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About
The study aim is to compare the pharmacodynamic effects (cardiovascular effects- primary variable: Heart rate over 4 hours post dosing- ) after administration of BDP and formoterol administered as CHF 1535 100/6 NEXThaler DPI or CHF1535 pMDI at two different dose levels.
Full description
The effects of both formulations on serum potassium and serum glucose and the general safety and tolerability of study treatments will be also evaluated
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Inclusion criteria
Exclusion criteria
Pregnant or lactating female subjects.
Current diagnosis of Asthma (as defined by the current GINA (Global Initiative for Asthma guidelines 2012 (update), or history of allergic rhinitis.
COPD exacerbations requiring systemic steroids and /or antibiotics and/or oral or nebulized beta 2-agonists in the 4 weeks prior to screening and until randomization.
Lower Respiratory Tract Infection (LRTI) in the 4 weeks prior to screening and until randomization.
Patients with serum potassium levels < 3.5 mEq/L (milliequivalent per liter).
History of substance abuse or drug abuse within 12 months prior to screening visit.
Known respiratory disorders other than COPD including but not limited to α1 antitrypsin deficiency, active tuberculosis, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, restrictive lung disease and interstitial lung disease.
Intolerance or contra-indication to treatment with beta 2-agonists and/or inhaled corticosteroids or allergy to any component of the study treatments.
Patients treated with non-cardioselective β-blockers in the month preceding the screening visit or during the study period.
Patients who have clinically significant cardiovascular disease according to investigator's judgement. Thus includes but is not limited to:
An abnormal 12-lead ECG (QRS> 120 msec, PR> 220 msec, HR < 40 bpm, Heart Rate > 110 bpm) at screening or at randomization.
Patients whose electrocardiogram (12-lead ECG) shows QTcF >450 ms for males or QTcF > 470 ms for females at screening or at randomisation.
Patients whose DBP/SBP is higher than: DBP 90 mmHg or SBP 160 mmHg at screening or at randomization.
Primary purpose
Allocation
Interventional model
Masking
49 participants in 5 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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