COPDPhase 2NEXThalerNCT02000609
A Phase II, 5-way Cross-over Study to Evaluate the Pharmacodynamics of "Nexthaler" Dry Powder Inhaler in COPD Patients
A Phase 2 study testing CHF 1535 NEXThaler 800/48, CHF 1535 NEXThaler 200/12 and CHF 1535 pMDI 200/12 in people with COPD, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COPD
- What is being tested?
- CHF 1535 NEXThaler 800/48, CHF 1535 NEXThaler 200/12 and CHF 1535 pMDI 200/12
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2013to Apr 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II, Partial Blind, Randomized, Placebo Controlled, 5-way Cross-over Study to Evaluate the Pharmacodynamics of BDP(Beclomethasone Diproprionate)/B17MP (Beclomethasone-17-Monoproprionate) and FORMOTEROL FUMARATE (FF) Across Two Different Dose Levels of CHF 1535 NEXThaler DPI (Dry Powder Inhaler) and CHF 1535 pMDI (Pressurized Metered-dose Inhaler)in Adult COPD (Chronic Obstructive Pumonary Disease) Patients
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.
Read the detailed 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
- Conditions
- COPD
- Being tested
- CHF 1535 NEXThaler 800/48, CHF 1535 NEXThaler 200/12, CHF 1535 NEXThaler PLACEBO, CHF 1535 pMDI 200/12, CHF1535 pMDI 800/48
- Keywords
- pharmacodynamics COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF 1535 NEXThaler 800/48Drug
CHF 1535 NEXThaler 200/12Drug
CHF 1535 NEXThaler PLACEBODrug
CHF 1535 pMDI 200/12Drug
CHF1535 pMDI 800/48Drug
| Study group | Role | What they receive |
|---|---|---|
| CHF 1535 NEXThaler 800/48 ug | Active comparator | single dose administration of CHF 1535 100/6 NEXThaler DPI, total dose: 800ug BDP, 48 ug Formoterol Fumarate Receives: Drug: CHF 1535 NEXThaler 800/48 |
| CHF 1535 NEXThaler PLACEBO | Placebo comparator | single dose administration of placebo via NEXThaler DPI Receives: Drug: CHF 1535 NEXThaler PLACEBO |
| CHF 1535 pMDI 200/12 | Active comparator | single dose administration of CHF 1535 100/6 pMDI , total dose: 200 ug BDP, 12 ug Formoterol Fumarate Receives: Drug: CHF 1535 pMDI 200/12 |
| CHF 1535 100/6 pMDI 800/48 | Active comparator | single dose administration of CHF 1535 100/6 pMDI total dose: 800ug BDP, 48 ug Formoterol Fumarate Receives: Drug: CHF1535 pMDI 800/48 |
| CHF 1535 NEXThaler 200/12 | Active comparator | single dose administration of CHF 1535 100/6 pMDI, total dose: 200 ug BDP, 12 ug Formoterol Fumarate Receives: Drug: CHF 1535 NEXThaler 200/12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average 4-hour Heart Rate bpm (beats per minutes)
Measured: 4 hours
Secondary outcomes (1)
QTcF (QT interval Fridericia's formula corrected) (milliseconds), QRS (milliseconds) and PR (milliseconds) intervals, PAC (Premature Atrial Contraction- percentage) burden, PVC (Premature Ventricular Contraction-percentage) burden, Blood Pressure (mmHg)
Measured: -45, -30, -15min pre-dose, 5, 10, 20, 30, 45min, 1, 1.5, 2, 3, 4, 5, 5, 7, 8, 10 12 hr post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Singh, Principal investigator, Medicine Evaluation Unit, Manchester (UK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000609
- Sponsor's protocol ID
- CCD-01535BC1-02
- Acronym
- NEXThaler
- Status last verified
- Oct 2021
- First submitted
- 21 Nov 2013
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28065679
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Partial Blind, Randomized, Placebo Controlled, 5-way Cross-over Study to Evaluate the Pharmacodynamics of BDP(Beclomethasone Diproprionate)/B17MP (Beclomethasone-17-Monoproprionate) and FORMOTEROL FUMARATE (FF) Across Two Different Dose Levels of CHF 1535 NEXThaler DPI (Dry Powder Inhaler) and CHF 1535 pMDI (Pressurized Metered-dose Inhaler)in Adult COPD (Chronic Obstructive Pumonary Disease) Patients
- ClinicalTrials.gov ID
- NCT02000609
- Acronym / sponsor ID
- NEXThaler / CCD-01535BC1-02
- Conditions
- COPD
- Keywords
- pharmacodynamics COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CHF 1535 NEXThaler 800/48 ug | Active comparator | Drug: CHF 1535 NEXThaler 800/48single dose administration of CHF 1535 100/6 NEXThaler DPI, total dose: 800ug BDP, 48 ug Formoterol Fumarate |
| CHF 1535 NEXThaler PLACEBO | Placebo comparator | Drug: CHF 1535 NEXThaler PLACEBOsingle dose administration of placebo via NEXThaler DPI |
| CHF 1535 pMDI 200/12 | Active comparator | Drug: CHF 1535 pMDI 200/12single dose administration of CHF 1535 100/6 pMDI , total dose: 200 ug BDP, 12 ug Formoterol Fumarate |
| CHF 1535 100/6 pMDI 800/48 | Active comparator | Drug: CHF1535 pMDI 800/48single dose administration of CHF 1535 100/6 pMDI total dose: 800ug BDP, 48 ug Formoterol Fumarate |
| CHF 1535 NEXThaler 200/12 | Active comparator | Drug: CHF 1535 NEXThaler 200/12single dose administration of CHF 1535 100/6 pMDI, total dose: 200 ug BDP, 12 ug Formoterol Fumarate |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHF 1535 NEXThaler 800/48 | Drug | CHF 1535 NEXThaler 800/48 ug |
| CHF 1535 NEXThaler 200/12 | Drug | CHF 1535 NEXThaler 200/12 |
| CHF 1535 NEXThaler PLACEBO | Drug | CHF 1535 NEXThaler PLACEBO |
| CHF 1535 pMDI 200/12 | Drug | CHF 1535 pMDI 200/12 |
| CHF1535 pMDI 800/48 | Drug | CHF 1535 100/6 pMDI 800/48 |
Primary outcome
Average 4-hour Heart Rate bpm (beats per minutes)
Time frame: 4 hours
1 secondary outcome
QTcF (QT interval Fridericia's formula corrected) (milliseconds), QRS (milliseconds) and PR (milliseconds) intervals, PAC (Premature Atrial Contraction- percentage) burden, PVC (Premature Ventricular Contraction-percentage) burden, Blood Pressure (mmHg)
Time frame: -45, -30, -15min pre-dose, 5, 10, 20, 30, 45min, 1, 1.5, 2, 3, 4, 5, 5, 7, 8, 10 12 hr post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Results publication: PubMed 28065679Singh 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.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dave Singh principal investigator
Medicine Evaluation Unit, Manchester (UK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CHF 1535 NEXThaler 800/48, CHF 1535 NEXThaler 200/12 and CHF 1535 pMDI 200/12 in people with COPD, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average 4-hour Heart Rate bpm (beats per minutes) (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02000609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.