AsthmaPhase 3NCT00862264
Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler in Patients With Mild to Moderate Persistent Asthma
A Phase 3 study testing Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI in people with Asthma, run by Chiesi Farmaceutici S.p.A..
Trial summary
Efficacy and tolerability of the fixed combination Beclomethasone Dipropionate /Formoterol in patients with mild to moderate persistent asthma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Sep 2005
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of mild to moderate persistent asthma (according to GINA 2003 guidelines)
- FEV1 > or = 60% and < or = 85% of predicted normal values
- Patients free of LABA at least for one month before screening and already treated for at least two months with ICS and experiencing (i)a daily use of SABAs between 1 and 4 puffs, (ii) and/or clinical symptoms three times in the week prior to inclusion
- A documented positive response to the reversibility test
Who cannot join
- Pregnant or lactating females or women of childbearing potential without any efficient contraception
- Heavy smokers defined as smoking for > 10 pack years
- Evidence of asthma exacerbation causing an hospitalisation or requiring treatment with oral/parenteral corticosteroids or evidence of symptomatic airways infection in the 4 weeks prior to inclusion (3 months for slow-release corticosteroids)
- Seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer
- Clinical significant or unstable concomitant diseases, including clinically significant laboratory abnormalities
- Evidence of asthma worsening during the week preceding randomisation (e.g PEF variability > or = 30% during 2 consecutive days, SABA use > 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days
About this study
Official title: A 12-week Phase III Study to Evaluate the Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients With Mild to Moderate Persistent Asthma
Efficacy and tolerability of the fixed combination Beclomethasone Dipropionate /Formoterol in patients with mild to moderate persistent asthma.
Read the detailed description
The purpose of this study is to evaluate the efficacy and tolerability of Beclomethasone Dipropionate/Formoterol single inhaler in a twice daily regimen in patients with mild to moderate persistent asthma. Patients are randomised to receive either Beclomethasone Dipropionate/ formoterol single inhaler (total daily dose : BDP/FF 400/24 µg) or Beclomethasone CFC (total daily dose : BDP 1000 µg) during 12 weeks of treatment.
- Conditions
- Asthma
- Being tested
- Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDIDrug
Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
| Study group | Role | What they receive |
|---|---|---|
| CHF 1535 pMDI | Experimental | CHF 1535 HFA pMDI aerosol (100 µg/unit dose of beclomethasone dipropionate plus 6 µg of formoterol/unit dose Receives: Drug: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI |
| BDP pMDI | Active comparator | Beclomethasone dipropionate-CFC pMDI, 250 µg/unit dose Receives: Drug: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-dose morning PEF
Measured: At the end of treatment after 3 month of treatment
Secondary outcomes (6)
Pre-dose FEV1 - Other spirometric parameters -
Measured: Every 6 weeks
Percentage of night and/or days free of clinical symptoms
Measured: End of treatment after 3 month of treatment
Morning and evening asthma clinical symptom scores
Measured: End of treatment after 3 month of treatment
Use of rescue short-acting b2-agonists
Measured: End of treatment after 3 month of treatment
Asthma exacerbations
Measured: Every 6 weeks
Safety and Tolerability
Measured: Every 6 weeks
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 startAug 2004
- Study completionSep 2005
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
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Françoise Bonnet Gonod, Study director, Chiesi Farmaceutici
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862264
- Sponsor's protocol ID
- RA/PR/033011/005/04
- Other IDs
- 2004-000718-37, 2004
- Status last verified
- Mar 2017
- First submitted
- 25 Feb 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 12-week Phase III Study to Evaluate the Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients With Mild to Moderate Persistent Asthma
- ClinicalTrials.gov ID
- NCT00862264
- Acronym / sponsor ID
- RA/PR/033011/005/04
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Aug 2004
- Study completion
- Sep 2005 (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.
Efficacy and tolerability of the fixed combination Beclomethasone Dipropionate /Formoterol in patients with mild to moderate persistent asthma.
Detailed description
The purpose of this study is to evaluate the efficacy and tolerability of Beclomethasone Dipropionate/Formoterol single inhaler in a twice daily regimen in patients with mild to moderate persistent asthma. Patients are randomised to receive either Beclomethasone Dipropionate/ formoterol single inhaler (total daily dose : BDP/FF 400/24 µg) or Beclomethasone CFC (total daily dose : BDP 1000 µg) during 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHF 1535 pMDI | Experimental | Drug: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDICHF 1535 HFA pMDI aerosol (100 µg/unit dose of beclomethasone dipropionate plus 6 µg of formoterol/unit dose |
| BDP pMDI | Active comparator | Drug: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDIBeclomethasone dipropionate-CFC pMDI, 250 µg/unit dose |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of mild to moderate persistent asthma (according to GINA 2003 guidelines)
- FEV1 > or = 60% and < or = 85% of predicted normal values
- Patients free of LABA at least for one month before screening and already treated for at least two months with ICS and experiencing (i)a daily use of SABAs between 1 and 4 puffs, (ii) and/or clinical symptoms three times in the week prior to inclusion
- A documented positive response to the reversibility test
Key exclusion criteria (6 listed)
- Pregnant or lactating females or women of childbearing potential without any efficient contraception
- Heavy smokers defined as smoking for > 10 pack years
- Evidence of asthma exacerbation causing an hospitalisation or requiring treatment with oral/parenteral corticosteroids or evidence of symptomatic airways infection in the 4 weeks prior to inclusion (3 months for slow-release corticosteroids)
- Seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer
- Clinical significant or unstable concomitant diseases, including clinically significant laboratory abnormalities
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 |
|---|---|---|
| Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDIFixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI | Drug | BDP pMDI, CHF 1535 pMDI |
Primary outcome
Pre-dose morning PEF
Time frame: At the end of treatment after 3 month of treatment
6 secondary outcomes
Pre-dose FEV1 - Other spirometric parameters -
Time frame: Every 6 weeks
Percentage of night and/or days free of clinical symptoms
Time frame: End of treatment after 3 month of treatment
Morning and evening asthma clinical symptom scores
Time frame: End of treatment after 3 month of treatment
Use of rescue short-acting b2-agonists
Time frame: End of treatment after 3 month of treatment
Asthma exacerbations
Time frame: Every 6 weeks
Safety and Tolerability
Time frame: Every 6 weeks
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.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Françoise Bonnet Gonod study director
Chiesi Farmaceutici
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI in people with Asthma, run by Chiesi Farmaceutici S.p.A..
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 4 inclusion and 6 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.
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?
Pre-dose morning PEF (time frame: At the end of treatment after 3 month 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.