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NCT Number: NCT00677560

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

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.

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Key information

Conditions

Asthma Bronchial Diseases COPD Chronic Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Disease Attributes Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infant, Newborn, Diseases Inflammation Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Lung Diseases, Obstructive Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Patients Requiring Lung Transplant Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Aspiration Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

London, SW3 6LY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. FEV1

    Time frame: 120 minutes

    Forced expiratory volume in one second

Secondary outcomes

  1. Calv

    Time frame: 120 minutes

    Nitric oxide arising from the alveolar compartment.

  2. AX

    Time frame: 120 minutes

    Reactance area for whole-breath

  3. R5 EX

    Time frame: 120 minutes

    Resistance measured at 5 hertz during expiration

  4. J'aw

    Time frame: 120 minutes

    Bronchial nitric oxide flux

  5. Sacin

    Time frame: 120 minutes

    Ventilation heterogeneity within the acinar airways

  6. Scond

    Time frame: 120 minutes

    Ventilation heterogeneity within the conducting airways

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 14, 2008
Registry last updated
Dec 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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