Trial · NCT03623698
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Antibiotic Courses | Change from baseline (before treatment) and 12 months after treatment | Treatments due to respiratory exacerbations |
| Primary | Number of Hospitalsations Due to Respiratory Exacerbations | Change from baseline (before treatment) and 12 months after treatment | Number of respiratory exacerbations that required not planned hospitalisation |
| Secondary | Participant's Perception of Treatment | At 12 months after starting treatment with hypertonic saline | Questionnaire: "Hypertonic saline treatment questionnaire". Perception of overall usefulness of nebulised hypertonic saline: "Useful", "Not useful", "I don't know". |
| Secondary | Parent's or Legal Guardian's Perception of Treatment | At 12 months after starting treatment with hypertonic saline | "Hypertonic saline treatment questionnaire for legal guardian". Measures the perception of overall usefulness of nebulised hypertonic saline through a likert scale: Very useful, useful, neither useful or not useful, not useful, not at all useful. |
| Secondary | Score on the Ease of Airway Clearance Pictorial Analogue Scale From Children and Young Adults as Participants | Change from baseline (before treatment) and 12 months after treatment | Pictorial visual scale "Facial Rating of perceived exertion Scale". Measures ease of airway clearance. Values range starting in 0 (Extremely easy) to 10 (Extremely hard), including 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10. Numbers are also associated with facial expressions. |
| Secondary | Score on the Ease of Airway Clearance From Parents or Legal Guardians | Change from baseline (before treatment) and 12 months after treatment | Measures ease of airway clearance through a 1-5 likert scale: 1) Very easy, 2) Easy, 3) Neither easy nor difficult, 4) Not easy, 5) Not at all easy. |
| Secondary | Apnea Index (AI) | Change from baseline (before treatment) and 12 months after treatment | The number of apneas recorded during the study per hour of sleep |
| Secondary | AHI | Change from baseline (before treatment) and 12 months after treatment | Nocturnal Apnoea Hipopnea index: total number of apnea events plus hypopnea events divided by the total number of minutes of actual sleep time and then multiplied by 60. |
| Secondary | %SpO2 | Change from baseline (before treatment) and 12 months after treatment | Nocturnal oxygen saturation |
| Secondary | Nocturnal ODI | Change from baseline (before treatment) and 12 months after treatment | Oxygen desaturation index: Number of desaturations per hour of sleep |
| Secondary | TcPCO2 | Change from baseline (before treatment) and 12 months after treatment | Nocturnal Transcutaneous Carbon Dioxide in kPa |
| Secondary | FEV1/FVC %Predicted Rate of Decline | Change from baseline (before treatment) and 12 months after treatment | Rate of decline per year of Tiffenau index |
| Secondary | FEV1% Predicted Rate of Decline | Change from the baseline (before treatment) and 12 months after treatment | Rate of decline of Forced Expiratory Volume in first second (FEV1) percentage of predicted. Rate of decline is a measure of slope of FEV1 percentage predicted. Baseline slope: \[(FEV1% at baseline / FEV1% 12 months before treatment) - 1\] \* 100 After treatment slope: \[(FEV1% 12 months after treatment / FEV1% at baseline) - 1\] \* 100 |
| Secondary | FVC% Predicted Rate of Decline | Change from baseline (before treatment) and 12 months after treatment | Rate of decline of Forced Vital Capacity (FVC) percentage of predicted. Rate of decline is a measure of slope of FVC%. Baseline slope: \[(FVC% at baseline / FVC% 12 months before treatment) - 1\] \* 100 After treatment slope: \[(FVC% 12 months after treatment / FVC% at baseline) - 1\] \* 100 |
| Secondary | Peak Expiratory Flow (PEF) | Change from baseline peak expiratory flow at 12 months after starting treatment with hypertonic saline | Peak expiratory flow percentage of predicted |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03623698/registered