NCT01908075

Brief Summary

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

100
On Track

Trial Health Score

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

Enrollment
194,723

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

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, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
Last Updated

July 25, 2013

Status Verified

July 1, 2013

Enrollment Period

2.2 years

First QC Date

July 23, 2013

Last Update Submit

July 24, 2013

Conditions

Asthma

Keywords

Primary careAsthma managementReal-worldObservationalFostairSeretide

Outcome Measures

Primary Outcomes (1)

  • Exacerbations : rate ratio

    Where an exacerbation is defined as: (i) Asthma-related 1. Hospital attendance / admissions OR 2. Accident \& Emergency (A\&E) attendance OR (ii) Use of acute oral steroids. Where: * ≥1 oral steroid prescription occurs within 2 weeks of another, or * ≥1 hospitalisation occurs within 2 weeks of another, or * ≥1 hospitalisation occurs within 2 weeks of an oral steroid prescription

    1 year

Secondary Outcomes (6)

  • Exacerbation control

    1 year

  • Proxy asthma control + SABA

    1 year

  • Treatment success

    1 year

  • Asthma Control (including SABA)

    1 year

  • Hospitalisations

    1 year

  • +1 more secondary outcomes

Study Arms (2)

BDP/FOR

Patients receiving ICS/LABA therapy as FP/SAL (Seretide®) who, at an index prescription date (IPD): Change their therapy to BDP/FOR (Fostair®) at same or lower BDP-equivalent ICS dose

Drug: FP/SALDrug: BDP/FOR

FP/SAL

Patients receiving ICS/LABA therapy as FP/SAL (Seretide®) who, at an index prescription date (IPD) : Remain on FP/SAL at the same BDP-equivalent ICS dose

Drug: FP/SAL

Interventions

FP/SALDRUG
Also known as: Seretide®
BDP/FORFP/SAL
BDP/FORDRUG
Also known as: Fostair® 100/6
BDP/FOR

Eligibility Criteria

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

All patients are diagnosed with asthma or COPD and aged between 18-80 years with all 61-80 year olds being non-smokers only

You may qualify if:

  • Aged: 18-80 years 61-80 years to be non-smokers only
  • Evidence of asthma: a diagnostic code for asthma or two scripts for asthma..
  • Baseline FP/SAL therapy: ≥2 prescription for ICS/LABA therapy as FP/SAL
  • Evidence of Continuing Therapy: Include only patients who receive ≥2 prescriptions for the therapy under study during the outcome year (i.e. ≥1 prescription at the index date and ≥1 other). UK average is 3-4 prescriptions refilled per year, so ≥2 ensures capture of "real-life" data.

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

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Salmeterol XinafoateAlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesFluticasoneAndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • David Price

    University of Aberdeen

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 23, 2013

First Posted

July 25, 2013

Study Start

January 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

July 25, 2013

Record last verified: 2013-07