AsthmaPhase 2NCT01070524
Cross-over Study to Evaluate the Effect on Trough Forced Expiratory Volume in One Second (FEV1) After 4 Weeks Treatment With CHF 5188 pMDI qd in Adult Patients With Persistent Asthma
A Phase 2 study testing CHF 5188 pMDI, Budesonide extrafine pMDI and Seretide(r) Evohaler(r) in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
Trial summary
Cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with persistent asthma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- CHF 5188 pMDI, Budesonide extrafine pMDI and Seretide(r) Evohaler(r)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to Jul 2010
- 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
- Moderate or severe asthma partly controlled with ICS or ICS/LABA
- FEV1 ≥ 60% and ≤ 90% of predicted for the patient normal value
Who cannot join
- Diagnosis of COPD
- History or current evidence of significant cardiovascular disease
- Uncontrolled concomitant disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Medicines Evaluation Unit Ltd, The Langley Building, Southmoor Road
Manchester, M23 9QZ
About this study
Official title: A Randomised, Double-blind, Active-controlled, 3 Way Cross-over Study to Evaluate the Effect on Trough FEV1 After 4 Weeks Treatment With CHF 5188 pMDI qd (Fixed Combination Budesonide / Carmoterol) in Adult Patients With Moderate or Severe Persistent Asthma
Cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with persistent asthma
Read the detailed description
A randomised, double-blind, multinational, multicentre, active-controlled, 3-way cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with moderate or severe persistent asthma
- Conditions
- Asthma
- Being tested
- CHF 5188 pMDI, Budesonide extrafine pMDI, Seretide(r) Evohaler(r)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF 5188 pMDIDrug
CHF 5188: fixed combination budesonide/carmoterol
Budesonide extrafine pMDIDrug
Budesonide extrafine pMDI
Seretide(r) Evohaler(r)Drug
Seretide(r) Evohaler(r): fixed combination fluticasone/salmeterol
| Study group | Role | What they receive |
|---|---|---|
| CHF 5188 pMDI | Experimental | Not described Receives: Drug: CHF 5188 pMDI |
| Budesonide extrafine pMDI | Active comparator | Not described Receives: Drug: Budesonide extrafine pMDI |
| Seretide(r) Evohaler(r) | Active comparator | Not described Receives: Drug: Seretide(r) Evohaler(r) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough FEV1 (mean 23h-24h FEV1)
Measured: after day 28 dose
Secondary outcomes (4)
Trough FEV1 and forced vital capacity (FVC) (mean 23h-24h)
Measured: after day 1 dose
Trough FVC (mean 23-24h)
Measured: after day 28 dose
Peak FEV1 and FVC
Measured: on day 1 and day 28
FEV1 AUC0-24
Measured: after day 1 and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2010
- Study completionJul 2010
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
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dave Singh, MD, Principal investigator, The Medicines Evaluation Unit Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070524
- Sponsor's protocol ID
- CCD-0909-PR-0020
- Other IDs
- 2009-013759-32, 2009
- Status last verified
- Mar 2017
- First submitted
- 17 Feb 2010
- 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, Active-controlled, 3 Way Cross-over Study to Evaluate the Effect on Trough FEV1 After 4 Weeks Treatment With CHF 5188 pMDI qd (Fixed Combination Budesonide / Carmoterol) in Adult Patients With Moderate or Severe Persistent Asthma
- ClinicalTrials.gov ID
- NCT01070524
- Acronym / sponsor ID
- CCD-0909-PR-0020
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 18 Feb 2010 (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.
Cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with persistent asthma
Detailed description
A randomised, double-blind, multinational, multicentre, active-controlled, 3-way cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with moderate or severe persistent asthma
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 |
|---|---|---|
| CHF 5188 pMDI | Experimental | Drug: CHF 5188 pMDI |
| Budesonide extrafine pMDI | Active comparator | Drug: Budesonide extrafine pMDI |
| Seretide(r) Evohaler(r) | Active comparator | Drug: Seretide(r) Evohaler(r) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate or severe asthma partly controlled with ICS or ICS/LABA
- FEV1 ≥ 60% and ≤ 90% of predicted for the patient normal value
Key exclusion criteria (3 listed)
- Diagnosis of COPD
- History or current evidence of significant cardiovascular disease
- Uncontrolled concomitant 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 |
|---|---|---|
| CHF 5188 pMDICHF 5188: fixed combination budesonide/carmoterol | Drug | CHF 5188 pMDI |
| Budesonide extrafine pMDIBudesonide extrafine pMDI | Drug | Budesonide extrafine pMDI |
| Seretide(r) Evohaler(r)Seretide(r) Evohaler(r): fixed combination fluticasone/salmeterol | Drug | Seretide(r) Evohaler(r) |
Primary outcome
Trough FEV1 (mean 23h-24h FEV1)
Time frame: after day 28 dose
4 secondary outcomes
Trough FEV1 and forced vital capacity (FVC) (mean 23h-24h)
Time frame: after day 1 dose
Trough FVC (mean 23-24h)
Time frame: after day 28 dose
Peak FEV1 and FVC
Time frame: on day 1 and day 28
FEV1 AUC0-24
Time frame: after day 1 and day 28
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
The Medicines Evaluation Unit Ltd
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 5188 pMDI, Budesonide extrafine pMDI and Seretide(r) Evohaler(r) in people with 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 2 inclusion and 3 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 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. 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?
Trough FEV1 (mean 23h-24h FEV1) (time frame: after day 28 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 30 Mar 2017.