Asthmatic PatientsPhase 4FACTONCT00901368
FACTO Study (Foster® As Complete Treatment Option)
A Phase 4 study testing FOSTER and Seretide in people with Asthmatic Patients, run by Chiesi Farmaceutici S.p.A. at 4 sites in 4 countries.
Trial summary
Double blind, multinational, multicentre, randomised, 2 arm parallel group study Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthmatic Patients
- What is being tested?
- FOSTER and Seretide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 431 participants
- Where
- 4 sitesin 4 countries
- Study dates
- May 2009to Dec 2010
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asthmatic patients will be enrolled at Visit 1 into the run-in period if they meet all of the following criteria:
- Written informed consent obtained
- Adult male and female (≥18 and ≤65 years)
- Clinical diagnosis of controlled asthma according to Global Strategy for Asthma Management and Prevention (GINA) revised version 2007 in the previous week before study entry:
- no daytime symptoms (twice or less/week)
- no limitations of activities
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- no nocturnal symptoms/awakenings
- no need for reliever/rescue medications (twice or less/week)
- lung function (FEV1) > 80% predicted or personal best (if known)
- Patients treated with fluticasone 500 µg + salmeterol 100 µg daily for ≥ 4 weeks
- A co-operative attitude and ability to correctly use the device and to complete the diary cards.
Who cannot join
- Patients will not be enrolled at visit 1 into the run-in period if they meet any of the following criteria:
- Inability to carry out pulmonary function testing;
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the National Heart Lung and Blood Institute/World Health Organisation (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines;
- History of near fatal asthma;
- Evidence of severe asthma exacerbation or symptomatic infection of the lower airways in the previous six months;
- Three or more courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months;
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- Patients treated with long-acting β2-agonists (LABAs) other than salmeterol, anticholinergics, and leukotriene antagonists during the previous 4 weeks;
- Current smokers or recent (less than one year) ex-smokers defined as smoking at least 15 packs/year;
- Clinically significant or unstable concurrent disease : e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; significant other pulmonary disease; cardiovascular disease; gastrointestinal disease; neurological disease; haematological disease, autoimmune disorders, that may interfere with patient's safety, compliance, or study evaluations, according to the investigator's opinion;
- Patients with a serum potassium value ≤ 3.5 mEq/L
- Patients with QTc interval (Bazett's formula) higher than 450 msec at screening visit 1;
- Cancer or any chronic diseases with prognosis < 2 years;
- Female subjects: pregnant or with active desire to be pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential (i.e. contraceptive methods other than oral contraceptives, IUD, tubal ligature). A pregnancy test in urine is to be carried out in women of a fertile age at screening
- Significant alcohol consumption or drug abuse;
- Patients treated with beta-blockers as regular use;
- Patients treated with monoamine oxidase inhibitor, tricyclic antidepressants and Selective Serotonin Re-uptake Inhibitors (SSRIs), unless already taken at stable doses at the screening visit
- Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients;
- Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
- Patients who received any investigational new drug within the last 12 weeks;
- Patients with asthma exacerbations during the run-in period will also be excluded from the study.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Germany1 site
Allergologie imUmkreis der Praxis Pneumologie
Gelsenkirchen, North Rhine-Westphalia, 45879
About this study
Official title: A PHASE 4, MULTINATIONAL, MULTICENTRE, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, PARALLEL GROUP, CONTROLLED CLINICAL STUDY OF FIXED COMBINATION BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg pMDI WITH HFA-134A PROPELLANT (CHF1535, FOSTER®) VERSUS FLUTICASONE 250 µg PLUS SALMETEROL 50 µg DPI (SERETIDE® DISKUS®) AS MAINTENANCE TREATMENT IN CONTROLLED ASTHMATIC PATIENTS.
Double blind, multinational, multicentre, randomised, 2 arm parallel group study
Read the detailed description
Aim of the present investigation is to demonstrate the clinical equivalence between fluticasone plus salmeterol 500/100 µg daily and an equipotent dose of CHF1535 in maintaining the same asthma control in patients adequately controlled with fluticasone plus salmeterol at the above mentioned daily dose.
- Conditions
- Asthmatic Patients
- Being tested
- FOSTER, Seretide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOSTERDrug
CHF1535 (beclometasone dipropionate 100 µg plus formoterol 6 µg) pMDI aerosol via HFA-134a propellant 2 inhalations b.i.d. (daily dose 400 µg + 24µg)
SeretideDrug
Fluticasone 250 µg + salmeterol 50 µg DPI (Seretide® Diskus®) 1 inhalation b.i.d. (daily dose 500+100 µg)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CHF1535 (beclometasone dipropionate plus formoterol, 400/24 µg daily) Receives: Drug: FOSTER |
| 2 | Active comparator | Seretide® Diskus® (fluticasone plus salmeterol, 500/100 µg /daily) Receives: Drug: Seretide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-dose morning FEV1 measured at clinic visit 5
Measured: 12-week treatment
Secondary outcomes (8)
FEV1 area under the curve (AUC) in the first hour post-dose measured at clinics at visit 2 and visit 5
Measured: 12-week treatment
Pulmonary function tests measured at clinics (FEV1,PEF, FVC, FEF25-75%)
Measured: 12-week treatment
ACQ score at baseline and at the end of treatment period
Measured: 12-week treatment
Use of rescue medication
Measured: 12-week treatment
Number of patients with controlled or partly controlled asthma at clinic visits according to GINA guidelines revised version 2007
Measured: 12-week treatment
Days without asthma symptoms (%), days without use of rescue medication (%) and daily asthma symptoms' score from diary cards
Measured: 12-week treatment
Pharmacoeconomic analyses assessing differences in direct medical costs (healthcare perspective) and in both direct healthcare and indirect costs (societal perspective).
Measured: 12-week treatment
Adverse events and adverse drug reactions,ECG ,Vital signs, Haematology/blood chemistry tests, OUCC ratio in a in a subgroup of 15% of patients
Measured: 12-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Asthmatic PatientsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil Barnes, MD, Principal investigator, Department ofRespiratory Medicine, London Chest Hospital, Barts& The London NHS Trust,Bonner Road, E2 9JX, London (UK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901368
- Sponsor's protocol ID
- CCD-0806-PR-0032
- Other IDs
- 2008-003740-11, 2008
- Acronym
- FACTO
- Status last verified
- Mar 2017
- First submitted
- 12 May 2009
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Barnes N, van Noord JA, Brindicci C, Lindemann L, Varoli G, Perpina M, Guastalla D, Casula D, Patel S, Chanez P; FACTO (Foster(R) As Complete Treatment Option) Study Group. Stepping-across controlled asthmatic patients to extrafine beclometasone/formoterol combination. Pulm Pharmacol Ther. 2013 Oct;26(5):555-61. doi: 10.1016/j.pupt.2013.01.011. Epub 2013 Mar 22.
PubMed 23524015Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
PubMed 36472162
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 4, MULTINATIONAL, MULTICENTRE, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, PARALLEL GROUP, CONTROLLED CLINICAL STUDY OF FIXED COMBINATION BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg pMDI WITH HFA-134A PROPELLANT (CHF1535, FOSTER®) VERSUS FLUTICASONE 250 µg PLUS SALMETEROL 50 µg DPI (SERETIDE® DISKUS®) AS MAINTENANCE TREATMENT IN CONTROLLED ASTHMATIC PATIENTS.
- ClinicalTrials.gov ID
- NCT00901368
- Acronym / sponsor ID
- FACTO / CCD-0806-PR-0032
- Conditions
- Asthmatic Patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 May 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.
Double blind, multinational, multicentre, randomised, 2 arm parallel group study
Detailed description
Aim of the present investigation is to demonstrate the clinical equivalence between fluticasone plus salmeterol 500/100 µg daily and an equipotent dose of CHF1535 in maintaining the same asthma control in patients adequately controlled with fluticasone plus salmeterol at the above mentioned daily dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: FOSTERCHF1535 (beclometasone dipropionate plus formoterol, 400/24 µg daily) |
| 2 | Active comparator | Drug: SeretideSeretide® Diskus® (fluticasone plus salmeterol, 500/100 µg /daily) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Asthmatic patients will be enrolled at Visit 1 into the run-in period if they meet all of the following criteria:
- Written informed consent obtained
- Adult male and female (≥18 and ≤65 years)
- Clinical diagnosis of controlled asthma according to Global Strategy for Asthma Management and Prevention (GINA) revised version 2007 in the previous week before study entry:
- Patients treated with fluticasone 500 µg + salmeterol 100 µg daily for ≥ 4 weeks
Key exclusion criteria (20 listed)
- Patients will not be enrolled at visit 1 into the run-in period if they meet any of the following criteria:
- Inability to carry out pulmonary function testing;
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the National Heart Lung and Blood Institute/World Health Organisation (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines;
- History of near fatal asthma;
- Evidence of severe asthma exacerbation or symptomatic infection of the lower airways in the previous six months;
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 |
|---|---|---|
| FOSTERCHF1535 (beclometasone dipropionate 100 µg plus formoterol 6 µg) pMDI aerosol via HFA-134a propellant 2 inhalations b.i.d. (daily dose 400 µg + 24µg) | Drug | 1 |
| SeretideFluticasone 250 µg + salmeterol 50 µg DPI (Seretide® Diskus®) 1 inhalation b.i.d. (daily dose 500+100 µg) | Drug | 2 |
Primary outcome
Pre-dose morning FEV1 measured at clinic visit 5
Time frame: 12-week treatment
8 secondary outcomes
FEV1 area under the curve (AUC) in the first hour post-dose measured at clinics at visit 2 and visit 5
Time frame: 12-week treatment
Pulmonary function tests measured at clinics (FEV1,PEF, FVC, FEF25-75%)
Time frame: 12-week treatment
ACQ score at baseline and at the end of treatment period
Time frame: 12-week treatment
Use of rescue medication
Time frame: 12-week treatment
Number of patients with controlled or partly controlled asthma at clinic visits according to GINA guidelines revised version 2007
Time frame: 12-week treatment
Days without asthma symptoms (%), days without use of rescue medication (%) and daily asthma symptoms' score from diary cards
Time frame: 12-week treatment
Pharmacoeconomic analyses assessing differences in direct medical costs (healthcare perspective) and in both direct healthcare and indirect costs (societal perspective).
Time frame: 12-week treatment
Adverse events and adverse drug reactions,ECG ,Vital signs, Haematology/blood chemistry tests, OUCC ratio in a in a subgroup of 15% of patients
Time frame: 12-week 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 30 Mar 2017.
- Results publication: PubMed 23524015Barnes N, van Noord JA, Brindicci C, Lindemann L, Varoli G, Perpina M, Guastalla D, Casula D, Patel S, Chanez P; FACTO (Foster(R) As Complete Treatment Option) Study Group. Stepping-across controlled asthmatic patients to extrafine beclometasone/formoterol combination. Pulm Pharmacol Ther. 2013 Oct;26(5):555-61. doi: 10.1016/j.pupt.2013.01.011. Epub 2013 Mar 22.
- Derived from this study: PubMed 36472162Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
- 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.
Neil Barnes, MD principal investigator
Department ofRespiratory Medicine, London Chest Hospital, Barts& The London NHS Trust,Bonner Road, E2 9JX, London (UK)
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FOSTER and Seretide in people with Asthmatic Patients, run by Chiesi Farmaceutici S.p.A. at 4 sites in 4 countries.
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 20 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 4 sites in France, Germany, Netherlands, Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 FEV1 measured at clinic visit 5 (time frame: 12-week 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 NCT00901368, which also lists 2 linked publications.
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; AzTrials last refreshed its copy on 30 Oct 2026.