Exhaled Breath Condensate Biomarkers and Cough in IPF

NCT02630940 | Completed

• 1 other identifier: 152379 (113-08-15)
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Analysis of exhaled breath condensate biomarkers and cough severity in patients with idiopathic pulmonary fibrosis.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 8-isoprostane levels

  Used for detection of 8-isoprostane levels in patients' exhaled breath condensate samples

  1 day (Single measurement )

Secondary Outcomes (5)

• Leicester Cough Questionnaire

  1 day (Single measurement )

• Kings brief interstitial lung disease questionnaire

  1 day (Single measurement )

• MRC dyspnoea Scale

  1 day (Single measurement )

• Visual analogue scale for Cough

  1 day (Single measurement )

• Non-validated acceptability questionnaire

  1 day (Single measurement )

Study Arms (1)

Idiopathic pulmonary fibrosis sufferers

Male or female idiopathic pulmonary fibrosis (IPF) sufferers over the age of 40, with a confirmed diagnosis of IPF against international guidelines. Patients are devoid of significant other medical, surgical or psychiatric illnesses that may affect respiratory symptoms or disease progression.

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

Male or Female Idiopathic pulmonary fibrosis sufferers over the age of 40, who have been diagnosed in accordance with either a multi-disciplinary review of their clinical history, thoracic high resolution computed tomography and/or surgical lung according to international guidelines

You may qualify if:

• Male or female above the age of 40
• IPF diagnosed by a multi-disciplinary team meeting following review of clinical history, thoracic high resolution computed tomography (HRCT) and/or surgical lung according to international guidelines

You may not qualify if:

• A recognised significant co-existing respiratory disease, defined as a respiratory condition that exhibits a clinically relevant effect on respiratory symptoms and disease progression as determined by the principal investigator following multi-disciplinary discussion. For example, patients with bronchiectasis will only be included if the bronchiectasis is deemed to be traction bronchiectasis as a result of idiopathic pulmonary fibrosis
• Airflow obstruction defined as a forced expiratory volume at one second over forced vital capacity (FEV1/FVC) \<60% predicted or a residual volume greater than 120% predicted
• Significant medical ,surgical or psychiatric disease that in the opinion of the patient's attending physician would exhibit a clinically relevant effect on the patient's health related quality of life
• The patient is unable to provide written informed consent

Sponsors & Collaborators

• University of East Anglia: lead

Study Sites (1)

University of East Anglia

Norwich, Norfolk, NR47TJ, United Kingdom

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Andrew M Wilson, MD MRCP

  University of East Anglia

  PRINCIPAL INVESTIGATOR

• Christopher Atkins, MBBS

  University of East Anglia

  PRINCIPAL INVESTIGATOR

• Ashnish Sinha

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 15, 2015
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 1, 2016

Record last verified: 2016-06

Locations

GB (1)