AsthmaPhase 3NCT00476268
Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma
A Phase 3 study testing beclomethasone/formoterol (100/6µg) pMDI, Beclometasone dipropionate 250 µg/unit dose pMDI and Formoterol powder 12 µg/unit dose in people with Asthma, run by Chiesi Farmaceutici S.p.A..
Trial summary
Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe 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?
- beclomethasone/formoterol (100/6µg) pMDI, Beclometasone dipropionate 250 µg/unit dose pMDI and Formoterol powder 12 µg/unit dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 824 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Jan 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 moderate to severe persistent asthma (according to GINA 2002 guidelines)
- FEV1 > 40% and < 80% of predicted normal post-bronchodilator (and at least 0.7 L absolute value)
- Patients already treated for at least 2 months with an association of inhaled corticosteroids plus LABA at doses of:
- 750 - 1000 µg beclomethasone dipropionate or equivalent (ICSs) 24 µg formoterol or 100 µg salmeterol (LABAs)
- Or patients naïve of LABA already treated for at least 2 months with inhaled corticosteroids (doses as above) associated with a daily use of SABA and/or with clinical symptoms > 3 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.
- Clinically significant or unstable concomitant diseases, including clinically significant laboratory abnormalities.
- Patients with an abnormal QTc interval value in the ECG test, defined as > 450 msec in males or > 470 msec in females.
- Evidence of asthma worsening during the week preceding randomisation (e.g. PEF variability > 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 24-week Phase III Study to Evaluate the Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients With Moderate to Severe Persistent Asthma
Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.
Read the detailed description
The purpose of this study is to evaluate the efficacy and tolerability of beclometasone/formoterol single inhaler in a twice daily regimen in patients with moderate to severe persistent asthma. Patients are randomised to receive either beclometasone/formoterol single inhaler (total daily dose: BDP/FF 400/24 mcg) or beclometasone CFC + formoterol DPI (total daily dose: BDP 1000 mcg + FF 24 mcg) or beclometasone CFC (total daily dose: BDP 1000 mcg) during 24 weeks of treatment.
- Conditions
- Asthma
- Being tested
- beclomethasone/formoterol (100/6µg) pMDI, Beclometasone dipropionate 250 µg/unit dose pMDI, Formoterol powder 12 µg/unit dose
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beclomethasone/formoterol (100/6µg) pMDIDrug
Two puffs b.i.d
Beclometasone dipropionate 250 µg/unit dose pMDIDrug
Also called BecotideTM
2 inhalations bid
Formoterol powder 12 µg/unit doseDrug
Also called Foradil™
2 inhalations bid
| Study group | Role | What they receive |
|---|---|---|
| beclometasone /formoterol | Experimental | beclomethasone dipropionate 100 µg plus formoterol 6 µg pMDI Receives: Drug: beclomethasone/formoterol (100/6µg) pMDI |
| Beclomethasone | Active comparator | Beclomethasone dipropionate (BecotideTM) 250 µg/unit dose pMDI aerosol via CFC propellant. Receives: Drug: Beclometasone dipropionate 250 µg/unit dose pMDI |
| Formoterol powder 12 µg/unit dose | Active comparator | Formoterol powder 12 µg/unit dose (Foradil™) Receives: Drug: Formoterol powder 12 µg/unit dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-dose morning PEF
Measured: End of treatment
Secondary outcomes (7)
Pre-dose FEV1
Measured: At clinic visits
Other spirometric parameters
Measured: At clinic visits
Morning and evening asthma clinical symptom scores
Measured: End of treatment
Percentage of night and/or days free of clinical symptoms
Measured: End of treatment
Use of rescue short-acting b2-agonists
Measured: End of treatment
Asthma exacerbations
Measured: end of treatment
safety and tolerability
Measured: end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startFeb 2004
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 824 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francoise Bonnet-Gonod, Study director, Chiesi Farmaceutici
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476268
- Sponsor's protocol ID
- DM/PR/033011/003/03
- Status last verified
- Oct 2024
- First submitted
- 18 May 2007
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Huchon G, Magnussen H, Chuchalin A, Dymek L, Gonod FB, Bousquet J. Lung function and asthma control with beclomethasone and formoterol in a single inhaler. Respir Med. 2009 Jan;103(1):41-9. doi: 10.1016/j.rmed.2008.09.002. Epub 2008 Nov 1.
PubMed 18977646
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week Phase III Study to Evaluate the Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients With Moderate to Severe Persistent Asthma
- ClinicalTrials.gov ID
- NCT00476268
- Acronym / sponsor ID
- DM/PR/033011/003/03
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 824 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 21 May 2007 (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 beclometasone/formoterol in patients with moderate to severe persistent asthma.
Detailed description
The purpose of this study is to evaluate the efficacy and tolerability of beclometasone/formoterol single inhaler in a twice daily regimen in patients with moderate to severe persistent asthma. Patients are randomised to receive either beclometasone/formoterol single inhaler (total daily dose: BDP/FF 400/24 mcg) or beclometasone CFC + formoterol DPI (total daily dose: BDP 1000 mcg + FF 24 mcg) or beclometasone CFC (total daily dose: BDP 1000 mcg) during 24 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| beclometasone /formoterol | Experimental | Drug: beclomethasone/formoterol (100/6µg) pMDIbeclomethasone dipropionate 100 µg plus formoterol 6 µg pMDI |
| Beclomethasone | Active comparator | Drug: Beclometasone dipropionate 250 µg/unit dose pMDIBeclomethasone dipropionate (BecotideTM) 250 µg/unit dose pMDI aerosol via CFC propellant. |
| Formoterol powder 12 µg/unit dose | Active comparator | Drug: Formoterol powder 12 µg/unit doseFormoterol powder 12 µg/unit dose (Foradil™) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of moderate to severe persistent asthma (according to GINA 2002 guidelines)
- FEV1 > 40% and < 80% of predicted normal post-bronchodilator (and at least 0.7 L absolute value)
- Patients already treated for at least 2 months with an association of inhaled corticosteroids plus LABA at doses of:
- 750 - 1000 µg beclomethasone dipropionate or equivalent (ICSs) 24 µg formoterol or 100 µg salmeterol (LABAs)
- Or patients naïve of LABA already treated for at least 2 months with inhaled corticosteroids (doses as above) associated with a daily use of SABA and/or with clinical symptoms > 3 times in the week prior to inclusion
Key exclusion criteria (7 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.
- Clinically 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 |
|---|---|---|
| beclomethasone/formoterol (100/6µg) pMDITwo puffs b.i.d | Drug | beclometasone /formoterol |
| Beclometasone dipropionate 250 µg/unit dose pMDIAlso: BecotideTM2 inhalations bid | Drug | Beclomethasone |
| Formoterol powder 12 µg/unit doseAlso: Foradil™2 inhalations bid | Drug | Formoterol powder 12 µg/unit dose |
Primary outcome
Pre-dose morning PEF
Time frame: End of treatment
7 secondary outcomes
Pre-dose FEV1
Time frame: At clinic visits
Other spirometric parameters
Time frame: At clinic visits
Morning and evening asthma clinical symptom scores
Time frame: End of treatment
Percentage of night and/or days free of clinical symptoms
Time frame: End of treatment
Use of rescue short-acting b2-agonists
Time frame: End of treatment
Asthma exacerbations
Time frame: end of treatment
safety and tolerability
Time frame: end of treatment
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 31 Oct 2024.
- Results publication: PubMed 18977646Huchon G, Magnussen H, Chuchalin A, Dymek L, Gonod FB, Bousquet J. Lung function and asthma control with beclomethasone and formoterol in a single inhaler. Respir Med. 2009 Jan;103(1):41-9. doi: 10.1016/j.rmed.2008.09.002. Epub 2008 Nov 1.
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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.
Francoise Bonnet-Gonod study director
Chiesi Farmaceutici
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing beclomethasone/formoterol (100/6µg) pMDI, Beclometasone dipropionate 250 µg/unit dose pMDI and Formoterol powder 12 µg/unit dose 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 6 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 31 Oct 2024. 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: End of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00476268, which also lists 1 linked publication.
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 31 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.