AsthmaPhase 2NCT03108534
A Study to Evaluate the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 NEXThaler in Asthmatic Patients.
A Phase 2 study testing CHF1535 NEXThaler and CHF1535 pMDI in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 3 sites in United Kingdom.
Trial summary
The clinical trial is designed to evaluate the non-inferiority of CHF1535 100/6 µg NEXThaler versus CHF1535 100/6 µg pMDI on the onset of relief from methacholine-induced bronchospasm, in terms of pulmonary function (i.e. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- CHF1535 NEXThaler and CHF1535 pMDI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 28 Feb 2017to 19 Sep 2017
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent form obtained
- Minimum required Peak Inspiratory Flow (PIF) to activate NEXThaler
- Pre-bronchodilator FEV1 of at least 65%
- Positive response to methacholine challenge test
- Previous treatment with low-medium doses of Inhaled Corticosteroids (ICS) or ICS/Long-acting beta2-agonist (LABA) as per Global Initiative for Asthma (GINA) 2016 guidelines
- For females: non-pregnant, non-lactacting and using highly effective contraceptive methods.
Who cannot join
- Clinically relevant and uncontrolled concomitant diseases
- Abnormal clinically relevant ECG
- Presence of aortic aneurism
- Uncontrolled hypertension
- Intake of non-permitted concomitant medications
- Participation in another clinical trials in the previous 8 weeks
Show all 12Show fewer
- Seasonal variation in asthma
- Recent occurrence of asthma exacerbations
- Hypersensitivity to any product used in the trial, including excipients
- Heavy caffeine drinkers
- History of alcohol/drug abuse
- Smokers
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
University of Dundee
Dundee
Hammersmith Medicines Research
London
Medicines Evaluation Unit
Manchester
About this study
Official title: A Single Dose, Randomised, Double Blind, Double Dummy, Placebo Controlled, 3-way Crossover Clinical Study, Comparing the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 100/6 µg NEXThaler® Versus CHF1535 100/6 µg pMDI in Asthmatic Patients.
The clinical trial is designed to evaluate the non-inferiority of CHF1535 100/6 µg NEXThaler versus CHF1535 100/6 µg pMDI on the onset of relief from methacholine-induced bronchospasm, in terms of pulmonary function (i.e. change in Forced Expiratory Volume in the 1st second, FEV1, from baseline to 5 min after study drug intake) in asthmatic patients.
- Conditions
- Asthma
- Being tested
- CHF1535 NEXThaler, CHF1535 pMDI, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF1535 NEXThalerDrug
Also called Foster NEXThaler
Rescue treatment
CHF1535 pMDIDrug
Also called Foster
Rescue treatment
PlaceboDrug
Rescue treatment
| Study group | Role | What they receive |
|---|---|---|
| CHF1535 NEXThaler | Experimental | CHF1535 100/6 NEXThaler (Beclometasone dipropionate 100 µg + formoterol fumarate 6 µg) Receives: Drug: CHF1535 NEXThaler |
| CHF1535 pMDI | Active comparator | CHF1535 100/6 pMDI (Beclometasone dipropionate 100 µg + formoterol fumarate 6 µg) Receives: Drug: CHF1535 pMDI |
| Placebo | Placebo comparator | Double dummy study: placebo is for both CHF1535 pMDI and CHF1535 NEXThaler Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1 5-min post-dose
Change in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)
Measured: 5 min post-dose
Secondary outcomes (5)
Change in FEV1 other time points
Change in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)
Measured: Up to 30 min post-dose
FEV1 AUC0-10min
FEV1 area under the curve from dosing to 10 min post-dose
Measured: From dosing to 10 min post-dose
Time to recovery in FEV1
Time to return to 85% of baseline value
Measured: From dosing to 30 min post-dose
Change in Borg scale
Change in Borg scale from the end of the methacholine challenge test
Measured: Up to 30 min post-dose
Time to recovery in Borg scale
50% decrease from the post-methacholine challenge value
Measured: Up to 30 min post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start28 Feb 2017
- Primary completion19 Sep 2017
- Study completion19 Sep 2017
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
- 65 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
- NCT03108534
- Sponsor's protocol ID
- CCD-01535BD1-01
- Other IDs
- 2016-003672-47, 2016
- Status last verified
- Oct 2018
- First submitted
- 5 Apr 2017
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Randomised, Double Blind, Double Dummy, Placebo Controlled, 3-way Crossover Clinical Study, Comparing the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 100/6 µg NEXThaler® Versus CHF1535 100/6 µg pMDI in Asthmatic Patients.
- ClinicalTrials.gov ID
- NCT03108534
- Acronym / sponsor ID
- CCD-01535BD1-01
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 19 Sep 2017 (actual)
- Study completion
- 19 Sep 2017 (actual)
- First posted
- 11 Apr 2017 (actual)
- 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 clinical trial is designed to evaluate the non-inferiority of CHF1535 100/6 µg NEXThaler versus CHF1535 100/6 µg pMDI on the onset of relief from methacholine-induced bronchospasm, in terms of pulmonary function (i.e. change in Forced Expiratory Volume in the 1st second, FEV1, from baseline to 5 min after study drug intake) in asthmatic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHF1535 NEXThaler | Experimental | Drug: CHF1535 NEXThalerCHF1535 100/6 NEXThaler (Beclometasone dipropionate 100 µg + formoterol fumarate 6 µg) |
| CHF1535 pMDI | Active comparator | Drug: CHF1535 pMDICHF1535 100/6 pMDI (Beclometasone dipropionate 100 µg + formoterol fumarate 6 µg) |
| Placebo | Placebo comparator | Drug: PlaceboDouble dummy study: placebo is for both CHF1535 pMDI and CHF1535 NEXThaler |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Informed consent form obtained
- Minimum required Peak Inspiratory Flow (PIF) to activate NEXThaler
- Pre-bronchodilator FEV1 of at least 65%
- Positive response to methacholine challenge test
- Previous treatment with low-medium doses of Inhaled Corticosteroids (ICS) or ICS/Long-acting beta2-agonist (LABA) as per Global Initiative for Asthma (GINA) 2016 guidelines
Key exclusion criteria (12 listed)
- Clinically relevant and uncontrolled concomitant diseases
- Abnormal clinically relevant ECG
- Presence of aortic aneurism
- Uncontrolled hypertension
- Intake of non-permitted concomitant medications
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 |
|---|---|---|
| CHF1535 NEXThalerAlso: Foster NEXThalerRescue treatment | Drug | CHF1535 NEXThaler |
| CHF1535 pMDIAlso: FosterRescue treatment | Drug | CHF1535 pMDI |
| PlaceboRescue treatment | Drug | Placebo |
Primary outcome
Change in FEV1 5-min post-dose
Time frame: 5 min post-dose
Change in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)
5 secondary outcomes
Change in FEV1 other time points
Time frame: Up to 30 min post-dose
FEV1 AUC0-10min
Time frame: From dosing to 10 min post-dose
Time to recovery in FEV1
Time frame: From dosing to 30 min post-dose
Change in Borg scale
Time frame: Up to 30 min post-dose
Time to recovery in Borg scale
Time frame: Up to 30 min 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 4 Oct 2018.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases
Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)
RecruitingObservational study
Swiss Severe Asthma Register
Severe Asthma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
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 CHF1535 NEXThaler and CHF1535 pMDI 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 6 inclusion and 12 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 4 Oct 2018. 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?
Change in FEV1 5-min post-dose (time frame: 5 min 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 4 Oct 2018.