AsthmaPhase 3NELSONNCT01570478
A Study in Patients With Asthma
A Phase 3 study testing Foster® NEXThaler® 100/6 µg/unit dose and Seretide® Accuhaler® 250/50 µg/actuation in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Italy.
Trial summary
The purpose of the present study is to demonstrate the higher efficacy of Foster® NEXThaler® 100/6 extra fine (two inhalations b.i.d.) versus Seretide® Accuhaler® 250/50 (one inhalation b.i.d.), in terms of pulmonary function (change from baseline to the end of treatment in post-dose peripheral airway resistance) in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Foster® NEXThaler® 100/6 µg/unit dose and Seretide® Accuhaler® 250/50 µg/actuation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2012to Feb 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatients aged ≥ 18, who have signed an Informed Consent form prior to initiation of any study-related procedure.
- Clinical diagnosis of asthma for a minimum of 12 months prior to screening confirmed by a chest physician according to international guidelines (GINA). The evidence of asthma must be confirmed through a documented (in the last three years) positive response to the reversibility test, defined as ΔFEV1 ≥ 12% and ≥ 200 mL over baseline, within 30 minutes after administration of 400 μg of salbutamol pMDI or through a documented (in the last three years) positive response to methacholine challenge test (PC20 < 8 mg/mL or PD20 < 1 mg).
- Baseline FEV1 > 80% of the predicted normal value after appropriate washout from bronchodilators (to be checked at screening and at randomisation visits).
- Asthma Control Test score ≥ 20 and < 25 (to be checked at screening and at randomisation visits).
- Impaired small airways function defined as baseline peripheral airway resistance [R(5Hz)-R(20Hz)] ≥ 0.07 kPa/L/s (to be checked at screening and at randomisation visits).
- Patients on previous regular treatment with Seretide® Accuhaler® (fluticasone propionate 250 μg plus salmeterol xinafoate 50 μg per actuation, daily dose of fluticasone 500 μg plus salmeterol 100 μg) at a stable dose for at least 2 months prior to inclusion.
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- A cooperative attitude and ability to be trained to the proper use of DPI.
- Main Exclusion Criteria:
- Patients with a diagnosis of COPD according to GOLD guidelines.
- Current smokers with a smoking history of > 10 pack/year.
- Patients who have a clinical or functional uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that might, in the judgment of the investigator, represent for the patients an undue risk or that could compromise the results or interpretation of the study.
- History or current evidence of uncontrolled heart failure, clinically relevant coronary artery disease, recent myocardial infarction, severe hypertension, uncontrolled cardiac arrhythmias.
- Patients treated with LABA or ICS/LABA fixed combination in the 24 hours before the screening visit.
- Severe asthma exacerbation leading to intake of systemic corticosteroids (> 10 days) in the month before the screening visit.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dipartimento Cardio-Polmonare - Azienda Ospedaliero-Universitaria - Padiglione Rasori
Parma, 43100
About this study
Official title: A 12-week, Multicenter, Randomized, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of Foster® NEXThaler® (Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg/Actuation), 2 Inhalations b.i.d., Versus Seretide® Accuhaler® (Fluticasone 250 µg Plus Salmeterol 50 µg/Actuation), 1 Inhalation b.i.d., on Small Airway Derived Parameters in Patients With Asthma
The purpose of the present study is to demonstrate the higher efficacy of Foster® NEXThaler® 100/6 extra fine (two inhalations b.i.d.) versus Seretide® Accuhaler® 250/50 (one inhalation b.i.d.), in terms of pulmonary function (change from baseline to the end of treatment in post-dose peripheral airway resistance) in patients with asthma.
Read the detailed description
Asthma is a chronic inflammatory disease characterised by variable airflow obstruction and bronchial hyper responsiveness. Asthma affects both the large and the small airways and there is a growing body of evidence that small airways impairment is an important contributor to the pathogenesis and clinical expression of the disease.
- Conditions
- Asthma
- Being tested
- Foster® NEXThaler® 100/6 µg/unit dose, Seretide® Accuhaler® 250/50 µg/actuation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foster® NEXThaler® 100/6 µg/unit doseDrug
Foster® NEXThaler® (beclomethasone dipropionate 100 µg plus formoterol 6 µg per actuation), 2 inhalations b.i.d. (daily dose of BDP 400 µg plus FF 24 µg)
Seretide® Accuhaler® 250/50 µg/actuationDrug
Seretide® Accuhaler® (fluticasone propionate 250 μg plus salmeterol xinafoate 50 μg per actuation), 1 inhalation b.i.d. (daily dose of fluticasone 500 μg plus salmeterol 100 μg)
| Study group | Role | What they receive |
|---|---|---|
| Foster® NEXThaler® | Experimental | Foster® NEXThaler® (beclomethasone dipropionate 100 µg plus formoterol 6 µg per actuation), 2 inhalations b.i.d. (daily dose of BDP 400 µg plus FF 24 µg) Receives: Drug: Foster® NEXThaler® 100/6 µg/unit dose |
| Seretide® Accuhaler® | Active comparator | Seretide® Accuhaler® (fluticasone propionate 250 μg plus salmeterol xinafoate 50 μg per actuation), 1 inhalation b.i.d. (daily dose of fluticasone 500 μg plus salmeterol 100 μg) Receives: Drug: Seretide® Accuhaler® 250/50 µg/actuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to end of treatment in post-dose peripheral airway resistance [R(5Hz)-R(20Hz)].
Measured: Baseline and 3 months
Secondary outcomes (3)
Changes from baseline at each clinic visit in pre and post-dose Impulse Oscillometry (IOS)/plethysmographic/spirometric parameters
Measured: After 4, 8, 12 weeks of treatment
Asthma exacerbations (severe)
Measured: Up to 12 weeks of treatment
Clinical measures of asthma control
Measured: Up to 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionFeb 2014
- Study completionFeb 2014
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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alfredo Chetta, MD, Principal investigator, Dept. of Cardiology and Pulmonary Medicine - Pama, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570478
- Sponsor's protocol ID
- MC/PR/15009/001/11
- Other IDs
- 2011-003449-17
- Acronym
- NELSON
- Status last verified
- Mar 2017
- First submitted
- 28 Mar 2012
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Oba 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 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Multicenter, Randomized, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of Foster® NEXThaler® (Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg/Actuation), 2 Inhalations b.i.d., Versus Seretide® Accuhaler® (Fluticasone 250 µg Plus Salmeterol 50 µg/Actuation), 1 Inhalation b.i.d., on Small Airway Derived Parameters in Patients With Asthma
- ClinicalTrials.gov ID
- NCT01570478
- Acronym / sponsor ID
- NELSON / MC/PR/15009/001/11
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 4 Apr 2012 (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.
The purpose of the present study is to demonstrate the higher efficacy of Foster® NEXThaler® 100/6 extra fine (two inhalations b.i.d.) versus Seretide® Accuhaler® 250/50 (one inhalation b.i.d.), in terms of pulmonary function (change from baseline to the end of treatment in post-dose peripheral airway resistance) in patients with asthma.
Detailed description
Asthma is a chronic inflammatory disease characterised by variable airflow obstruction and bronchial hyper responsiveness. Asthma affects both the large and the small airways and there is a growing body of evidence that small airways impairment is an important contributor to the pathogenesis and clinical expression of the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foster® NEXThaler® | Experimental | Drug: Foster® NEXThaler® 100/6 µg/unit doseFoster® NEXThaler® (beclomethasone dipropionate 100 µg plus formoterol 6 µg per actuation), 2 inhalations b.i.d. (daily dose of BDP 400 µg plus FF 24 µg) |
| Seretide® Accuhaler® | Active comparator | Drug: Seretide® Accuhaler® 250/50 µg/actuationSeretide® Accuhaler® (fluticasone propionate 250 μg plus salmeterol xinafoate 50 μg per actuation), 1 inhalation b.i.d. (daily dose of fluticasone 500 μg plus salmeterol 100 μg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female outpatients aged ≥ 18, who have signed an Informed Consent form prior to initiation of any study-related procedure.
- Clinical diagnosis of asthma for a minimum of 12 months prior to screening confirmed by a chest physician according to international guidelines (GINA). The evidence of asthma must be confirmed through a documented (in the last three years) positive response to the reversibility test, defined as ΔFEV1 ≥ 12% and ≥ 200 mL over baseline, within 30 minutes after administration of 400 μg of salbutamol pMDI or through a documented (in the last three years) positive response to methacholine challenge test (PC20 < 8 mg/mL or PD20 < 1 mg).
- Baseline FEV1 > 80% of the predicted normal value after appropriate washout from bronchodilators (to be checked at screening and at randomisation visits).
- Asthma Control Test score ≥ 20 and < 25 (to be checked at screening and at randomisation visits).
- Impaired small airways function defined as baseline peripheral airway resistance [R(5Hz)-R(20Hz)] ≥ 0.07 kPa/L/s (to be checked at screening and at randomisation visits).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Foster® NEXThaler® 100/6 µg/unit doseFoster® NEXThaler® (beclomethasone dipropionate 100 µg plus formoterol 6 µg per actuation), 2 inhalations b.i.d. (daily dose of BDP 400 µg plus FF 24 µg) | Drug | Foster® NEXThaler® |
| Seretide® Accuhaler® 250/50 µg/actuationSeretide® Accuhaler® (fluticasone propionate 250 μg plus salmeterol xinafoate 50 μg per actuation), 1 inhalation b.i.d. (daily dose of fluticasone 500 μg plus salmeterol 100 μg) | Drug | Seretide® Accuhaler® |
Primary outcome
Change from baseline to end of treatment in post-dose peripheral airway resistance [R(5Hz)-R(20Hz)].
Time frame: Baseline and 3 months
3 secondary outcomes
Changes from baseline at each clinic visit in pre and post-dose Impulse Oscillometry (IOS)/plethysmographic/spirometric parameters
Time frame: After 4, 8, 12 weeks of treatment
Asthma exacerbations (severe)
Time frame: Up to 12 weeks of treatment
Clinical measures of asthma control
Time frame: Up to 12 weeks 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 29 Mar 2017.
- 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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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.
Alfredo Chetta, MD principal investigator
Dept. of Cardiology and Pulmonary Medicine - Pama, Italy
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 Foster® NEXThaler® 100/6 µg/unit dose and Seretide® Accuhaler® 250/50 µg/actuation in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Italy.
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 14 inclusion and 0 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 29 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 Italy. 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 to end of treatment in post-dose peripheral airway resistance [R(5Hz)-R(20Hz)]. (time frame: Baseline and 3 months). 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 NCT01570478, 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 29 Mar 2017.