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

Asthma Clinical Trial

Official title:

Impulse Oscillometry and Airway Inflammation in Asthma and Chronic Obstructive Pulmonary Disease and Airways Physiology in Other Lung Conditions and Healthy Lungs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677560
• Other study ID #: 08/H0709/2
• Status: Completed
• Start date: June 22, 2010
• Est. completion date: July 10, 2013

Study information

• Verified date: November 2021
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Background The main objective of this study is to measure the damage of the small airways in lung disease exploring the "silent zone" with methods that have not been used before together in the same patients. Furthermore, because this is a 4 year longitudinal study, the study team will investigate the time related changes of small airway function in lung disease and normal healthy subjects. The study will also investigate the relationship between small airway resistance and inflammation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: July 10, 2013
• Est. primary completion date: July 10, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Asthma
• COPD
• Cystic Fibrosis
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Locations

Country	Name	City	State
United Kingdom	Airway Disease Section, National Heart and Lung Institute, Imperial College	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1	Forced expiratory volume in one second	120 minutes
Secondary	Calv	Nitric oxide arising from the alveolar compartment.	120 minutes
Secondary	AX	Reactance area for whole-breath	120 minutes
Secondary	R5 EX	Resistance measured at 5 hertz during expiration	120 minutes
Secondary	J'aw	Bronchial nitric oxide flux	120 minutes
Secondary	Sacin	Ventilation heterogeneity within the acinar airways	120 minutes
Secondary	Scond	Ventilation heterogeneity within the conducting airways	120 minutes