Severe Eosinophilic AsthmaPhase 2NCT02560610
Effect of OC000459 on Eosinophilic Airway Inflammation in Severe Asthma
A Phase 2 study testing OC000459 in people with Severe Eosinophilic Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
Trial summary
The aim is to study the effect of OC000459 on eosinophilic airway inflammation and asthma control in subjects with severe, refractory eosinophilic asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Eosinophilic Asthma
- What is being tested?
- OC000459
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to 2 Aug 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Show evidence of reversible airflow obstruction documented within the previous 12 months or prior to Randomisation.
- Meet the European Respiratory Society/American Thoracic Society (ERS/ATS) criteria for severe asthma at Screening.
- Have documented evidence of eosinophilic airway inflammation during the 12 months prior to Screening.
- Have evidence of eosinophilic airway inflammation at Screening as reflected by an induced sputum eosinophil count of ≥3%.
- Subjects who are taking oral corticosteroids (OCS) must be receiving a 20 mg prednisolone equivalent dose, or less, daily for at least four weeks before the first dose of study drug. The dose of OCS should be unchanged for at least 14 days prior to the Baseline visit.
Who cannot join
- Treatment with XolairTM or anti-Th2 biologicals within 6 months prior to screening.
- Subjects with clinically significant abnormal serum biochemistry, haematology and urine examination values
- Subjects who have been hospitalised in the last 3 months.
- History of more than 2 episodes of confirmed bacterial lower respiratory tract infection or current lower respiratory tract infection.
- Subjects are current smokers or have a smoking history of >15 pack years.
- Significant comorbidity that in the Investigator's opinion is likely to impact the subject's participation in a 26 week study.
- Presence of a clinically important lung condition other than asthma, malignancy or previous history of cancer in remission for less than 12 months, clinically important liver or kidney disease, uncontrolled clinically significant cardiovascular disease, hypereosinophilic syndromes such as Churg-Strauss Syndrome or eosinophilic oesophagitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of OC000459 on Eosinophilic Airway Inflammation and Asthma Control in Subjects With Refractory Eosinophilic Asthma: a Randomised, Double-blind, Placebo Controlled Trial
The aim is to study the effect of OC000459 on eosinophilic airway inflammation and asthma control in subjects with severe, refractory eosinophilic asthma.
Read the detailed description
At week 12 subjects not on oral corticosteroids (OCS) will complete the treatment period and return after 4 weeks for final follow up visit. Those subjects who were taking OCS at baseline will continue for a maximum of 12 additional weeks, double blind period during which their current OCS treatment will be titrated down according to their clinical response.
- Conditions
- Severe Eosinophilic Asthma
- Being tested
- OC000459, Placebo
- Medical subject headings
- Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OC000459Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| OC000459 | Active comparator | Once daily dose of 50mg OC000459 tablets orally for 12/24 weeks Receives: Drug: OC000459 |
| Placebo | Placebo comparator | Once daily dose of placebo tablets orally for 12/24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the effect of OC000459 50mg given once daily with placebo on the induced sputum eosinophil counts.
Measured: Mean change from baseline and week 12
Secondary outcomes (4)
The effect on pre- and post-bronchodilator spirometry using forced expiratory volume in one second (FEV1).
Measured: Every 4 weeks up to week 12
The effect of OC000459 on fractional exhaled nitric oxide (FeNO).
Measured: At 4,8 and 12 weeks
Measuring quality of life using standardised asthma quality of life questionnaire (AQLQ(S)).
Measured: At weeks 4,8 and 12
Statistical comparison from baseline on induced sputum eosinophil count.
Measured: At weeks 4,8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startSep 2016
- Primary completion2 Aug 2018
- Study completion2 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Eosinophilic 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atopix Therapeutics, Ltd.
- Responsible party
- Sponsor
- Investigators
- Ian Pavord, Professor, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560610
- Sponsor's protocol ID
- OC000459/019/15
- Other IDs
- 2015-001833-26, 2015
- Status last verified
- Aug 2019
- First submitted
- 4 Sep 2015
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of OC000459 on Eosinophilic Airway Inflammation and Asthma Control in Subjects With Refractory Eosinophilic Asthma: a Randomised, Double-blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02560610
- Acronym / sponsor ID
- OC000459/019/15
- Conditions
- Severe Eosinophilic Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- Atopix Therapeutics, Ltd.
- Study start
- Sep 2016 (actual)
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 2 Aug 2018 (actual)
- First posted
- 25 Sep 2015 (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 is to study the effect of OC000459 on eosinophilic airway inflammation and asthma control in subjects with severe, refractory eosinophilic asthma.
Detailed description
At week 12 subjects not on oral corticosteroids (OCS) will complete the treatment period and return after 4 weeks for final follow up visit. Those subjects who were taking OCS at baseline will continue for a maximum of 12 additional weeks, double blind period during which their current OCS treatment will be titrated down according to their clinical response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OC000459 | Active comparator | Drug: OC000459Once daily dose of 50mg OC000459 tablets orally for 12/24 weeks |
| Placebo | Placebo comparator | Drug: PlaceboOnce daily dose of placebo tablets orally for 12/24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Show evidence of reversible airflow obstruction documented within the previous 12 months or prior to Randomisation.
- Meet the European Respiratory Society/American Thoracic Society (ERS/ATS) criteria for severe asthma at Screening.
- Have documented evidence of eosinophilic airway inflammation during the 12 months prior to Screening.
- Have evidence of eosinophilic airway inflammation at Screening as reflected by an induced sputum eosinophil count of ≥3%.
- Subjects who are taking oral corticosteroids (OCS) must be receiving a 20 mg prednisolone equivalent dose, or less, daily for at least four weeks before the first dose of study drug. The dose of OCS should be unchanged for at least 14 days prior to the Baseline visit.
Key exclusion criteria (7 listed)
- Treatment with XolairTM or anti-Th2 biologicals within 6 months prior to screening.
- Subjects with clinically significant abnormal serum biochemistry, haematology and urine examination values
- Subjects who have been hospitalised in the last 3 months.
- History of more than 2 episodes of confirmed bacterial lower respiratory tract infection or current lower respiratory tract infection.
- Subjects are current smokers or have a smoking history of >15 pack years.
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 |
|---|---|---|
| OC000459 | Drug | OC000459 |
| Placebo | Drug | Placebo |
Primary outcome
Compare the effect of OC000459 50mg given once daily with placebo on the induced sputum eosinophil counts.
Time frame: Mean change from baseline and week 12
4 secondary outcomes
The effect on pre- and post-bronchodilator spirometry using forced expiratory volume in one second (FEV1).
Time frame: Every 4 weeks up to week 12
The effect of OC000459 on fractional exhaled nitric oxide (FeNO).
Time frame: At 4,8 and 12 weeks
Measuring quality of life using standardised asthma quality of life questionnaire (AQLQ(S)).
Time frame: At weeks 4,8 and 12
Statistical comparison from baseline on induced sputum eosinophil count.
Time frame: At weeks 4,8 and 12
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 Aug 2019.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ian Pavord, Professor principal investigator
University of Oxford
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 OC000459 in people with Severe Eosinophilic Asthma, 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 7 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 Aug 2019. 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?
Compare the effect of OC000459 50mg given once daily with placebo on the induced sputum eosinophil counts. (time frame: Mean change from baseline and week 12). 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 Aug 2019.