Chronic Obstructive Pulmonary Disease
Conditions
Interventions
investigational material(s)
Generic name etc : Formoterol Turbuhaler
INN of investigational material :
Therapeutic category code : 225 Bronchodilators
Dosage and Administration for Investigational m
Sponsors
AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Accepts Healthy Volunteers: No -Males or females aged above 40 with a clinical diagnosis of COPD and current COPD symptoms -Current or previous smoker with a smoking history of 10 or more pack years -Lung function parameters: FEV1/FVC < 70%, post-bronchodilator and post-bronchodilator FEV1 < 80% of predicted normal value
Exclusion criteria
Exclusion criteria: -History and/or current clinical diagnosis of asthma or atopic diseases such as allergic rhinitis -Use of inhaled glucocorticosteroids within 4 weeks prior to eligibility evaluation -Any relevant cardiovascular disorder as judged by the investigator or any current respiratory tract disorder other than COPD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To show that formoterol 4.5 microgram and 9 microgram twice daily are superior to placebo in Japanese and European COPD patients treated for 12 weeks by evaluation of FEV1 60 minutes post-dose [ Time Frame: evaluated 60 minutes post-dose at each visit for 12 weeks ] [ Designated as safety issue: No ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the onset of action of formoterol 4.5 microgram and 9 microgram using placebo as a control, by evaluation of FEV1 as the primary objective [ Time Frame: Evaluated 5 minutes post-dose at Visit 3 ] [ Designated as safety issue: No ] Compare the effect of formoterol 4.5 microgram twice daily to that of formoterol 9 microgram twice daily by evaluation of the same primary and secondary variables as for the primary objective [ Time Frame: evaluated at each visit for 12 weeks ] [ Designated as safety issue: No ] Evaluate the safety of formoterol 4.5 microgram and 9 microgram twice daily for 12 weeks in terms of: - Adverse events, laboratory variables, 12-lead ECG, blood pressure and pulse rate [ Time Frame: evaluated at each visit for 12 weeks ] [ Designated as safety issue: No ] | — |
Outcome results
None listed