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A Study in Patients With Asthma (NELSON)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01570478
First Posted: April 4, 2012
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
  Purpose
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.

Condition Intervention Phase
Asthma Drug: Foster® NEXThaler® 100/6 µg/unit dose Drug: Seretide® Accuhaler® 250/50 µg/actuation Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline to end of treatment in post-dose peripheral airway resistance [R(5Hz)-R(20Hz)]. [ Time Frame: Baseline and 3 months ]

Secondary Outcome Measures:
  • Changes from baseline at each clinic visit in pre and post-dose Impulse Oscillometry (IOS)/plethysmographic/spirometric parameters [ Time Frame: After 4, 8, 12 weeks of treatment ]
  • Asthma exacerbations (severe) [ Time Frame: Up to 12 weeks of treatment ]
  • Clinical measures of asthma control [ Time Frame: Up to 12 weeks of treatment ]

Enrollment: 108
Study Start Date: July 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Foster® NEXThaler®
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)
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)
Active Comparator: Seretide® Accuhaler®
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)
Drug: 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)

Detailed 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.
  Eligibility

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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:

  • 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 ΔFEV1 ≥ 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.
  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): NCT01570478


Locations
Italy
Dipartimento Cardio-Polmonare - Azienda Ospedaliero-Universitaria - Padiglione Rasori
Parma, Italy, 43100
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Alfredo Chetta, MD Dept. of Cardiology and Pulmonary Medicine - Pama, Italy
  More Information

Additional Information:
Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01570478     History of Changes
Other Study ID Numbers: MC/PR/15009/001/11
2011-003449-17 ( EudraCT Number )
First Submitted: March 28, 2012
First Posted: April 4, 2012
Last Update Posted: March 29, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Beclomethasone
Formoterol Fumarate
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids