Trial · NCT01952470
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Lung Clearance Index 2% (LCI2%) | 1 month, 3 months | A measure of ventilation inhomogeneity as measured during multiple breath washout (MBW) of inert tracer gases. It has been shown that this test is a potentially more sensitive measure of peripheral airway obstruction than regular spirometry in short term (4 week) mucolytic interventional studies in pediatric Cystic Fibrosis (CF)(17-18). This test would be performed within the respiratory physiology lung function laboratory on site at all assessment points, by an assessor who is blinded to group allocation for follow up data collection. Conventionally used primary endpoints in this population, such as regular spirometry(3), may be unable to detect between group differences without large sample sizes and long treatment durations. Based on current evidence from non-lung transplant populations, LCI has been able to show short-term change, whereas regular spirometry has not shown change(17-18). |
| Secondary | Multiple Breath Washout (MBW) | 1 month, 3 months | Multiple breath washout is a sensitive measure of respiratory function performed with the subject in a seated position, breathing a fixed tidal volume (1L) of inert gas (nitrogen) from functional residual capacity (FRC) via mouthpiece. Two common outcomes of MBW are Sacin, a measure of gas mixing at the diffusion front, or acinar entrance in the airways, and Scond, in the proximal, conductive zones. An increase in either Sacin or Scond represents an increase in ventilation heterogeneity (deterioration). Both increase with age, normal values are non-zero between 0-0.25(Sacin) and 0-0.1(Scond). |
| Secondary | Functional Residual Capacity (FRC) | 1 month, 3 months | Volume of air remaining in the lungs after normal expiration. |
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) Liters | 1 month, 3 months. | FEV1 is the maximal amount of air you can forcefully exhale in one second. |
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) Percent. | 1 month, 3 months | FEV1 is the maximal amount of air you can forcefully exhale in one second. |
| Secondary | Forced Vital Capacity (FVC) Liters | 1 month, 3 months | Forced vital Capacity (FVC) is a measure of the amount of air someone can forcibly expel out of the lungs after taking a breath to fill the lungs as much as possible. |
| Secondary | Forced Vital Capacity (FVC) Percent | 1 month, 3 months | Forced vital Capacity (FVC) is a measure of the amount of air someone can forcibly expel out of the lungs after taking a breath to fill the lungs as much as possible. |
| Secondary | Forced Expiratory Ratio (FER) | 1 month, 3 months | FER represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC). |
| Secondary | Leicester Cough Questionnaire (LCQ) - Change | 1 month, 3 months. | Cough specific quality of life questionnaire. The LCQ is a 19-question tool, validated in chronic lung disease other than lung transplant(19). Scale 1-7 for physical, psychological, social. Combined score of 3-21 for total. Lower=worse. |
| Secondary | St. George's Respiratory Questionnaire (SGRQ) - Change | 1 month, 3 months. | The SGRQ is a 2-part questionnaire, validated in chronic lung disease other than lung transplant(20). 50 items, 76 weighted responses. Scores range 0-100, higher=worse. |
| Secondary | Inpatient Days | Across study period (3 months). | Number of days spent in the acute inpatient setting. |
| Secondary | Oral, Inhaled or Intravenous Antibiotic (IVAB) Days. | Over study period (3 months). | Antibiotic use for the treatment of lower respiratory tract infections (LRTI) only. |
| Secondary | Number of Hospitalizations | Over study period (3 months). | Number of admissions to the acute setting. |
| Secondary | C-reactive Protein (CRP) | 1 month, 3 months. | An inflammatory marker measured with routine blood tests on admission with LRTI. Taken during inpatient (IP) stay and routinely on outpatient (OP) follow-up. Existing / available data only will be used - no extra routine bloods will be taken on account of study inclusion. |
| Secondary | Breathlessness, Cough and Sputum Scale (BCSS) - Exacerbations | Daily up to 3 months. | Self-reported symptom severity, used as a daily patient diary. The BCSS is a 12 point self-reported symptom severity score, consisting of 3 sections concerning how much difficulty the subject is having with breathing; subjective cough symptoms and trouble caused by sputum, each scoring between 0-4, combining to a total score of 0-12 (higher=worse). This scale is validated for daily use in Chronic Obstructive Pulmonary Disease (COPD)(21). An exacerbation was defined as an increase in BCSS\>1 with ≥5 days preceding stability. |
| Secondary | BronkoTest (Sputum Colour) - Purulent Sputum Days | Daily up to 3 months. | Sputum colour chart. Sputum colour has been shown to correlate with physiological infection in other chronic lung disease groups(22). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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