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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: CHF 1535 100/6 NEXT DPI® 2 months; Drug: CHF 1535 100/6 pMDI 2 months; Drug: BDP DPI 2 months

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.

• Study Type: Interventional
• Enrollment (Actual): 932
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Łódź, Poland, 90-153
    • GSPZOZ Uniwersytecki Szpital Kliniczny

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female adults (≥18 years old).
2. Reversibility test defined as ΔFEV1 ≥ 12% and ≥ 200 mL .
3. FEV1 > 80% of the predicted values .
4. Asthma Control Questionnaire score < 1.25.
5. Asthmatic patients
6. Non- or ex-smokers

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHF 1535 100/6 NEXT Dry Powder Inhaler®; CHF1535 100/6 NEXT DPI® 1 inhalation bis in day (b.i.d) (daily dose BDP 200/FF 12 µg)	Drug: CHF 1535 100/6 NEXT DPI® 2 months; CHF 1535 100/6 NEXT DPI® 2 months
Active Comparator: CHF1535 100/6 pMDI; CHF1535 100/6 pressurisedMeterDoseInhaler 1 inhalation b.i.d (total daily dose BDP 200/FF 12 µg)	Drug: CHF 1535 100/6 pMDI 2 months; CHF 1535 100/6 pMDI 2 months; Other Names: Foster®
Active Comparator: beclomethasone dipropionate DPI; beclomethasone dipropionate 100 µg DPI, 1 inhalation b.i.d (total daily dose BDP 200 µg)	Drug: BDP DPI 2 months; BDP DPI 2 months; Other Names: Clenil® Pulvinal®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to the entire treatment period in average pre-dose morning Peak Expiratory Flow.	at 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Pre-dose morning FEV1 (Forced Expiratory Volume in one second);	at 2, 4, 6 and 8 weeks of treatment
Pre-dose morning FVC (Force Vital Capacity) ;	at 2, 4, 6 and 8 weeks of treatment
ACQ (Asthma Control Questionnaire) score ;	at eight weeks
pre-dose evening PEF ;	at 2, 4, 6 and 8 weeks of treatment
daily PEF variability ;	at 2, 4, 6 and 8 weeks of treatment
use of rescue medication ;	at 2, 4, 6 and 8 weeks of treatment
percentage of rescue use-free days	at 2, 4, 6 and 8 weeks of treatment
pre-dose morning PEF ;	at 2, 4, 6 and 8 weeks of treatment

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Investigators: Principal Investigator: Frank KANNIESS, Dr, Gemeinschaftspraxis Reinfeld - Raiffeisenpassage 15 - D-23858 Reinfeld - Germany

Publications and helpful links

General 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.

Helpful Links

• Study Record on EU Clinical Trials Register including results

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: April 12, 2011
• First Submitted That Met QC Criteria: April 29, 2011
• First Posted (Estimate): May 2, 2011

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: CCD-1009-PR-0050; 2010-023281-47 (EudraCT Number)