NCT01242098

Brief Summary

The purpose of this study is to evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL; Seretide® 125) in matched asthma patients switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared with patients not switched.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

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, 2008

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 8, 2012

Status Verified

June 1, 2012

Enrollment Period

3.9 years

First QC Date

November 11, 2010

Last Update Submit

June 7, 2012

Conditions

Asthma

Keywords

AsthmaCombination therapyPrimary care managementSwitchICS/LABAFostairSeretide

Outcome Measures

Primary Outcomes (1)

  • Exacerbation rate

    Where an exacerbation is defined as: (i) Asthma-related 1. Hospital attendance / admissions OR 2. Accident \& Emergency (A\&E) attendance OR (ii) Use of oral steroids.

    One-year outcome period

Secondary Outcomes (8)

  • Exacerbation control (a composite proxy measure)

    One-year outcome period

  • Treatment success 1

    One-year outcome period

  • Asthma hospitalisations

    One-year outcome period

  • Compliance with ICS/LABA therapy

    One-year outcome period

  • Use of reliever medication

    One-year outcome period

  • +3 more secondary outcomes

Study Arms (2)

Fostair switch cohort

Seretide patients who, at an index date, had a step down in therapy (reduction in ICS dose of ≥50%) and switch to Fostair

Drug: Fixed-dose combination beclometasone dipropionate / formoterol

Seretide continuation cohort

Seretide patients who, at an index date, had a step down in therapy (reduction in ICS dose of ≥50%) and continue on Seretide

Drug: Fixed dose combination salmeterol / fluticasone

Interventions

Fixed dose combination salmeterol / fluticasoneDRUG

Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy

Also known as: FP/SAL; Seretide® 125
Seretide continuation cohort
Fixed-dose combination beclometasone dipropionate / formoterolDRUG

Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy

Also known as: BDP/FOR; Fostair® 100/6
Fostair switch cohort

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients receiving ICS/LABA therapy as FP/SAL (Seretide® 125) who, at an index prescription date (IPD) receive a routine asthma review\* and either: (i) Switched to BDP/FOR (Fostair®)at same or lower BDP-equivalent ICS dose; OR, (ii) Continues on FP/SAL (Seretide® 125) for the duration of the outcome period at the same or lower BDP-equivalent ICS dose prescribed at baseline.

You may qualify if:

  • Aged:
  • years:
  • years who are never-smokers
  • Evidence of asthma:
  • a diagnostic code for asthma, or
  • ≥2 prescriptions for asthma at different points in time during the prior year
  • Baseline FP/SAL therapy:
  • ≥2 prescription for ICS/LABA therapy as FP/SAL (Seretide® 125).

You may not qualify if:

  • Any chronic respiratory disease other than asthma
  • Are receiving maintenance oral steroid therapy during baseline period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Optimum Patient Care

Cawston, Norfolk, NR10 4FE, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Asthma

Interventions

FluticasoneFormoterol Fumarate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
David Price

Study Record Dates

First Submitted

November 11, 2010

First Posted

November 16, 2010

Study Start

January 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

June 8, 2012

Record last verified: 2012-06

Locations

GB(1)