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

Asthma Clinical Trial

— Neptune  

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®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01345916
• Other study ID #: CCD-1009-PR-0050
• Secondary ID: 2010-023281-47
• Status: Completed
• Phase: Phase 3
• First received: April 12, 2011
• Last updated: March 28, 2017
• Start date: March 2011
• Est. completion date: August 2011

Study information

• Verified date: March 2017
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 932
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male and female adults (=18 years old).

2. Reversibility test defined as ?FEV1 = 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 .

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CHF 1535 100/6 NEXT DPI® 2 months
CHF 1535 100/6 NEXT DPI® 2 months
• CHF 1535 100/6 pMDI 2 months
CHF 1535 100/6 pMDI 2 months
• BDP DPI 2 months
BDP DPI 2 months

Locations

Country	Name	City	State
Poland	GSPZOZ Uniwersytecki Szpital Kliniczny	Lódz

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Kanniess F, Scuri M, Vezzoli S, Francisco C, Petruzzelli S. Extrafine beclomethasone/formoterol combination via a dry powder inhaler (NEXThaler(®)) or pMDI and beclomethasone monotherapy for maintenance of asthma control in adult patients: A randomised, d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to the entire treatment period in average pre-dose morning Peak Expiratory Flow.		at 8 weeks
Secondary	Pre-dose morning FEV1 (Forced Expiratory Volume in one second);		at 2, 4, 6 and 8 weeks of treatment
Secondary	Pre-dose morning FVC (Force Vital Capacity) ;		at 2, 4, 6 and 8 weeks of treatment
Secondary	ACQ (Asthma Control Questionnaire) score ;		at eight weeks
Secondary	pre-dose evening PEF ;		at 2, 4, 6 and 8 weeks of treatment
Secondary	daily PEF variability ;		at 2, 4, 6 and 8 weeks of treatment
Secondary	use of rescue medication ;		at 2, 4, 6 and 8 weeks of treatment
Secondary	percentage of rescue use-free days		at 2, 4, 6 and 8 weeks of treatment
Secondary	pre-dose morning PEF ;		at 2, 4, 6 and 8 weeks of treatment

External Links

•   Study Record on EU Clinical Trials Register including results