two weeks.

Procedural
3.Patient is unable to perform acceptable, reproducible spirometry, and peak flow measurements.
4.Patient is unable or unwilling to comply with the study procedures.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified