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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01345916
First received: April 12, 2011
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: CHF 1535 100/6 NEXT DPI® 2 months
Drug: CHF 1535 100/6 pMDI 2 months
Drug: BDP DPI 2 months
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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®

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Change from baseline to the entire treatment period in average pre-dose morning Peak Expiratory Flow. [ Time Frame: at 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pre-dose morning FEV1 (Forced Expiratory Volume in one second); [ Time Frame: at 2, 4, 6 and 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Pre-dose morning FVC (Force Vital Capacity) ; [ Time Frame: at 2, 4, 6 and 8 weeks of treatment ] [ Designated as safety issue: No ]
  • ACQ (Asthma Control Questionnaire) score ; [ Time Frame: at eight weeks ] [ Designated as safety issue: No ]
  • pre-dose evening PEF ; [ Time Frame: at 2, 4, 6 and 8 weeks of treatment ] [ Designated as safety issue: No ]
  • daily PEF variability ; [ Time Frame: at 2, 4, 6 and 8 weeks of treatment ] [ Designated as safety issue: No ]
  • use of rescue medication ; [ Time Frame: at 2, 4, 6 and 8 weeks of treatment ] [ Designated as safety issue: No ]
  • percentage of rescue use-free days [ Time Frame: at 2, 4, 6 and 8 weeks of treatment ] [ Designated as safety issue: No ]
  • pre-dose morning PEF ; [ Time Frame: at 2, 4, 6 and 8 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 932
Study Start Date: March 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Clenil® Pulvinal®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 .
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345916

Locations
Poland
GSPZOZ Uniwersytecki Szpital Kliniczny
Łódź, Poland, 90-153
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Frank KANNIESS, Dr Gemeinschaftspraxis Reinfeld - Raiffeisenpassage 15 - D-23858 Reinfeld - Germany
  More Information

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01345916     History of Changes
Other Study ID Numbers: CCD-1009-PR-0050, 2010-023281-47
Study First Received: April 12, 2011
Last Updated: February 14, 2012
Health Authority: Bulgaria: Bulgarian Drug Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Ukraine: State Pharmacological Center - Ministry of Health

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Beclomethasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 15, 2014