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Real-world Effectiveness and Cost-effectiveness of HFA-beclometasone Compared With ICS/LABA Combination Therapy

NCT01697722 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 815377

Last updated 2012-10-04

No results posted yet for this study

Summary

This study will compare the effectiveness, cost-effectiveness and direct healthcare costs of asthma management in patients with evidence of persistent asthma following an increase in asthma therapy in the form of either an increased dose of inhaled glucocorticosteroids (ICS) using extrafine hydrofluoroalkane-beclometasone dipropionate (HFA-BDP) via pressurised metered-dose inhaler (pMDI) or breath-actuated inhaler (BAI), or a change to combination ICS plus long-acting bronchodilator (LABA) therapy using fixed combinations (fluticasone propionate / salmeterol \[FP/SAL\] or budesonide / formoterol \[BUD/FOR\]) or separate pMDIs and BAIs.

Conditions

Interventions

DRUG

Extra-fine hydrofluoroalkane-beclometasone dipropionate

Increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via pMDI or BAI

DRUG

ICS / LABA via separate pMDI and / or BAI inhalers

A step-up from baseline ICS therapy via the addition of a separate long-acting beta-agonist with no change in baseline ICS drug or dose

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    collaborator INDUSTRY

  • Research in Real-Life Ltd

    lead NETWORK

Principal Investigators

  • David Price, Prof. MD · Company Director

  • Alison Chisholm, MSc · Research Project Director

Eligibility

Min Age
5 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1991-01-31
Primary Completion
2007-06-30
Completion
2010-02-28

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01697722 on ClinicalTrials.gov