A Phase II, 5-way Cross-over Study to Evaluate the Pharmacodynamics of "Nexthaler" Dry Powder Inhaler in COPD Patients
NCT ID: NCT02000609
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2013-12-31
2014-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CHF 1535 NEXThaler 800/48 ug
single dose administration of CHF 1535 100/6 NEXThaler DPI, total dose: 800ug BDP, 48 ug Formoterol Fumarate
CHF 1535 NEXThaler 800/48
CHF 1535 NEXThaler PLACEBO
single dose administration of placebo via NEXThaler DPI
CHF 1535 NEXThaler PLACEBO
CHF 1535 pMDI 200/12
single dose administration of CHF 1535 100/6 pMDI , total dose: 200 ug BDP, 12 ug Formoterol Fumarate
CHF 1535 pMDI 200/12
CHF 1535 100/6 pMDI 800/48
single dose administration of CHF 1535 100/6 pMDI total dose: 800ug BDP, 48 ug Formoterol Fumarate
CHF1535 pMDI 800/48
CHF 1535 NEXThaler 200/12
single dose administration of CHF 1535 100/6 pMDI, total dose: 200 ug BDP, 12 ug Formoterol Fumarate
CHF 1535 NEXThaler 200/12
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CHF 1535 NEXThaler 800/48
CHF 1535 NEXThaler 200/12
CHF 1535 NEXThaler PLACEBO
CHF 1535 pMDI 200/12
CHF1535 pMDI 800/48
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
40 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dave Singh
Role: PRINCIPAL_INVESTIGATOR
Medicine Evaluation Unit, Manchester (UK)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medicine Evaluation Unit
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Singh D, Ciurlia G, Piccinno A, Muraro A, Bocchi M, Scuri M. Acute cardiovascular safety of two formulations of beclometasone dipropionate/formoterol fumarate in COPD patients: A single-dose, randomised, placebo-controlled crossover study. Pulm Pharmacol Ther. 2017 Feb;42:43-51. doi: 10.1016/j.pupt.2016.12.004. Epub 2017 Jan 5.
Related Links
Access external resources that provide additional context or updates about the study.
Study Record on EU Clinical Trials Register including results
CSR Synopsis available in the CHIESI Clinical Study Register
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CCD-01535BC1-02
Identifier Type: -
Identifier Source: org_study_id