COPD MedDRA version: 14.0 Level: LLT Classification code 10009032 Term: Chronic obstructive lung disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Atimos® 12µg
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: Formoterol Fumarate
CAS Number: 43229-80-7
Sponsors
Chiesi Farmaceutici SpA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject’s written informed consent obtained prior to any study-related procedures 2. Male and female outpatients, aged = 40 years 3. Patients with a clinical diagnosis of COPD (according to GOLD guidelines) 4. Post bronchodilator (to salbutamol 400 micrograms inhalation pMDI as per GOLD guidelines) FEV1 between 30% and 80% predicted values (30% = FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Current or past diagnosis of asthma 2. Positive FEV1 reversibility test: ?FEV1 30 minutes following inhalation of 400 µg of salbutamol pMDI greater than 200 mL and 12% above the prebronchodilator FEV1 3. History of any chronic respiratory diseases other than COPD 4. History of another medical condition, which in the opinion of the Unit Physician, contraindicates his/her participation in the study. 5. Clinical evidence of heart failure (NYHA class III-IV) 6. Unstable respiratory disease in the last four weeks prior to the screening visit (indicated by any change in their maintenance inhaled therapy or who have had a lower respiratory tract infection in the previous four weeks) 7. Evidence of a respiratory exacerbation requiring emergency room treatment and/or hospitalisation within four weeks before screening. 8. Use of systemic (oral or intravenous) steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 12 months 9. Participants with a known or suspected allergy, sensitivity or intolerance to the study drugs or to long acting beta agonists, will be excluded from the study. 10. Patient with a contraindication to taking an inhaled long-acting beta-agonists, listed in the British National Formulary (BNF) 11. Patients treated with beta-blockers in the week preceding the screening visit and during the study period 12. Females who are pregnant or lactating or are likely to become pregnant during the trial. Women of childbearing potential may be included in the study if, in the opinion of the investigator, they are taking adequate contraceptive precautions. 13. Patients who have evidence of alcohol or substance abuse 14. Participation in another clinical trial with an investigational drug in the four weeks preceding the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of Formoterol compared to Salmeterol (HFA-pMDI) on small aiways physiological paramaters in patients with COPD.; Secondary Objective: to assess the safety and tolerability, as determined by the recording of vital signs [heart rate (HR), blood pressure (BP)], adverse events (AEs) and adverse drug reactions (ADRs). ;Primary end point(s): Lung Reactance (X5) from Impulse oscillometry (IOS) | — |
Countries
United Kingdom
Outcome results
None listed