Analysis of the Time Taken to Triple Therapy (NOVARTIS)

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01786720
• Other study ID #: R04512
• Status: Active, not recruiting
• Phase: N/A
• First received: February 6, 2013
• Last updated: April 30, 2014
• Start date: October 2012
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Research in Real-Life Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial Summary

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.

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?

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20154
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• COPD

Locations

Country	Name	City	State
United Kingdom	Research in Real Life Ltf	Cambridge

Sponsors (2)

Lead Sponsor	Collaborator
Research in Real-Life Ltd	Novartis Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Lung function grade	Patient lung function grade, calculated by GOLD I, II, III, IV criteria.	1 year	No
Secondary	Asthma Diagnosis	Proportion of patients with a co-morbid asthma diagnosis	1 year	No
Secondary	COPD patient group	Patients COPD patient group, calculated by GOLD A, B, C, D criteria dependent on symptoms and risk of patient.	1 year	No
Secondary	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	No
Secondary	Smoking Status	Patient smoking status, taken from routine and questionnaire data	1 year	No
Secondary	BMI	Patient BMI class	1 year	No
Secondary	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	No