Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University Hospital, Antwerp
With
AstraZeneca
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Patients with documented COPD based on the following criteria:
Smoking history of at least 10 pack-years and decreased Tiffeneau index (FEV1/(F)VC \< 0.70).
2. Patients should present severe COPD with an FEV1 between 50 and 30% of predicted (GOLD 3).
3. Male or female patients aged ≥ 40 years.
4. Patients should be treated according to GOLD guidelines before study start.
5. Patients with, in the opinion of the investigator, a co-operative attitude and ability to be trained to correctly use the TurbohalerR.
6. Maintained on stable respiratory medications for 6 weeks prior to visit 1.
7. Written informed consent obtained.
You may not be if
1. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator.
2. Inability to carry out pulmonary function testing.
3. A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
4. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study
5. A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
6. Cancer or any other chronic disease with poor prognosis and/or affecting patient status.
7. A history of thoracotomy with pulmonary resection.
8. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients.
9. History of alcohol or drug abuse.
10. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
11. Patients who received any investigational new drug within the last 4 weeks prior to the screening visit.
12. Patients treated with any non-permitted concomitant medication (see 7.2).
Clareo Health | Assess Particle Deposition and Acute Effects of Symbicort® Forte Turbohaler®) in COPD Patients.
