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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Beclomethasone
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014