A Study in Patients With Asthma

NCT01570478 | Completed Phase 3

• 2 other identifiers: MC/PR/15009/001/112011-003449-17
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Change from baseline to end of treatment in post-dose peripheral airway resistance [R(5Hz)-R(20Hz)].

  Baseline and 3 months

Secondary Outcomes (3)

• 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

• Asthma exacerbations (severe)

  Up to 12 weeks of treatment

• Clinical measures of asthma control

  Up to 12 weeks of treatment

Study Arms (2)

Foster® NEXThaler®

EXPERIMENTAL

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

Seretide® Accuhaler®

ACTIVE COMPARATOR

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

Interventions

Foster® NEXThaler® 100/6 µg/unit dose DRUG

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)

Foster® NEXThaler®

Seretide® Accuhaler® 250/50 µg/actuation DRUG

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)

Seretide® Accuhaler®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Dipartimento Cardio-Polmonare - Azienda Ospedaliero-Universitaria - Padiglione Rasori

Parma, 43100, Italy

Location

Related Publications (1)

• Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

  PMID: 36472162 DERIVED

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Alfredo Chetta, MD

  Dept. of Cardiology and Pulmonary Medicine - Pama, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 4, 2012
• Study Start: July 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

IT (1)