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

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ClinicalTrials.gov Identifier: NCT01345916
Recruitment Status : Completed
First Posted : May 2, 2011
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment 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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 932 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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®
Study Start Date : March 2011
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

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 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®


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline to the entire treatment period in average pre-dose morning Peak Expiratory Flow. [ Time Frame: at 8 weeks ]

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

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
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 ( EudraCT Number )
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Beclomethasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents