Analysis of the Time Taken to Triple Therapy (NOVARTIS)

NCT01786720 | Unknown

• 1 other identifier: R04512
• Study Type: observational
• Target: 20,154
• Locations: 1 country
• Sites: 1

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

Conditions

COPD

Keywords

COPD; Triple Therapy; ICS; LABA; LAMA

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Lung function grade

  1 year

• Asthma Diagnosis

  1 year

• COPD patient group

  1 year

• COPD exacerbations (Clinical experience based)

  1 year

• Smoking Status

  1 year

Study Arms (3)

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patients whose initial date of COPD diagnosis is before 1997

Sponsors & Collaborators

• Research in Real-Life Ltd: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Research in Real Life Ltf

Cambridge, CB24 3BA, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 23135217 BACKGROUND

• 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.

  PMID: 19688142 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Price, Prof, MD

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 8, 2013
• Study Start: October 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 1, 2014

Record last verified: 2014-04

Locations

GB (1)