A Phase II, 5-way Cross-over Study to Evaluate the Pharmacodynamics of "Nexthaler" Dry Powder Inhaler in COPD Patients
Study Identifier:
CCD-01535BC1-02
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete
Trial Documents
Clinical Study Report
Available Languages: English
Study Details
Medical Condition
- Chronic Obstructive Pulmonary Disease
Study Drug
- Drug: CHF 1535 NEXThaler 800/48
- Drug: CHF 1535 NEXThaler 200/12
- Drug: CHF 1535 NEXThaler PLACEBO
- Drug: CHF 1535 pMDI 200/12
- Drug: CHF1535 pMDI 800/48
Date
Dec 2013 - Apr 2014
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 40 - 75 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Male and female adults (≥ 40 and ≤ 75 years old).
- Outpatients with diagnosis of moderate/severe stable COPD, according to GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines update 2013 at least in the 6 months before the screening visit.
- A post-bronchodilator FEV1(Forced Expiratory Volume in one second) ≥ 40 and \< 80% of the predicted normal value and FEV1/FVC (Forced Vital Capacity) \< 0.7, after 4 puffs (4 x 100 µg) of salbutamol pMDI. If this criterion is not met at screening, the test can be repeated once before commencing of the run-in period.
- Ability to use pMDI (pressured metered-dose inhaler)and DPI (dry powder Inhaler) devices
- Current or past smoker of at least 10 pack/years where one pack-year is equivalent to 20 cigarettes per day for 1 year
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:
- congestive heart failure (NYHA class \> 3);
- acute ischemic heart disease within the past 12 months of screening;
- Sustained cardiac arrhythmias (supraventricular or ventricular, \>30 seconds duration) at or within 6 months of screening;
- Non sustained cardiac arrhythmias (supraventricular or ventricular, \> 3 beats \< 30 seconds and or ending spontaneously and or asymptomatic);
- History of sustained and non-sustained cardiac arrhythmias (supraventricular or ventricular);
- 2nd or 3rd degree Atrioventricular conduction block;
- Left Bundle Branch Block.
- 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.
Healthy Volunteers
No
Protocol Summary
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.
Study Locations
Location
Status
Location
Medicine Evaluation Unit
Manchester, United Kingdom, M239Qz
Status
N/A