Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT01786720
Status:
UNKNOWN
Last Update Posted:
2014-05-01
First Post:
2013-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of the Time Taken to Triple Therapy (NOVARTIS)
Sponsor:
Research in Real-Life Ltd
Organization:
Study Overview
Official Title:
Analysis of the Time Taken for Newly Diagnosed COPD Patients to be Prescribed Triple Therapy
Status:
UNKNOWN
Status Verified Date:
2014-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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?
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: