A Study in Patients With Asthma

Asthma Clinical Trial

— NELSON  

Official title:

A 12-week, Multicenter, Randomized, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of Foster® NEXThaler® (Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg/Actuation), 2 Inhalations b.i.d., Versus Seretide® Accuhaler® (Fluticasone 250 µg Plus Salmeterol 50 µg/Actuation), 1 Inhalation b.i.d., on Small Airway Derived Parameters in Patients With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570478
• Other study ID #: MC/PR/15009/001/11
• Secondary ID: 2011-003449-17
• Status: Completed
• Phase: Phase 3
• First received: March 28, 2012
• Last updated: March 28, 2017
• Start date: July 2012
• Est. completion date: February 2014

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 the present study is to demonstrate the higher efficacy of Foster® NEXThaler® 100/6 extra fine (two inhalations b.i.d.) versus Seretide® Accuhaler® 250/50 (one inhalation b.i.d.), in terms of pulmonary function (change from baseline to the end of treatment in post-dose peripheral airway resistance) in patients with asthma.

Description:

Asthma is a chronic inflammatory disease characterised by variable airflow obstruction and bronchial hyper responsiveness. Asthma affects both the large and the small airways and there is a growing body of evidence that small airways impairment is an important contributor to the pathogenesis and clinical expression of the disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female outpatients aged = 18, who have signed an Informed Consent form prior to initiation of any study-related procedure.

• Clinical diagnosis of asthma for a minimum of 12 months prior to screening confirmed by a chest physician according to international guidelines (GINA). The evidence of asthma must be confirmed through a documented (in the last three years) positive response to the reversibility test, defined as ?FEV1 = 12% and = 200 mL over baseline, within 30 minutes after administration of 400 µg of salbutamol pMDI or through a documented (in the last three years) positive response to methacholine challenge test (PC20 < 8 mg/mL or PD20 < 1 mg).

• Baseline FEV1 > 80% of the predicted normal value after appropriate washout from bronchodilators (to be checked at screening and at randomisation visits).

• Asthma Control Test score = 20 and < 25 (to be checked at screening and at randomisation visits).

• Impaired small airways function defined as baseline peripheral airway resistance [R(5Hz)-R(20Hz)] = 0.07 kPa/L/s (to be checked at screening and at randomisation visits).

• Patients on previous regular treatment with Seretide® Accuhaler® (fluticasone propionate 250 µg plus salmeterol xinafoate 50 µg per actuation, daily dose of fluticasone 500 µg plus salmeterol 100 µg) at a stable dose for at least 2 months prior to inclusion.

• A cooperative attitude and ability to be trained to the proper use of DPI.

Main Exclusion Criteria:

• Patients with a diagnosis of COPD according to GOLD guidelines.

• Current smokers with a smoking history of > 10 pack/year.

• Patients who have a clinical or functional uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that might, in the judgment of the investigator, represent for the patients an undue risk or that could compromise the results or interpretation of the study.

• History or current evidence of uncontrolled heart failure, clinically relevant coronary artery disease, recent myocardial infarction, severe hypertension, uncontrolled cardiac arrhythmias.

• Patients treated with LABA or ICS/LABA fixed combination in the 24 hours before the screening visit.

• Severe asthma exacerbation leading to intake of systemic corticosteroids (> 10 days) in the month before the screening visit.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Foster® NEXThaler® 100/6 µg/unit dose
Foster® NEXThaler® (beclomethasone dipropionate 100 µg plus formoterol 6 µg per actuation), 2 inhalations b.i.d. (daily dose of BDP 400 µg plus FF 24 µg)
• Seretide® Accuhaler® 250/50 µg/actuation
Seretide® Accuhaler® (fluticasone propionate 250 µg plus salmeterol xinafoate 50 µg per actuation), 1 inhalation b.i.d. (daily dose of fluticasone 500 µg plus salmeterol 100 µg)

Locations

Country	Name	City	State
Italy	Dipartimento Cardio-Polmonare - Azienda Ospedaliero-Universitaria - Padiglione Rasori	Parma

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to end of treatment in post-dose peripheral airway resistance [R(5Hz)-R(20Hz)].		Baseline and 3 months
Secondary	Changes from baseline at each clinic visit in pre and post-dose Impulse Oscillometry (IOS)/plethysmographic/spirometric parameters		After 4, 8, 12 weeks of treatment
Secondary	Asthma exacerbations (severe)		Up to 12 weeks of treatment
Secondary	Clinical measures of asthma control		Up to 12 weeks of treatment

External Links

•   Study Record on EU Clinical Trials Register including results