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AsthmaPhase 3NeptuneNCT01345916

Efficacy of CHF1535 Via NEXT DPI Versus pMDI and BDP DPI100µg on PeakExpiratoryFlow in Asthmatic Patients

A Phase 3 study testing CHF 1535 100/6 NEXT DPI® 2 months, CHF 1535 100/6 pMDI 2 months and BDP DPI 2 months in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to demonstrate that CHF 1535 NEXT DPI® is non-inferior to the corresponding dose of CHF 1535 pMDI and superior to marketed beclomethasone DPI 100 µg in terms of average pre-dose morning Peak Expiratory Flow (PEF) in asthmatic adult patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
CHF 1535 100/6 NEXT DPI® 2 months, CHF 1535 100/6 pMDI 2 months and BDP DPI 2 months
Could I receive a placebo?
No, everyone receives an active treatment
How many people
932 participants
Where
1 sitePoland
Study dates
Mar 2011to Aug 2011
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 and female adults (≥18 years old).
  • Reversibility test defined as ΔFEV1 ≥ 12% and ≥ 200 mL .
  • FEV1 > 80% of the predicted values .
  • Asthma Control Questionnaire score < 1.25.
  • Asthmatic patients
  • Non- or ex-smokers

Who cannot join

  • History of near fatal asthma.
  • COPD patients
  • Asthma exacerbation within 1 month prior to the screening visit or asthma exacerbation during the run-in period.
  • Lower respiratory tract infection within 1 month prior Visit1 (V1).
  • History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.
  • Diagnosis of restrictive lung disease.
Show all 10Show fewer
  • Patients treated with oral or parenteral corticosteroids in the previous 2 months before V1
  • Intolerance or contra-indication to treatment with beta 2-agonists and/or inhaled corticosteroids or allergy to any component of the study treatments.
  • Significant medical history of and/or treatments
  • Active cancer or a history of cancer .

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • GSPZOZ Uniwersytecki Szpital Kliniczny

    Lodz, 90-153

Other trials in Poland

About this study

Official title: A Phase 3,8-week Clinical Trial to Test the Efficacy of CHF1535 Via NEXT DPI® Versus Same Dose of CHF1535 pMDI and Beclomethasone DPI 100µg on PEF in Adult Asthmatic Patients After 1 Month of Treatment With FOSTER®

The purpose of this study is to demonstrate that CHF 1535 NEXT DPI® is non-inferior to the corresponding dose of CHF 1535 pMDI and superior to marketed beclomethasone DPI 100 µg in terms of average pre-dose morning Peak Expiratory Flow (PEF) in asthmatic adult patients.

Read the detailed description

The primary objective is to demonstrate that CHF 1535 NEXT DPI® (beclomethasone dipropionate + formoterol fumarate 100/6 μg), 1 inhalation twice daily, is non-inferior to the corresponding dose of CHF 1535 pMDI in terms of pulmonary function test (change from baseline to the entire treatment period in average pre-dose morning PEF) in asthmatic adult patients ≥ 18 years under treatment with fixed dose combination of Foster® (beclomethasone dipropionate + formoterol fumarate 100 / 6 μg) 1 inhalation bid.

Conditions
Asthma
Being tested
CHF 1535 100/6 NEXT DPI® 2 months, CHF 1535 100/6 pMDI 2 months, BDP DPI 2 months
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHF 1535 100/6 NEXT DPI® 2 monthsDrug

    CHF 1535 100/6 NEXT DPI® 2 months

  • CHF 1535 100/6 pMDI 2 monthsDrug

    Also called Foster®

    CHF 1535 100/6 pMDI 2 months

  • BDP DPI 2 monthsDrug

    Also called Clenil® Pulvinal®

    BDP DPI 2 months

Study groups in NCT01345916
Study groupRoleWhat they receive
CHF 1535 100/6 NEXT Dry Powder Inhaler®ExperimentalCHF1535 100/6 NEXT DPI® 1 inhalation bis in day (b.i.d) (daily dose BDP 200/FF 12 µg)
Receives: Drug: CHF 1535 100/6 NEXT DPI® 2 months
CHF1535 100/6 pMDIActive comparatorCHF1535 100/6 pressurisedMeterDoseInhaler 1 inhalation b.i.d (total daily dose BDP 200/FF 12 µg)
Receives: Drug: CHF 1535 100/6 pMDI 2 months
beclomethasone dipropionate DPIActive comparatorbeclomethasone dipropionate 100 µg DPI, 1 inhalation b.i.d (total daily dose BDP 200 µg)
Receives: Drug: BDP DPI 2 months

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline to the entire treatment period in average pre-dose morning Peak Expiratory Flow.

    Measured: at 8 weeks

Secondary outcomes (8)

  1. Pre-dose morning FEV1 (Forced Expiratory Volume in one second);

    Measured: at 2, 4, 6 and 8 weeks of treatment

  2. Pre-dose morning FVC (Force Vital Capacity) ;

    Measured: at 2, 4, 6 and 8 weeks of treatment

  3. ACQ (Asthma Control Questionnaire) score ;

    Measured: at eight weeks

  4. pre-dose evening PEF ;

    Measured: at 2, 4, 6 and 8 weeks of treatment

  5. daily PEF variability ;

    Measured: at 2, 4, 6 and 8 weeks of treatment

  6. use of rescue medication ;

    Measured: at 2, 4, 6 and 8 weeks of treatment

  7. percentage of rescue use-free days

    Measured: at 2, 4, 6 and 8 weeks of treatment

  8. pre-dose morning PEF ;

    Measured: at 2, 4, 6 and 8 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

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
932 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01345916
Sponsor's protocol ID
CCD-1009-PR-0050
Other IDs
2010-023281-47
Acronym
Neptune
Status last verified
Mar 2017
First submitted
12 Apr 2011
Last updated
30 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • Kanniess F, Scuri M, Vezzoli S, Francisco C, Petruzzelli S. Extrafine beclomethasone/formoterol combination via a dry powder inhaler (NEXThaler((R))) or pMDI and beclomethasone monotherapy for maintenance of asthma control in adult patients: A randomised, double-blind trial. Pulm Pharmacol Ther. 2015 Feb;30:121-7. doi: 10.1016/j.pupt.2014.07.006. Epub 2014 Aug 1.

    PubMed 25088067

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CHF 1535 100/6 NEXT DPI® 2 months, CHF 1535 100/6 pMDI 2 months and BDP DPI 2 months in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Poland.

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 10 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 1 site in Poland. 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 the entire treatment period in average pre-dose morning Peak Expiratory Flow. (time frame: at 8 weeks). 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 NCT01345916, 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 30 Mar 2017.

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