The Natural History of Small Airways Physiology in Diseased and Healthy States

NCT00677560 | Completed Results DMC

• 1 other identifier: 08/H0709/2
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Spirometry is a useful clinical tool for the assessment and monitoring of lung disease, however, it does not provide information on peripheral airways resistance. On the contrary, impulse oscillometry (IOS) may provide information not only on airway resistance (Rrs) but also on the elastic properties of the lung (Xrs). In addition, multiple breath nitrogen washout (MBNW) utilizes the exhalation of nitrogen gas from the airways to determine changes in lung ventilation and derive small airways indices (that tells us about small airways calibre). This method, like IOS, allows a precise assessment of small airways function. Even though patients with asthma may show some reduction of the caliber of the small airways these changes are more a feature of patients with COPD. The study team hypothesize that IOS and MBNW measurements may detect these differences and provide different resistance profiles for asthma and COPD. Furthermore, the study team would like to investigate the relationship between airway inflammation and small airway disease by measuring exhaled nitric oxide (NO) at multiple exhalation flow rates. This technique allows the partitioning of NO produced in the central airways from that generated more peripherally in the lung, providing valuable information on the activity of inflammation in different parts of the respiratory system. The study team hope that the combined use of IOS, MBNW and NO will identify a possible correlation between inflammation and small airway dysfunction.

Conditions

Asthma; COPD; Interstitial Lung Disease; Cystic Fibrosis; Patients Requiring Lung Transplant

Keywords

resistance; reactance; inflammation; lung function; respiratory function

Outcome Measures

Primary Outcomes (1)

• FEV1

  Forced expiratory volume in one second

  120 minutes

Secondary Outcomes (6)

• Calv

  120 minutes

• AX

  120 minutes

• R5 EX

  120 minutes

• J'aw

  120 minutes

• Sacin

  120 minutes

Study Arms (5)

3

Mild-moderate asthma. Within the asthma group, there were two sub-groups; mild-moderate asthma and severe asthma distinguished using the Global Initiative for Asthma (GINA) guidelines (GINA, 2009).

4

Severe Asthma Within the asthma group, there were two sub-groups; mild-moderate asthma and severe asthma distinguished using the Global Initiative for Asthma (GINA) guidelines (GINA, 2009).

1

Normal subjects Normal subjects were a group made up of healthy subjects, with normal lung function, non-smokers at the time of the screening.

2

Healthy smokers Healthy smokers were comprised of people who were current smokers and had normal lung function at the time of screening.

5

COPD (Gold stage I - III) The COPD group included stage I to III patients, classified according to severity of airflow limitation (post bronchodilator FEV1), from the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (GOLD, 2011).

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients will be recruited from outpatient clinics

You may qualify if:

• male or female, aged between 18-85 years;
• volunteers who are able to give written informed consent Patients meeting the diagnostic criteria for asthma, COPD, ILD, CF, chronic cough.

You may not qualify if:

• upper respiratory tract infection within the previous 28 days
• any history or evidence of renal, cardiovascular, gastrointestinal or hepatic disease
• any history and evidence of neuropsychiatric disease
• treatment with antibiotics within 4 weeks prior to the study
• alcohol, drug abuse or any other condition associated with poor compliance
• breast feeding
• pregnancy
• are unable to provide written informed consent

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Airway Disease Section, National Heart and Lung Institute, Imperial College

London, SW3 6LY, United Kingdom

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial; Cystic Fibrosis; Inflammation; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Respiration Disorders

Results Point of Contact

• Title: Dr Harpal Singh Kalsi
• Organization: Queen Mary University of London

h.kalsi@qmul.ac.uk

07872492181

Study Officials

• Paolo Paredi, MD, PhD

  Airway Disease Section, National Heart and Lung Institute, Imperial College, London

  STUDY DIRECTOR

• Omar A Usmani, MD, PhD

  Airway Disease Section, National Heart and Lung Institute, Imperial College, London

  PRINCIPAL INVESTIGATOR

• Peter J Barnes, Prof

  Airway Disease Section, National Heart and Lung Institute, Imperial College, London

  STUDY CHAIR

• Neil Pride, Prof

  Airway Disease Section, National Heart and Lung Institute, Imperial College, London

  STUDY CHAIR

• Michael Goldman, Prof

  Airway Disease Section, National Heart and Lung Institute, Imperial College, London

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 12, 2008
• First Posted: May 14, 2008
• Study Start: June 22, 2010
• Primary Completion: July 10, 2013
• Study Completion: July 10, 2013
• Last Updated: December 20, 2021
• Results First Posted: December 20, 2021

Record last verified: 2021-11

Locations

GB (1)