The study is focused on chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
Trade Name: Forair
Product Name: Forair
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: Formoterolhemifuarat
Concentration unit: µg microgram(s)
Concentration type: equal
Co
Sponsors
Chiesi farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 40 - 70 • Ability to properly use the MDI and DPI • Body weight resulting in a Body Mass Index (BMI) between 18.0 and 35 kg/m2 • Normal blood pressure and heart rate (supine SBP 100-140 mmHg, supine DBP 45-90 mmHg, heart rate 45-90 bpm). Minor deviations are acceptable provided that they are not judged relevant by the clinical investigator • Electrocardiogram (12 lead) with computerized protocol interpretation considered as normal (120ms ?PR? 220ms, QRS ?120ms, QTc ?450ms (male), ? 470 ms (female)). Minor deviations are acceptable provided that they are not judged relevant by the clinical investigator • Primary diagnosis of COPD (Diagnosis can be made during the screening process) • Moderate COPD (FEV1/FVC = 70 %, Stage III GOLD classification) documented at screening visit • Reversibility of FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before the first intake of study drug • Positive HIV1 or HIV2 serology • Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C • Unsuitable veins for repeated venipuncture • Female patients: pregnant, positive pregnancy test, lactating mother or lack of efficient contraception (according to CPMP/ICH 286/95 note 3 ). Postmenopausal women < 1 year must have efficient contraception • History of substance abuse or drug abuse within 12 months or with a positive urine drug screen • Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation • Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol • Participation in an investigational drug study within 30 days prior to Visit 1 or current participation in another investigational drug study • Known sensitivity to Formoterol, Salmeterol or Albuterol or any of the excipients contained in any of these formulations • Concomitant severe diseases or diseases which are contra indications for the use of inhaled ?2-agonist • Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation • Use of systemic steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 6 months • History of significant sensitivity or allergy to ?2-agonists or related drugs • Recent relevant infectious disease (less than two months) • Life-threatening/unstable respiratory status including upper or lower respiratory tract infection, within the previous 30 days • Requirement of continuous supplemental oxygen therapy; the use of supplemental oxygen may not exceed 2l/min, at night time only and/or only during exercise is allowed • Change in dose or type of any medications for COPD within 4 weeks prior to the screening visit • Use of any prescription drug for which concomitant beta-agonist administration is contraindicated • Exacerbation within the 4 weeks prior to inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to assess intrapulmonary deposition of two Formoterol formulations (FORAIR, Foradil P) in patients with COPD. ;Secondary Objective: Secondary objective is to describe pharmacokinetic properties of both drug formulations. ;Primary end point(s): • Intrapulmonary deposition (DL) | — |
Countries
Germany
Outcome results
None listed