AsthmaPhase 2NCT00868023
Next DPI LABA, Multicentre, 5-way Cross-over, Adult Asthmatic Patients
A Phase 2 study testing CHF 1535 Next DPI and Foster BDP/Formoterol in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
Trial summary
Multinational, multicentre, randomised, double blind, double dummy, placebo and active controlled, 5-way cross over 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 1535 Next DPI and Foster BDP/Formoterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2009to Oct 2009
- 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
- Patient's written informed consent obtained prior to any study-related procedures.
- Outpatient male or female aged ≥ 18 years.
- Evidence for "partly controlled" asthma in the 2 weeks before the screening visit
- Under previous inhaled corticosteroids (ICS) treatment at the screening visit
- Forced expiratory volume in the first second (FEV1) ≥ 60% and ≤ 90% of the predicted normal values at the screening visit.
- A documented positive response to the reversibility test at the screening visit, defined as ΔFEV1 ≥ 12% and ≥ 200 mL over baseline, 30 minutes after 400 μg salbutamol pMDI
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- Patients free of long-acting beta2-agonists (LABAs) treatment for at least 2 weeks before the screening visit.
- Patients free of short-acting beta2-agonists (SABAs) treatment for at least 6 hours before the screening visit.
- Non-smokers or ex-smokers
Who cannot join
- Pregnant or lactating women or all women physiologically capable of becoming pregnant UNLESS they are menopausal or are using effective and acceptable methods of contraception.
- Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer.
- History of near fatal asthma (e.g. brittle asthma, 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 visit.
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- 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 (12 weeks for parenteral depot corticosteroids) before screening visit.
- Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids.
- Allergy, sensitivity or intolerance to study drugs or excipients.
- Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Multinational, Multicentre, Double Blind, Double Dummy, Randomised, 5-way Cross-over, Placebo and Active Controlled Clinical Study to Test the Non-inferiority of a Single Dose of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate 100 µg Plus Formoterol Fumarate 6 µg Dry Powder) Via NEXT™ DPI 1 or 4 Inhalations Versus CHF 1535 (Beclomethasone Dipropionate 100 µg Plus Formoterol Fumarate 6 µg) pMDI With HFA-134a Propellant 1 or 4 Puffs on FEV1 AUC0-12h in Partly Controlled Adult Asthmatic Patients
Multinational, multicentre, randomised, double blind, double dummy, placebo and active controlled, 5-way cross over
Read the detailed description
To demonstrate the non-inferiority in terms of FEV1 AUC0-12h between a single dose of CHF 1535 via NEXT DPI and CHF 1535 via HFA-134a "extrafine" pMDI in partly controlled adult asthmatic patients
- Conditions
- Asthma
- Being tested
- CHF 1535 Next DPI, Foster BDP/Formoterol, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF 1535 Next DPIDrug
CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)
Foster BDP/FormoterolDrug
BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)
CHF 1535 Next DPIDrug
CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg)
Foster BDP/FormoterolDrug
BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CHF 1535 DPI : BDP/Formo 400/24 µg Receives: Drug: CHF 1535 Next DPI |
| 2 | Active comparator | CHF 1535 pMDI HFA : BDP/Formo 400/24 µg Receives: Drug: Foster BDP/Formoterol |
| 3 | Experimental | CHF 1535 DPI : BDP/Formo 100/6 µg Receives: Drug: CHF 1535 Next DPI |
| 4 | Active comparator | CHF 1535 pMDI HFA : BDP/Formo 100/6 µg Receives: Drug: Foster BDP/Formoterol |
| 5 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 AUC0-12h
Measured: Every week
Secondary outcomes (1)
FVC as assessed at the same time points as for FEV1; Peak FEV1 in terms of absolute values and % of change from baseline Safety evaluation
Measured: Every week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
- Study completionOct 2009
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Singh, Professor, Principal investigator, Medecines Evaluation Unit - Southmoor Road - M23 9QZ Manchester - UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868023
- Sponsor's protocol ID
- CCD-0809-PR-0038
- Other IDs
- 2008-004842-10, 2008
- Status last verified
- Mar 2017
- First submitted
- 23 Mar 2009
- 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 Phase II, Multinational, Multicentre, Double Blind, Double Dummy, Randomised, 5-way Cross-over, Placebo and Active Controlled Clinical Study to Test the Non-inferiority of a Single Dose of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate 100 µg Plus Formoterol Fumarate 6 µg Dry Powder) Via NEXT™ DPI 1 or 4 Inhalations Versus CHF 1535 (Beclomethasone Dipropionate 100 µg Plus Formoterol Fumarate 6 µg) pMDI With HFA-134a Propellant 1 or 4 Puffs on FEV1 AUC0-12h in Partly Controlled Adult Asthmatic Patients
- ClinicalTrials.gov ID
- NCT00868023
- Acronym / sponsor ID
- CCD-0809-PR-0038
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 24 Mar 2009 (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.
Multinational, multicentre, randomised, double blind, double dummy, placebo and active controlled, 5-way cross over
Detailed description
To demonstrate the non-inferiority in terms of FEV1 AUC0-12h between a single dose of CHF 1535 via NEXT DPI and CHF 1535 via HFA-134a "extrafine" pMDI in partly controlled adult asthmatic patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CHF 1535 Next DPICHF 1535 DPI : BDP/Formo 400/24 µg |
| 2 | Active comparator | Drug: Foster BDP/FormoterolCHF 1535 pMDI HFA : BDP/Formo 400/24 µg |
| 3 | Experimental | Drug: CHF 1535 Next DPICHF 1535 DPI : BDP/Formo 100/6 µg |
| 4 | Active comparator | Drug: Foster BDP/FormoterolCHF 1535 pMDI HFA : BDP/Formo 100/6 µg |
| 5 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient's written informed consent obtained prior to any study-related procedures.
- Outpatient male or female aged ≥ 18 years.
- Evidence for "partly controlled" asthma in the 2 weeks before the screening visit
- Under previous inhaled corticosteroids (ICS) treatment at the screening visit
- Forced expiratory volume in the first second (FEV1) ≥ 60% and ≤ 90% of the predicted normal values at the screening visit.
Key exclusion criteria (11 listed)
- Pregnant or lactating women or all women physiologically capable of becoming pregnant UNLESS they are menopausal or are using effective and acceptable methods of contraception.
- Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer.
- History of near fatal asthma (e.g. brittle asthma, 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 visit.
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
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 1535 Next DPICHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg) | Drug | 1 |
| Foster BDP/FormoterolBDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg) | Drug | 2 |
| CHF 1535 Next DPICHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg) | Drug | 3 |
| Foster BDP/FormoterolBDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg | Drug | 4 |
| PlaceboPlacebo | Drug | 5 |
Primary outcome
FEV1 AUC0-12h
Time frame: Every week
1 secondary outcome
FVC as assessed at the same time points as for FEV1; Peak FEV1 in terms of absolute values and % of change from baseline Safety evaluation
Time frame: Every week
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.
David Singh, Professor principal investigator
Medecines Evaluation Unit - Southmoor Road - M23 9QZ Manchester - UK
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 1535 Next DPI and Foster BDP/Formoterol 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 9 inclusion and 11 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. 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 AUC0-12h (time frame: Every week). 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.