Role and pharmacological modulation of lug inflammation in chronic obstructive pulmonary disease (COPD) - ND

• Conditions: chronic obstructive pulmonary disease; MedDRA version: 12.1Level: LLTClassification code 10008842Term: Chronic bronchitis & emphysema

• Registration Number: EUCTR2009-017872-26-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-29
• Last Update Posted: 12 June 2012

Recruitment & Eligibility

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

Inclusion Criteria

1. Patient is male or female, at least 40 years of age and no more than 85 years. 2. Patient has mild, moderate or severe COPD according to the GOLD guidelines with a FEV1/FVC < 70% and FEV1 > 30% of the predicted value. 3. Reversibility to short-acting beta-agonists (SABA) of less than 200 ml or less than 12% predicted value FEV1 4. No acute exacerbations in the previous 3 months 5. No history of systemic disease or other pulmonary disease 6. No treatment with inhaled or systemic glucocorticoids in the previous 3 weeks. 7. No history of asthma or atopic disease 8. Current treatment for COPD includes SABA alone as needed; patients on tiotropium before the beginning of the study will continue tiotropium; patients on a different antimuscarinic drug before the beginning of the study will continue bronchodilating treatment with tiotropium; patients on a LABA before the beginning of the study, will continue bronchodilating treatment with tiotropium 9. Ability to perform reproducible spirometry. 10. Patient is a nonsmoker and has stopped smoking for at least one year. 11. 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

General 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 smokers in the previous year. Pulmonary 1. Patient has, in addition to COPD, any active, acute or chronic pulmonary disorder documented by history or physical examination. 2. 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. 3. Patient had an upper respiratory tract infection (URI) in the previous three weeks. General Medical 1. Patient is hypersensitive to tiotropium, fluticasone or their components. 2. Patient has a clinically significant, active disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary, or hematological systems, or has uncontrolled hypertension (>160/95), or an immunodeficiency, or an autoimmune disorder. 3. Patiens with glaucoma. 4. Patients with benign prostatic hypertrophy or other causes of urinary obstruction. 5. 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 1. Patient has taken the following medications: 1) Oral, intravenous, intramuscular, intra-articular or inhaled corticosteroids in the previous 4 weeks with the exception of nasal corticosteroids administered on a continuous basis. 2) Antibiotics for 7 consecutive days in the previous 4 weeks. 3) IV gammaglobulin or immunosuppressants in the previous 4 weeks. 4) Beta-receptor-blocking agents (including ocular preparations) in individuals known to be sensitive to these compounds in the previous two weeks. Procedural 1. Patient is unable to perform acceptable, reproducible spirometry, and peak flow measurements. 2. 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