Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management (Fos/Ser_switch)

This study has been completed.
Sponsor:
Collaborator:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
Alison Chisholm, Research in Real-Life Ltd
ClinicalTrials.gov Identifier:
NCT01242098
First received: November 11, 2010
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Asthma
Drug: Fixed dose combination salmeterol / fluticasone
Drug: Fixed-dose combination beclometasone dipropionate / formoterol

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective, Real-life Observational, Matched Cohort Evaluation of the Effectiveness of BDP/FOR (Fostair® 100/6) and FP/SAL (Seretide® 125) in Patients Switching From Seretide to Fostair in UK Primary Care Asthma Management

Resource links provided by NLM:


Further study details as provided by Research in Real-Life Ltd:

Primary Outcome Measures:
  • Exacerbation rate [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Exacerbation control (a composite proxy measure) [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]

    Controlled:

    Absence of:

    (i) Asthma-related:

    1. Hospital attendance or admission
    2. A&E attendance, OR
    3. Out of hours consultations, OR
    4. Out-patient department attendance

    (ii) GP consultations for lower respiratory tract infection

    (iii) Prescriptions for acute courses of oral steroids


  • Treatment success 1 [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]

    (i) Exacerbation control

    AND

    (ii) No change in therapeutic regimen:

    • ≥50% increase in ICS dose relative to IPD dose, and/or
    • Change in ICS/LABA drug within class, and/or
    • Change in delivery device, and/or
    • Use of additional (defined as not received during baseline year) therapy as defined by: theophylline, leukotriene receptor antagonists (LTRAs).

  • Asthma hospitalisations [ Time Frame: One-year outcome period ] [ Designated as safety issue: Yes ]
    1. Definite: Hospitalisations coded with an asthma read code
    2. Definite + Probable: Hospitalisations with an asthma read code + uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of an asthma read code

  • Compliance with ICS/LABA therapy [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]
    Compliance calculation based on prescription refills and (where possible) compliance questionnaire data

  • Use of reliever medication [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]
    average daily dosage during outcome year. Outcome SABA usage will be categorised within ranges used to match baseline SABA use to optimise matching of the treatment arms.

  • Cost of therapeutic regimen. [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]
    Mean healthcare costs (drug costs + consultation, admission costs, etc - total and respiratory-related) per patient recorded during the outcome year

  • Asthma-related / respiratory hospitalisations [ Time Frame: one year outcome period ] [ Designated as safety issue: No ]
    1. Definite: Hospitalisations coded with a lower respiratory code
    2. Definite + Probable: Hospitalisations with an asthma read code + uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of a lower respiratory read code

  • Oral Thrush [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]

    Identified as:

    (i) Topical oral anti-fungal prescriptions, and / or

    (ii) Coded for oral candidiasis



Enrollment: 137
Study Start Date: January 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy
Other Name: BDP/FOR; Fostair® 100/6
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
Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy
Other Name: FP/SAL; Seretide® 125

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.

Criteria

Inclusion Criteria:

  • Aged:

    • 18-60 years:
    • 61-80 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).

Exclusion Criteria:

  • Any chronic respiratory disease other than asthma
  • Are receiving maintenance oral steroid therapy during baseline period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242098

Locations
United Kingdom
Optimum Patient Care
Cawston, Norfolk, United Kingdom, NR10 4FE
Sponsors and Collaborators
Research in Real-Life Ltd
Chiesi Farmaceutici S.p.A.
  More Information

Additional Information:
No publications provided

Responsible Party: Alison Chisholm, David Price, Research in Real-Life Ltd
ClinicalTrials.gov Identifier: NCT01242098     History of Changes
Other Study ID Numbers: 004/11
Study First Received: November 11, 2010
Last Updated: June 7, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Research in Real-Life Ltd:
Asthma
Combination therapy
Primary care management
Switch
ICS/LABA
Fostair
Seretide

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Beclomethasone
Fluticasone, salmeterol drug combination
Formoterol
Salmeterol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents

ClinicalTrials.gov processed this record on July 23, 2014