Clinical trial NCT01786720: Analysis of the Time Taken to Triple Therapy (NOVARTIS)
Official title: Analysis of the Time Taken for Newly Diagnosed COPD Patients to be Prescribed Triple Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Keywords: COPD
Triple Therapy
ICS
LABA
LAMA
Lead sponsor: Research in Real-Life Ltd
Sponsor class: NETWORK
Collaborators: name: Novartis Pharmaceuticals
First posted: 2013-02-08
Enrollment: 20154
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will have a QoF approved COPD read code and must be aged ≥ 40.

Brief 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.

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?

Eligibility criteria: 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

Primary outcomes:
measure: Triple Therapy Status
timeFrame: 1 year
measure: Initial date of COPD diagnosis
timeFrame: 1 year
Secondary outcomes:
measure: Lung function grade
timeFrame: 1 year
measure: Asthma Diagnosis
timeFrame: 1 year
measure: COPD patient group
timeFrame: 1 year
measure: COPD exacerbations (Clinical experience based)
timeFrame: 1 year
measure: Smoking Status
timeFrame: 1 year
measure: BMI
timeFrame: 1 year
measure: COPD co-morbidities
timeFrame: 1 year
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Research in Real Life Ltf
Study officials:
affiliation: University of Aberdeen
name: David Price, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.