AsthmaPhase 3NCT00862394
A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma
A Phase 3 study testing BDP/Formoterol Next DPI and Foster in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Germany.
Trial summary
To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of CHF 1535 via HFA-134a "extrafine" pMDI in terms of pulmonary function in moderate to severe symptomatic… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- BDP/Formoterol Next DPI and Foster
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 783 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2009to Jan 2010
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent
- Outpatients of both sexes, aged > 12 years
- Moderate to severe symptomatic asthma
- Forced expiratory volume in the first second (FEV1) > 40% and < 80% of the predicted normal values
- Reversibility test
- "Partly controlled" asthma (GINA revised 2006)
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- Patients free of long-acting beta2-agonists (LABAs) treatment
- Under inhaled corticosteroids (ICS) treatment
- A minimum inspiratory flow ≥ 40 L/min 10.
- Non-smokers or ex smokers
- Asthma Control Questionnaire ACQ score ≥ 1.5
Who cannot join
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, UNLESS they are menopausal or have 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
- Occurrence of asthma exacerbations or respiratory tract infections in the 6 weeks preceding the screening visit
- Diagnosis COPD
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- History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency
- Diagnosis of restrictive lung disease
- Patients treated with oral or parenteral corticosteroids in the previous 2 months (3 months for parenteral depot corticosteroids)
- Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids
- Allergy to any component of the study treatments
- Any change in the dose, schedule, formulation or product of an inhaled corticosteroid in the 4 weeks prior to screening visit
- Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality ;
- Patients with abnormal QTc
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 12-week, Multinational, Randomised, Double Blind, Double Dummy, 4-arm Parallel-group Study Comparing the Efficacy and Safety of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation, Via HFA Pressurised Inhalation Solution, in Moderate to Severe Symptomatic Asthmatic Patients Aged ≥ 12 Years Under Treatment With Inhaled Corticosteroids
To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of CHF 1535 via HFA-134a "extrafine" pMDI in terms of pulmonary function in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids
- Conditions
- Asthma
- Being tested
- BDP/Formoterol Next DPI, Foster
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BDP/Formoterol Next DPIDrug
BDP/Formoterol Next DPI 100/6 µg (daily dose : 200/12 µg)
FosterDrug
BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 200/12 µg)
BDP/Formoterol Next DPIDrug
BDP/Formoterol 100/6 µg (daily dose : 400/24 µg)
FosterDrug
BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 400/24 µg)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CHF 1535 Next DPI : BDP/Formoterol : 200/12 µg Receives: Drug: BDP/Formoterol Next DPI |
| 2 | Active comparator | CHF 1535 HFA pMDI : BDP/Formoterol : 200/12 µg Receives: Drug: Foster |
| 3 | Experimental | CHF 1535 Next DPI : BDP/Formoterol : 400/24 µg Receives: Drug: BDP/Formoterol Next DPI |
| 4 | Active comparator | CHF 1535 HFA pMDI : BDP/Formoterol : 400/24 µg Receives: Drug: Foster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline measured at clinic to the end of treatment period in pre-dose morning FEV1 (L) measured at clinic
Measured: 3 month period
Secondary outcomes (8)
Pre-dose FEV1
Measured: every month
Post-dose FEV1 AUC 0-8 h
Measured: 3 month period
FVC and FEF 25-75%
Measured: every month
PEF
Measured: every day
Morning and evening asthma clinical symptoms scores
Measured: every day
Moderate and severe exacerbations
Measured: every month
Rescue medication
Measured: every day
Sputum
Measured: 3 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2009
- Study completionJan 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 783 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
- NCT00862394
- Sponsor's protocol ID
- CCD-0705-PR-0027
- Status last verified
- Apr 2018
- First submitted
- 13 Mar 2009
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Multinational, Randomised, Double Blind, Double Dummy, 4-arm Parallel-group Study Comparing the Efficacy and Safety of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation, Via HFA Pressurised Inhalation Solution, in Moderate to Severe Symptomatic Asthmatic Patients Aged ≥ 12 Years Under Treatment With Inhaled Corticosteroids
- ClinicalTrials.gov ID
- NCT00862394
- Acronym / sponsor ID
- CCD-0705-PR-0027
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 783 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 16 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.
To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of CHF 1535 via HFA-134a "extrafine" pMDI in terms of pulmonary function in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BDP/Formoterol Next DPICHF 1535 Next DPI : BDP/Formoterol : 200/12 µg |
| 2 | Active comparator | Drug: FosterCHF 1535 HFA pMDI : BDP/Formoterol : 200/12 µg |
| 3 | Experimental | Drug: BDP/Formoterol Next DPICHF 1535 Next DPI : BDP/Formoterol : 400/24 µg |
| 4 | Active comparator | Drug: FosterCHF 1535 HFA pMDI : BDP/Formoterol : 400/24 µg |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent
- Outpatients of both sexes, aged > 12 years
- Moderate to severe symptomatic asthma
- Forced expiratory volume in the first second (FEV1) > 40% and < 80% of the predicted normal values
- Reversibility test
Key exclusion criteria (14 listed)
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, UNLESS they are menopausal or have 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
- Occurrence of asthma exacerbations or respiratory tract infections in the 6 weeks preceding the screening visit
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 |
|---|---|---|
| BDP/Formoterol Next DPIBDP/Formoterol Next DPI 100/6 µg (daily dose : 200/12 µg) | Drug | 1 |
| FosterBDP/Formoterol HFA pMDI 100/6 µg (daily dose : 200/12 µg) | Drug | 2 |
| BDP/Formoterol Next DPIBDP/Formoterol 100/6 µg (daily dose : 400/24 µg) | Drug | 3 |
| FosterBDP/Formoterol HFA pMDI 100/6 µg (daily dose : 400/24 µg) | Drug | 4 |
Primary outcome
Change from baseline measured at clinic to the end of treatment period in pre-dose morning FEV1 (L) measured at clinic
Time frame: 3 month period
8 secondary outcomes
Pre-dose FEV1
Time frame: every month
Post-dose FEV1 AUC 0-8 h
Time frame: 3 month period
FVC and FEF 25-75%
Time frame: every month
PEF
Time frame: every day
Morning and evening asthma clinical symptoms scores
Time frame: every day
Moderate and severe exacerbations
Time frame: every month
Rescue medication
Time frame: every day
Sputum
Time frame: 3 month period
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 13 Apr 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BDP/Formoterol Next DPI and Foster in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Germany.
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 11 inclusion and 14 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 13 Apr 2018. 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 from baseline measured at clinic to the end of treatment period in pre-dose morning FEV1 (L) measured at clinic (time frame: 3 month period). 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 13 Apr 2018.