Moderate Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Product Name: gefitinib
Product Code: ZD1839
Pharmaceutical Form: Coated tablet
INN or Proposed INN: gefitinib
Current Sponsor code: ZD1839
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
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=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of gefitinib tablets, 250 mg once daily (OD) on symptoms, mainly cough and sputum production, in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to placebo during a 4-week treatment period;Secondary Objective: Assess the effect of gefitinib on lung function by assessing Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC), Vital Capacity (VC), and Inspiratory Capacity (IC), respiratory symptoms (other than cough) captured by questionnaires as well as recorded in diaries, and Peak Expiratory Flow (PEF). Assess safety by collecting nature, incidence and severity of Adverse Events (AEs) including obtaining Electrocardiogram (ECG), vital signs and laboratory safety assessments. Effect of phosphorylation of the Epidermal Growth Factor Receptor (EFGR) in bronchial biopsies will be measured in subgroup. Number of COPD exacerbations will be assessed at clinical visits in all patients.;Primary end point(s): The main outcome variable will be cough assessed by different symptom questions included in the following questionnaires; Diary: Clinical COPD Questionnaire (CCQ), Major Symptom questions. Visits: St. George's Respiratory Questionnaire (SGRQ), Community Acquired Pneumonia questionnaire (CAP). | — |
Countries
Denmark, Finland, Norway, Sweden
Outcome results
None listed