Overview

This trial is active, not recruiting.

Condition copd
Sponsor Research in Real-Life Ltd
Collaborator Novartis Pharmaceuticals
Start date October 2012
End date April 2014
Trial size 20154 participants
Trial identifier NCT01786720, R04512

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Patients prescribed triple therapy prior to initial date of COPD diagnosis
Patients prescribed triple therapy on date of initial COPD diagnosis
Patients prescribed triple therapy after initial date of COPD diagnosis

Primary Outcomes

Measure
Triple Therapy Status
time frame: 1 year
Initial date of COPD diagnosis
time frame: 1 year

Secondary Outcomes

Measure
Lung function grade
time frame: 1 year
Asthma Diagnosis
time frame: 1 year
COPD patient group
time frame: 1 year
COPD exacerbations (Clinical experience based)
time frame: 1 year
Smoking Status
time frame: 1 year
BMI
time frame: 1 year
COPD co-morbidities
time frame: 1 year

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official title Analysis of the Time Taken for Newly Diagnosed COPD Patients to be Prescribed Triple Therapy
Principal investigator David Price, Prof, MD
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?
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Research in Real-Life Ltd.