AsthmaPhase 2NCT02148120
A Study to Evaluate the Acute Bronchodilator Effect of CHF1535 NEXThaler
A Phase 2 study testing Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg and Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 3 sites in United Kingdom.
Trial summary
The aim of the study is to demonstrate the non-inferiority in terms of acute bronchodilator effect between a single dose of CHF 1535 NEXThaler 200/6 µg and a single dose of CHF 1535 NEXThaler 100/6 µg at two dose levels in partially controlled and uncontrolled asthmatic patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg and Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Apr 2014to Oct 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's written informed consent obtained prior to any study-related procedures.
- Male or female aged between 18 and 65 years inclusive;
- Evidence for "partially controlled" or "uncontrolled" asthma;
- Medium daily dose of previous inhaled corticosteroids (ICS) treatment;
- FEV1 between 60% and 85% of the predicted normal values;
- A documented positive response to the reversibility test;
- Non-smokers or ex-smokers;
- A cooperative attitude and ability to be trained in the proper use of a DPI.
Who cannot join
- Pregnant or lactating women and all women physiologically capable of becoming pregnant not willing to use at least one acceptable method of contraception.
- Significant seasonal variation in asthma occurring or expected to occur during study participation;
- History of near fatal asthma, brittle asthma, accident and Emergency treatment or hospitalisation for asthma exacerbation in Intensive Care Unit within 1 year before screening;
- Occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening;
- Diagnosis of Chronic Obstructive Pulmonary Disease;
- History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency;
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- Diagnosis of restrictive lung disease;
- Patients treated with oral or parenteral corticosteroids in the previous 8 weeks;
- Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids;
- Allergy, sensitivity or intolerance to study drugs or excipients;
- Patients who received any investigational drug within the last 8 weeks before the screening;
- Patients taking any of the non-permitted concomitant medication;
- Subjects unlikely to comply with the study protocol;
- Any clinically relevant abnormal value or physical finding at screening;
- Significant medical history;
- Abnormal and clinically significant 12-lead electrocardiogram;
- Patients with low compliance of QVAR intake.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Hammersmith Medicines Research
London, NW10 7EW
Respiratory Clinical Trials, Hearth Lung Centre
London, W1G 8HU
Medicines Evaluation Unit
Manchester, M23 9QZ
About this study
Official title: A Phase II, Multicentre, Double-blind, Randomised, 5-way Crossover Study to Test the Non-inferiority of the Acute Bronchodilator Effect of CHF 1535 200/6 µg NEXThaler Versus CHF 1535 100/6 µg NEXThaler in Partially Controlled and Uncontrolled Adult Asthmatic Patients.
The aim of the study is to demonstrate the non-inferiority in terms of acute bronchodilator effect between a single dose of CHF 1535 NEXThaler 200/6 µg and a single dose of CHF 1535 NEXThaler 100/6 µg at two dose levels in partially controlled and uncontrolled asthmatic patients.
- Conditions
- Asthma
- Being tested
- Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg, Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µgDrug
Also called Foster NEXThaler
Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| CHF1535 NEXThaler 100/6, 1 puff | Active comparator | Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg Receives: Drug: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg |
| CHF1535 NEXThaler 100/6 µg, 4 puffs | Active comparator | Beclometasone Dipropionate 400 µg + Formoterol Fumarate 24 µg Receives: Drug: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg |
| CHF1535 NEXThaler 200/6 µg, 1 puff | Experimental | Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg Receives: Drug: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg |
| CHF1535 NEXThaler 200/6 µg, 4 puffs | Experimental | Beclometasone Dipropionate 800 µg + Formoterol Fumarate 24 µg Receives: Drug: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg |
| Placebo NEXThaler | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 Area under the curve
FEV1= Forced expiratory volume in the first second of expiration
Measured: until 12 h post dose
Secondary outcomes (4)
FEV1 peak
Maximum FEV1 value
Measured: until 12 h post dose
FVC area under the curve
FVC = Forced Vital Capacity
Measured: until 12 h post dose
FVC peak
Maximum FVC
Measured: until 12 h post dose
Adverse events
from the signature of the informed consent until the end of the study, the total duration depends on the duration of the run-in and wash-out periods.
Measured: over a period of 5 to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148120
- Sponsor's protocol ID
- CCD-01535BA1-01
- Status last verified
- Mar 2017
- First submitted
- 21 May 2014
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicentre, Double-blind, Randomised, 5-way Crossover Study to Test the Non-inferiority of the Acute Bronchodilator Effect of CHF 1535 200/6 µg NEXThaler Versus CHF 1535 100/6 µg NEXThaler in Partially Controlled and Uncontrolled Adult Asthmatic Patients.
- ClinicalTrials.gov ID
- NCT02148120
- Acronym / sponsor ID
- CCD-01535BA1-01
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 May 2014 (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 aim of the study is to demonstrate the non-inferiority in terms of acute bronchodilator effect between a single dose of CHF 1535 NEXThaler 200/6 µg and a single dose of CHF 1535 NEXThaler 100/6 µg at two dose levels in partially controlled and uncontrolled asthmatic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CHF1535 NEXThaler 100/6, 1 puff | Active comparator | Drug: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µgBeclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg |
| CHF1535 NEXThaler 100/6 µg, 4 puffs | Active comparator | Drug: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µgBeclometasone Dipropionate 400 µg + Formoterol Fumarate 24 µg |
| CHF1535 NEXThaler 200/6 µg, 1 puff | Experimental | Drug: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µgBeclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg |
| CHF1535 NEXThaler 200/6 µg, 4 puffs | Experimental | Drug: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µgBeclometasone Dipropionate 800 µg + Formoterol Fumarate 24 µg |
| Placebo NEXThaler | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient's written informed consent obtained prior to any study-related procedures.
- Male or female aged between 18 and 65 years inclusive;
- Evidence for "partially controlled" or "uncontrolled" asthma;
- Medium daily dose of previous inhaled corticosteroids (ICS) treatment;
- FEV1 between 60% and 85% of the predicted normal values;
Key exclusion criteria (17 listed)
- Pregnant or lactating women and all women physiologically capable of becoming pregnant not willing to use at least one acceptable method of contraception.
- Significant seasonal variation in asthma occurring or expected to occur during study participation;
- History of near fatal asthma, brittle asthma, accident and Emergency treatment or hospitalisation for asthma exacerbation in Intensive Care Unit within 1 year before screening;
- Occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening;
- Diagnosis of Chronic Obstructive Pulmonary Disease;
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 |
|---|---|---|
| Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µgAlso: Foster NEXThaler | Drug | CHF1535 NEXThaler 100/6 µg, 4 puffs, CHF1535 NEXThaler 100/6, 1 puff |
| Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg | Drug | CHF1535 NEXThaler 200/6 µg, 1 puff, CHF1535 NEXThaler 200/6 µg, 4 puffs |
| Placebo | Drug | Placebo NEXThaler |
Primary outcome
FEV1 Area under the curve
Time frame: until 12 h post dose
FEV1= Forced expiratory volume in the first second of expiration
4 secondary outcomes
FEV1 peak
Time frame: until 12 h post dose
FVC area under the curve
Time frame: until 12 h post dose
FVC peak
Time frame: until 12 h post dose
Adverse events
Time frame: over a period of 5 to 14 weeks
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 Mar 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg and Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 3 sites 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 8 inclusion and 17 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 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
FEV1 Area under the curve (time frame: until 12 h post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2017.