NCT01141465

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
815,377

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2010

Completed
Last Updated

June 10, 2010

Status Verified

June 1, 2010

Enrollment Period

6.4 years

First QC Date

June 9, 2010

Last Update Submit

June 9, 2010

Conditions

Asthma

Keywords

Primary careAsthma managementCombined therapyReal-worldEffectivenessControlExacerbations

Outcome Measures

Primary Outcomes (4)

  • Composite proxy for asthma control

    * No recorded hospital attendance for asthma, including admission, Accident \& Emergency (A\&E) attendance, out-of-hours attendance, or Out-Patient Department (OPD) attendance, AND * No prescriptions for oral steroids, AND * No GP consultations, hospital admissions or A\&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics.

    One-year outcome period

  • Exacerbations (total and rate ratio)

    * Unscheduled hospital admissions / A\&E attendance for asthma, AND/OR * Use of oral steroids.

    One-year outcome period

  • GOAL Total Control (proxy measure to replicate total control as measured in the GOAL RCT in a real world patient population

    * No day-time symptoms; * No night-time symptoms; * No exacerbations; * No treatment-related adverse events * PEF ≥80% predicted = "normal" * No SABA use

    6 months (sensitivity analysis at 8 weeks)

  • GOAL exacerbations

    Absence of: * Documented episodes of hospitalisations AND/OR * Exacerbation treatment - oral steroids or antibiotics for asthma over one year

    One year

Secondary Outcomes (4)

  • Compliance with ICS/LABA combination therapy

    One year outcome period

  • Compliance with ICS as part of ICS/LABA combination therapy

    One-year outcome period

  • Treatment success

    One-year outcome period

  • SABA dosage

    One-year outcome period

Study Arms (6)

IPDA FP/SAL DPI

Patients who were on inhaled corticosteroid therapy during the baseline year (any ICS therapy) who, at an index prescription date, initiated combination therapy as FP/SAL DPI at ≥twice the equivalent BDP-equivalent dose

Drug: Fluticasone / salmeterol dry powder inhaler

IPDA FP/SAL MDI

Patients who were on inhaled corticosteroid therapy during the baseline year (any ICS therapy) who, at an index prescription date, initiated combination therapy as FP/SAL MDI at ≥twice the equivalent BDP-equivalent dose

Drug: Fluticasone / salmeterol metred dose inhaler

IPDI FP/SAL DPI

Patients who were on inhaled corticosteroid therapy during the baseline year (any ICS therapy) who, at an index prescription date, initiated combination therapy as FP/SAL DPI at equivalent BDP-equivalent dose

Drug: Fluticasone / salmeterol dry powder inhaler

IPDI BUD/FOR DPI

Patients who were on inhaled corticosteroid therapy during the baseline year (any ICS therapy) who, at an index prescription date, initiated combination therapy as BUD/FOR DPI at equivalent BDP-equivalent dose

Drug: Budesonide / formoterol dry powder inhaler

IPDI FP/SAL MDI

Patients who were on inhaled corticosteroid therapy during the baseline year (any ICS therapy) who, at an index prescription date, initiated combination therapy as FP/SAL MDI at equivalent BDP-equivalent dose

Drug: Fluticasone / formoterol metered dose inhaler

IPDA BUD/FOR DPI

Patients who were on inhaled corticosteroid therapy during the baseline year (any ICS therapy) who, at an index prescription date, initiated combination therapy as BUD/FOR DPI at ≥twice the equivalent BDP-equivalent dose

Drug: BUD/FOR dry powder inhaler

Interventions

Fluticasone / formoterol metered dose inhalerDRUG

Prescribed at the same BDP-equivalent dose as baseline ICS

Also known as: Seretide MDI
IPDI FP/SAL MDI
Fluticasone / salmeterol dry powder inhalerDRUG

Prescribed at the same BDP-equivalent dose as baseline ICS

Also known as: Seretide DPI
IPDI FP/SAL DPI
Budesonide / formoterol dry powder inhalerDRUG

Prescribed at the same BDP-equivalent dose as baseline ICS

Also known as: Symbicort DPI
IPDI BUD/FOR DPI
Fluticasone / salmeterol metred dose inhalerDRUG

Prescribed at ≥twice BDP-equivalent dose as baseline ICS

Also known as: Seretide MDI
IPDA FP/SAL MDI
BUD/FOR dry powder inhalerDRUG

Prescribed at ≥twice BDP-equivalent dose as baseline ICS

Also known as: Symbicort DPI
IPDA BUD/FOR DPI

Eligibility Criteria

Age4 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care asthma patients receiving ICS therapy (any of BDP, extrafine HFA-BDP, BUD or FP as pMDI, BAI or DPI) plus as needed SABA reliever therapy who underwent a change in asthma therapy to combination ICS/LABA therapy as FP/SAL (MDI or DPI) or BUD/FOR (DPI) at the same or at least twice the BDP-equivalent dose of ICS prescribed during baseline.

You may qualify if:

  • Aged: 4-80 years: Paediatric cohort (aged 4-11 years); Adult cohort (aged 12-69 years); Elderly cohort (aged 70-80 years.
  • Evidence of asthma: i.e. a diagnostic code of asthma or ≥2 prescriptions for asthma at different points in time during the prior year, including one ICS prescription.
  • Be on current asthma therapy: i.e. ≥1 asthma prescriptions in the prior year, and at least 1 other asthma prescription during the same period.
  • Have at least one year of up-to-standard (UTS) baseline data (prior to the IPD) and at least one year of UTS outcome data (following the IPD).

You may not qualify if:

  • Diagnostic read code for chronic respiratory disease (including COPD) at any time
  • On maintenance oral steroid therapy at baseline
  • Any patients receiving a combination inhaler in addition to their separate ICS inhaler in the baseline year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Practice Research Database

London, SW8 5NQ, United Kingdom

Location

Related Publications (5)

  • Herland K, Akselsen JP, Skjonsberg OH, Bjermer L. How representative are clinical study patients with asthma or COPD for a larger "real life" population of patients with obstructive lung disease? Respir Med. 2005 Jan;99(1):11-9. doi: 10.1016/j.rmed.2004.03.026.

    PMID: 15672843BACKGROUND

  • Travers J, Marsh S, Caldwell B, Williams M, Aldington S, Weatherall M, Shirtcliffe P, Beasley R. External validity of randomized controlled trials in COPD. Respir Med. 2007 Jun;101(6):1313-20. doi: 10.1016/j.rmed.2006.10.011. Epub 2006 Nov 17.

    PMID: 17113277BACKGROUND

  • Appleton SL, Adams RJ, Wilson DH, Taylor AW, Ruffin RE; North West Adelaide Cohort Health Study Team. Spirometric criteria for asthma: adding further evidence to the debate. J Allergy Clin Immunol. 2005 Nov;116(5):976-82. doi: 10.1016/j.jaci.2005.08.034.

    PMID: 16275363BACKGROUND

  • Bateman ED, Boushey HA, Bousquet J, Busse WW, Clark TJ, Pauwels RA, Pedersen SE; GOAL Investigators Group. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am J Respir Crit Care Med. 2004 Oct 15;170(8):836-44. doi: 10.1164/rccm.200401-033OC. Epub 2004 Jul 15.

    PMID: 15256389BACKGROUND

  • British Thoracic Society (BTS) Scottish Intercollegiate Guidelines Network (SIGN) 101. British Guideline on the Management of Asthma: a national clinical guideline. 2008. Available online at: www.sign.ac.uk/guidelines/fulltext/101/index.html

    BACKGROUND

Related Links

MeSH Terms

Conditions

Asthma

Interventions

FluticasoneBudesonide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnenedionesPregnenesPregnanes

Study Officials

  • David Price, Prof. MD

    Company Director

    PRINCIPAL INVESTIGATOR

  • Alison Chisholm, MSc

    Research Project Director

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK

Study Record Dates

First Submitted

June 9, 2010

First Posted

June 10, 2010

Study Start

January 1, 2001

Primary Completion

June 1, 2007

Study Completion

February 1, 2010

Last Updated

June 10, 2010

Record last verified: 2010-06

Locations

GB(1)