Analysis of the Time Taken to Triple Therapy (NOVARTIS)

Analysis of the Time Taken for Newly Diagnosed COPD Patients to be Prescribed Triple Therapy

The proposed study will evaluate (for newly diagnosed Chronic Obstructive Pulmonary Disease (COPD) patients)the time taken to prescription of triple therapy by aiming to answer these following research questions:

1. The percentage of patients prescribed triple therapy, and when they first started receiving triple therapy.
2. For patients prescribed triple therapy, the time taken to triple therapy from initial diagnosis of COPD.
3. The variation in treatment pathways.
4. The factors associated with time taken to triple therapy.

Study Overview

• Status: Unknown
• Conditions: COPD

Detailed Description

Triple therapy consists of long-acting beta agonist (LABA) + inhaled corticosteroids (ICS) + long-acting muscarinic antagonist (LAMA) and typically should be reserved for patients who have severe to very severe (FEV1 <50%) COPD symptoms or for patients who have two or more exacerbations per year. However previous research from RiRL indicate that 50% of patients at GOLD stage II (moderate) receive ICS of which half were on triple therapy.

To allow for multiple analysis regarding the factors that influence the likelihood of being prescribed triple therapy, a bespoke COPD dataset will be created to include:

1. Disease severity markers:
2. Confirmation of a COPD diagnosis at initial date of COPD diagnosis
3. Standard co-morbidities fields
4. Demographic fields

This retrospective, observational study using data of COPD patients will assess treatment pathways (changes/step up) from initial date of COPD diagnosis with the prescription of triple therapy as the endpoint.

Specific questions that will be asked are:

1. Does the percentage of COPD patients prescribed triple therapy vary dependent on time of initial date of COPD diagnosis?
2. Does the time taken to the prescription of triple therapy vary dependent on initial date of COPD diagnosis?

• Study Type: Observational
• Enrollment (Actual): 20154

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB24 3BA
    • Research in Real Life Ltf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will have a QoF approved COPD read code and must be aged ≥ 40.

Description

Inclusion Criteria:

• Aged ≥40 years at initial date of COPD diagnosis
• COPD diagnosis with Quality Outcome Framework (QoF) approved read code
• has spirometry data supportive of a COPD diagnosis in the 5 years around initial date diagnosis of COPD (FEV1 % predicted)
• Patient has one year of data prior to initial date of COPD diagnosis
• Patient has a minimum of two years of data post initial date of COPD diagnosi

Exclusion Criteria:

• Patients whose initial date of COPD diagnosis is before 1997

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Prior Triple Therapy; Patients prescribed triple therapy prior to initial date of COPD diagnosis
Triple therapy at COPD diagnosis; Patients prescribed triple therapy on date of initial COPD diagnosis
Triple therapy after COPD diagnosis; Patients prescribed triple therapy after initial date of COPD diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triple Therapy Status	The proportion of patients prescribed triple therapy and whether they were prescribed it prior to, at, or after initial date of COPD diagnosis.	1 year
Initial date of COPD diagnosis	The date that patients were initially diagnosed with COPD. Categorised into cohorts- 1997-2001, 2002-2006, 2007-2010.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung function grade	Patient lung function grade, calculated by GOLD I, II, III, IV criteria.	1 year
Asthma Diagnosis	Proportion of patients with a co-morbid asthma diagnosis	1 year
COPD patient group	Patients COPD patient group, calculated by GOLD A, B, C, D criteria dependent on symptoms and risk of patient.	1 year
COPD exacerbations (Clinical experience based)	Number of the following: (i) Asthma/copd-related*: a. Hospital attendance / admissions OR b. A&E attendance OR (ii) GP consultations for lower respiratory related tract infections	1 year
Smoking Status	Patient smoking status, taken from routine and questionnaire data	1 year
BMI	Patient BMI class	1 year
COPD co-morbidities	COPD co-morbidities are identified via Read codes that are recorded at any time. Co-morbidities are: GERD, Rhinitis, Heart Failure, Ischaemic Heart Disease, Diabetes, Osteoporosis, Chronic Renal Failure, Chronic Kidney Disease and Anxiety-Depression	1 year

Collaborators and Investigators

• Sponsor: Research in Real-Life Ltd
• Collaborators: Novartis Pharmaceuticals
• Investigators: Principal Investigator: David Price, Prof, MD, University of Aberdeen

Publications and helpful links

General Publications

• Price D, Yawn B, Brusselle G, Rossi A. Risk-to-benefit ratio of inhaled corticosteroids in patients with COPD. Prim Care Respir J. 2013 Mar;22(1):92-100. doi: 10.4104/pcrj.2012.00092.
• Price D, Crockett A, Arne M, Garbe B, Jones RC, Kaplan A, Langhammer A, Williams S, Yawn BP. Spirometry in primary care case-identification, diagnosis and management of COPD. Prim Care Respir J. 2009 Sep;18(3):216-23. doi: 10.4104/pcrj.2009.00055.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): April 1, 2014
• Study Completion (Anticipated): April 1, 2014

Study Registration Dates

• First Submitted: February 6, 2013
• First Submitted That Met QC Criteria: February 6, 2013
• First Posted (Estimate): February 8, 2013

Study Record Updates

• Last Update Posted (Estimate): May 1, 2014
• Last Update Submitted That Met QC Criteria: April 30, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: COPD; ICS; LABA; LAMA; Triple Therapy
• Other Study ID Numbers: R04512