Early Diagnosis of Pulmonary Fibrosis - Diagnostic Delay

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Early Diagnosis of Pulmonary Fibrosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02772549
• Other study ID #: DELAY
• Status: Active, not recruiting
• Start date: March 2016
• Est. completion date: December 2028

Study information

• Verified date: December 2023
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Patients with newly diagnosed IPF are investigated for the diagnostic delay before a diagnosis of IPF is made.

Description:

Pulmonary fibrosis can be secondary to connective-tissue disease, environmental exposure, or drug toxicity, but it can also appear sporadically without any known cause, i.e. idiopathic interstitial pneumonitis (IIP). Idiopathic pulmonary fibrosis (IPF) is the commonest IIP and usually follows a rapidly progressive course with a short median survival time. IPF is often diagnosed after a long diagnostic delay, which also affects the prognosis. As new anti-fibrotic treatments have been approved, and awareness of IPF is rising, the diagnostic delay and its implications can be expected to be changing. Also, the new diagnostic guidelines of 2011 could change the diagnostic delay. In order to reduce the diagnostic delay, it is important to investigate the health care utilization and decisions made by healthcare professionals in the period before the final diagnosis is made. This study will prospectively include all patients at the two centres in Denmark where patients are treated for IPF and has thus a good opportunity to include the majority of incident cases of IPF in Denmark. Patients are included immediately after the diagnosis which reduces recall bias. The database will include both patient reported data and objective data from national registries and patient records. A main focus is the distribution of the diagnostic delay between patient and different health care providers, and the health care utilization by the patients before a diagnosis of IPF is made. Risk factors for a delayed diagnosis are investigated. The importance of the diagnostic delay for the prognosis and the course of the disease will also be investigated. The database created in this study will also be used for future research in IPF.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2028
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of IPF according to international guidelines

Exclusion Criteria:

• Unable to provide written informed consent
• Age below 18 years

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Gentofte Hospital	Hellerup	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Nils Hoyer	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnostic delays	Diagnostic delay subdivided into patient related delays and health care related delays.	1 year
Primary	Number of patients who fulfil any of the following: disease progression or death		1 year
Secondary	Number of patients who fulfill any of the following: decrease in lung function, reduced walking distance at 6 minutes walking test, increased need for supplementary oxygen, hospitalization		1 year
Secondary	All-cause and disease-specific mortality		1 year
Secondary	Number of respiratory and non-respiratory hospitalizations		1 year
Secondary	Decrease in walking distance at the 6 minute walking test		1 year
Secondary	Change in St. George Respiratory Questionnaire symptom scores		1 year
Secondary	Reduction in diffusion capacity (DLCO) or forced vital capacity (FVC)		1 year