A 4-week randomized, double-blind, placebo controlled, parallel group, phase II study to assess the efficacy and safety of gefitinib tablets, 250 mg once daily (OD), in adult patients with moderate chronic obstructive pulmonary disease (COPD) - GECO

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

1. Out-patients, men or post menopausal or surgically sterile women =40-=80years of age.
2. A clinical diagnosis of COPD with symptoms for at least 2 years (GOLD 2003 guidelines) prior to Visit 1.
3. A history of chronic cough with sputum production during the last year prior to Visit 1.
4. FEV1/VC<70% at Visit 1.
5. Post-bronchodilator FEV1=50-<80% of PN at Visit 1.
6. Current or previous smoker with a smoking history equivalent to 10 or more pack years.
7. Provision of Informed Consent Form could be obtained at an information visit prior to Visit 1 or at Visit 1 (according to local regulations), but before any study related procedures had been performed.
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

1. A history of asthma (in accordance with GINA 2002 guidelines).
2. History of allergic rhinitis.
3. Use of oral and/or inhaled GCS within 1 month prior to visit 1.
4. Women of childbearing potential.
5. Any current respiratory tract disorders other than COPD, which is considered by the investigator to be clinically significant.
6. Patients with a history of concurrent idiopathic pulmonary fibrosis/interstitial pneumonia/pneumoconiosis/radiation pneumonia/drug-induced pneumonia.
7. Exacerbation of COPD within 30 days prior to visit 1 requiring hospitalisation, a course of antibiotics and/or a course of increased doses of oral and/or inhaled GCS and/or parenteral treatment and/or nebulized treatment.
8. Drug allergy of any kind.
9. Patients currently treated with warfarin, or patients who have been treated with warfarin within 3 months prior to Visit 1.
10. Patients with liver transaminases, or bilirubin elevated above upper limit of normal (ULN) should not be included in the study.
11. Patients suffering from albuminuri (=2, or equiv.) and/or hematuria should not be included in the study.
12. Gastrointestinal infections or disease during the last 1 month prior to Visit 1.
13. A marked baseline prolongation of QT/QTc (eg, repeated demonstrations of a QTc interval >450 ms for females and >430 ms for males).
14. A history of additional risk factors for Torsade de pointes (eg. heart failure, hypokalemia, family history of Long QT syndrome).
15. The use concomitant medications that prolong the QT/QTc interval other than albuterol and terbutaline.
16. Use of oral or ophthalmic non-cardioselective beta-blocking agents.
17. Body Mass Index (BMI) <18 kg/m2.
18. Weight<50 kg.
19. Significant or unstable ischaemic heart disease, arrhytmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator.
20. Any significant disease or disorder (eg gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) or abnormal laboratory tests which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patients ability to participate.
21. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at Visit 1, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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