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Report for D003550: Cystic Fibrosis NIH
(Synonyms: Cystic F, Cystic Fi, Cystic Fibros, Cystic Fibrosi, Cystic Fibrosis)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (8)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug845 | Mupirocin Wiki | 0.71 |
| drug490 | Exercise Wiki | 0.71 |
| drug1422 | Trimethoprim Sulfamethoxazole (TMP/SMX) Wiki | 0.71 |
| drug833 | Minocycline Wiki | 0.71 |
| drug307 | Chlorhexidine Gluconate Wiki | 0.71 |
| drug1448 | Unsupervised exercise Wiki | 0.71 |
| drug481 | Environmental Decontamination Wiki | 0.71 |
| drug234 | CFTR Modulators Wiki | 0.71 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 2 clinical trials
Clinical Trials
1 STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)
To evaluate the micro-biologic efficacy and safety of a streamlined treatment for early onset methicillin-resistant staphylococcus aureus (MRSA) in patients with cystic fibrosis.
NCT03489629 Cystic Fibrosis Drug: Trimethoprim Sulfamethoxazole (TMP/SMX) Drug: Minocycline Drug: Mupirocin Drug: Chlorhexidine Gluconate Behavioral: Environmental Decontamination MeSH:Cystic Fibrosis
Primary Outcomes
Description: Descriptive summary with corresponding 95% confidence interval.
Measure: Proportion of STAR-TER subjects with a negative MRSA culture at Day 28 vs. observational arm of historic STAR-Too trial Time: Day 28Secondary Outcomes
Description: Pulmonary exacerbation is defined as having 1 of the major criteria or 2 minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Measure: Proportion of subjects with a protocol-defined pulmonary exacerbation between Baseline and Day 28 treated with antibiotics active against MRSA Time: Period ranging from start of Baseline and continuing through Day 28Description: Pulmonary exacerbation is defined as having 1 of the major criteria or 2 of the minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Measure: Proportion of subjects with a protocol-defined pulmonary exacerbation between Baseline and Day 28 treated with any oral, inhaled, or IV antibiotics regardless of potential activity against MRSA Time: Period ranging from start of Baseline and continuing through Day 28Measure: Proportion of subjects treated with oral, inhaled, and IV antibiotics over the six-month study Time: Period ranging from start of Baseline and continuing through Month 6
Description: Pulmonary exacerbation is defined as having 1 of the major criteria or 2 of the minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Measure: Time to protocol-defined pulmonary exacerbation over the six-month study Time: Period ranging from start of Baseline and continuing through Month 6Description: Pulmonary exacerbation is defined as having 1 of the major criteria or 2 of the minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Measure: Number of protocol-defined pulmonary exacerbations over the six-month study Time: Period ranging from start of Baseline and continuing through Month 6Description: Proportion of subjects with a negative culture for MRSA at Day 56
Measure: MRSA Culture Status Time: Day 56Description: Compliance refers to the amount of prescribed medication consumed.
Measure: Proportion of subjects with >80% compliance for study drug during the first 28 days Time: Day 282 Combined Effect of CFTR Protein Modulator Drugs and Exercise on Pulmonary Function, Fitness, Sweat Test and Quality of Life in Children With Cystic Fibrosis
This study aims to assess the effects of programmed exercise combined with CFTR protein modulator drugs in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis.
NCT04415268 Cystic Fibrosis in Children Behavioral: Exercise Behavioral: Unsupervised exercise Drug: CFTR Modulators MeSH:Cystic Fibrosis Fibrosis
Primary Outcomes
Description: Changes in strength will be measured using a five repetition maximum test (5RM)
Measure: Change in Strength Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in cardiorespiratory fitness will be measured using a cardiopulmonary exercise test (CPET)
Measure: Change in Cardiorespiratory Fitness Time: Four assessment points throughout the study: baseline and after each 8-week interventionSecondary Outcomes
Description: Changes in FEV1 will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in Forced expiratory volume in 1 second (FEV1) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in FVC will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in Forced vital capacity (FVC) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in FEV1/FVC ratio (FEV1%) will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in FEV1/FVC ratio (FEV1%) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in FEF will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in Forced expiratory flow (FEF) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in physical activity levels will be measured using PAQ-C for children under 14 years of age and PAQ-A for adolescents over 14 years of age. Items 1 to 9 will be used in the physical activity composite score, and means will be calculated to obtain the final PAQ-C activity summary score. Items 1 to 8 will be used in the physical activity composite score, and means will be calculated to obtain the final PAQ-A activity summary score. A score of 1 indicates low physical activity, whereas a score of 5 indicates high physical activity.
Measure: Changes in Physical Activity Questionnaire (PAQ) for children and adolescents Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in quality of life will be measures with the Cystic Fibrosis-Questionnaire-Revised (CFQ-R). Scores for each health related quality of life domain are calculated; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health.
Measure: Change in quality of life: Cystic Fibrosis-Questionnaire-Revised (CFQ-R) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Chloride concentration in sweat (mEq/L) will be measured in the laboratory using an MK II Chloride Analyzer 926S
Measure: Sweat chloride level Time: Four assessment points throughout the study: baseline and after each 8-week intervention