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Real-world Effectiveness of Combination Therapy in Asthma

NCT01141465 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 815377

Last updated 2010-06-10

No results posted yet for this study

Summary

This study will evaluate and compare the effectiveness of asthma management in patients with evidence of persistent asthma following a switch in asthma therapy to combination inhaled glucocorticosteroid (ICS) / long-acting bronchodilator (LABA) therapy as either: fixed-combination fluticasone propionate / salmeterol (FP/SAL; Seretide®) via pressurised metered-dose inhaler (pMDI) or dry-powder inhaler (DPI) plus as-needed (prn) reliever therapy (salbutamol as DPI, BAI or pMDI), or fixed-combination budesonide / formoterol (BUD/FOR; Symbicort®) via DPI plus prn reliever therapy (salbutamol as DPI, BAI or pMDI or bricanyl as DPI). The final analysis plan will define exact comparators and age groups to be studied after reviewing baseline data.

Conditions

Interventions

DRUG

Fluticasone / formoterol metered dose inhaler

Prescribed at the same BDP-equivalent dose as baseline ICS

DRUG

Fluticasone / salmeterol dry powder inhaler

Prescribed at the same BDP-equivalent dose as baseline ICS

DRUG

Budesonide / formoterol dry powder inhaler

Prescribed at the same BDP-equivalent dose as baseline ICS

DRUG

Fluticasone / salmeterol dry powder inhaler

Prescribed at ≥twice BDP-equivalent dose as baseline ICS

DRUG

Fluticasone / salmeterol metred dose inhaler

Prescribed at ≥twice BDP-equivalent dose as baseline ICS

DRUG

BUD/FOR dry powder inhaler

Prescribed at ≥twice BDP-equivalent dose as baseline ICS

Sponsors & Collaborators

  • Mundipharma Research Limited

    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
4 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2007-06-30
Completion
2010-02-28

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT01141465 on ClinicalTrials.gov