AsthmaPhase 2CHF6001_POC2NCT01689571
A Study to Evaluate the Efficacy After Allergen Challenge, Safety and Tolerability of Inhaled CHF6001 DPI in Asthmatics
A Phase 2 study testing CHF6001 in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 3 sites in United Kingdom.
Trial summary
The study is designed to look at the safety, tolerability and efficacy of 2 different doses of the study drug (CHF6001, a PDE4 inhibitor) in asthmatics, when given by inhalation, once a day for 9 days. The efficacy will be evaluated by measuring the protective effect of CHF 6001 after an allergen challenge. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- CHF6001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Oct 2012to Apr 2013
- 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
- written informed consent obtained
- Non smoking or ex-smokers from at least 1 year prior to study entry
- Males of females between 18 and 60 years inclusive
- Body Mass Index between 18 and 32 kg/m2
- Ability to be trained about the proper use of the inhalation device and to perform spirometry
- With mild to moderate allergic asthma as defined by the GINA guideline, steroid naive
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- Atopy to at least one common aeroallergen
- Positive allergen-induced Early Asthmatic Response and Late Asthmatic Response at screening
- Ability to produce an adequate sputum sample
- Post-menopausal women, women of not childbearing potential or males and females of childbearing potential willing (they or their partner) to use a reliable method of contraception.
Who cannot join
- Worsening of asthma or respiratory tract infection prior to study entry
- History of life-threatening asthma or hospitalization for asthma prior to the study entry
- Pregnant or lactating women
- History of clinically significant hypotensive episodes or fainting, dizziness or light-headedness
- History or symptoms of clinically relevant neurologic disease
- Symptomatic hay fever
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- Unstable concurrent disease that may impact the feasibility of the study
- Use of systemic corticosteroids, nebulised bronchodilator or oral beta2-agonist
- Use of leukotrienes modifiers, roflumilast or cromoglycate
- Use of long acting beta2-agonist or inhaled corticosteroids
- Use of short-acting or long-acting non-sedatives antihistamines
- Use of any other medication for the treatment of allergic asthma other than salbutamol
- Having received an investigational medicinal drug within 30 days prior to study entry
- Blood drawn of at least 250 ml in the previous 45 days
- Ongoing use of tobacco
- Other lung disease
- Recent history of alcohol dependency
- Inability to comply with the study protocol
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Hammersmith Medicines Research
London
Respiratory Clinical Trials
London
Medicines Evaluation Unit
Manchester
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Three-way Crossover Study to Evaluate the Efficacy After Allergen Challenge, Safety and Tolerability of Two Doses of Inhaled CHF6001 DPI After 9 Days of Treatment in Adult Patients With Asthma
The study is designed to look at the safety, tolerability and efficacy of 2 different doses of the study drug (CHF6001, a PDE4 inhibitor) in asthmatics, when given by inhalation, once a day for 9 days. The efficacy will be evaluated by measuring the protective effect of CHF 6001 after an allergen challenge.
- Conditions
- Asthma
- Being tested
- CHF6001, Placebo
- Keywords
- PDE4 inhibitor, Allergen Challenge, Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF6001Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo DPI | Placebo comparator | Placebo by inhalation for 9 days Receives: Drug: Placebo |
| CHF6001 DPI Dose 2 | Experimental | CHF6001 by inhalation for 9 days Receives: Drug: CHF6001 |
| CHF6001 DPI Dose1 | Experimental | CHF6001 by inhalation for 9 days Receives: Drug: CHF6001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergen challenge
Measured: after 9 days of treatment
Secondary outcomes (2)
Induced Sputum
Measured: After 9 days of treatment
Methacholine challenge
Measured: After 9 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2013
- Study completionApr 2013
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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Singh, MD, Principal investigator, Medicines Evaluation UnitBrian Leaker, MD, Principal investigator, Respiratory Clinical TrialsElizabeth Tranter, MD, Principal investigator, Hammersmith Medicines Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689571
- Sponsor's protocol ID
- CCD-1202-PR-0080
- Other IDs
- 2012-001483-29
- Acronym
- CHF6001_POC2
- Status last verified
- Mar 2017
- First submitted
- 4 Sep 2012
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Three-way Crossover Study to Evaluate the Efficacy After Allergen Challenge, Safety and Tolerability of Two Doses of Inhaled CHF6001 DPI After 9 Days of Treatment in Adult Patients With Asthma
- ClinicalTrials.gov ID
- NCT01689571
- Acronym / sponsor ID
- CHF6001_POC2 / CCD-1202-PR-0080
- Conditions
- Asthma
- Keywords
- PDE4 inhibitor, Allergen Challenge, Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 21 Sep 2012 (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 is designed to look at the safety, tolerability and efficacy of 2 different doses of the study drug (CHF6001, a PDE4 inhibitor) in asthmatics, when given by inhalation, once a day for 9 days. The efficacy will be evaluated by measuring the protective effect of CHF 6001 after an allergen challenge.
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 |
|---|---|---|
| Placebo DPI | Placebo comparator | Drug: PlaceboPlacebo by inhalation for 9 days |
| CHF6001 DPI Dose 2 | Experimental | Drug: CHF6001CHF6001 by inhalation for 9 days |
| CHF6001 DPI Dose1 | Experimental | Drug: CHF6001CHF6001 by inhalation for 9 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- written informed consent obtained
- Non smoking or ex-smokers from at least 1 year prior to study entry
- Males of females between 18 and 60 years inclusive
- Body Mass Index between 18 and 32 kg/m2
- Ability to be trained about the proper use of the inhalation device and to perform spirometry
Key exclusion criteria (18 listed)
- Worsening of asthma or respiratory tract infection prior to study entry
- History of life-threatening asthma or hospitalization for asthma prior to the study entry
- Pregnant or lactating women
- History of clinically significant hypotensive episodes or fainting, dizziness or light-headedness
- History or symptoms of clinically relevant neurologic 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 |
|---|---|---|
| CHF6001 | Drug | CHF6001 DPI Dose 2, CHF6001 DPI Dose1 |
| Placebo | Drug | Placebo DPI |
Primary outcome
Allergen challenge
Time frame: after 9 days of treatment
2 secondary outcomes
Induced Sputum
Time frame: After 9 days of treatment
Methacholine challenge
Time frame: After 9 days of treatment
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 30 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.
Dave Singh, MD principal investigator
Medicines Evaluation Unit
Brian Leaker, MD principal investigator
Respiratory Clinical Trials
Elizabeth Tranter, MD principal investigator
Hammersmith Medicines Research
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 CHF6001 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 10 inclusion and 18 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 30 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?
Allergen challenge (time frame: after 9 days of treatment). 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 30 Mar 2017; AzTrials last refreshed its copy on 2 Nov 2026.