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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01242098
First Posted: November 16, 2010
Last Update Posted: June 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
Alison Chisholm, Research in Real-Life Ltd
  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

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

Primary Outcome Measures:
  • Exacerbation rate [ Time Frame: One-year outcome period ]

    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 ]

    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 ]

    (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 ]
    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 ]
    Compliance calculation based on prescription refills and (where possible) compliance questionnaire data

  • Use of reliever medication [ Time Frame: One-year outcome period ]
    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 ]
    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 ]
    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 ]

    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Alison Chisholm, David Price, Research in Real-Life Ltd
ClinicalTrials.gov Identifier: NCT01242098     History of Changes
Other Study ID Numbers: 004/11
First Submitted: November 11, 2010
First Posted: November 16, 2010
Last Update Posted: June 8, 2012
Last Verified: June 2012

Keywords provided by Alison Chisholm, 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
Formoterol Fumarate
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids