N/A
N=126
The Natural History of Small Airways Physiology in Diseased and Healthy States
Asthma · COPD · Interstitial Lung Disease · Cystic Fibrosis · Patients Requiring Lung Transplant
Bottom Line
View on ClinicalTrials.gov: NCT00677560 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: FEV1 — 3.03; 2.32; 3.18; 2.76 L
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FEV1 |
3.03; 2.32; 3.18; 2.76; 1.67 | — |
| SECONDARY Calv |
4.3; 3.8; 2.9; 4.6; 3.7 | — |
| SECONDARY AX |
1.03; 1.88; 0.55; 0.82; 2.48 | — |
| SECONDARY R5 EX |
0.50; 0.60; 0.45; 0.50; 0.66 | — |
| SECONDARY J'aw |
138.5; 77.2; 76.2; 35.4; 60.7 | — |
| SECONDARY Sacin |
0.122; 0.214; 0.089; 0.150; 0.346 | — |
| SECONDARY Scond |
0.041; 0.068; 0.045; 0.057; 0.057 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00677560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.