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D003550: Cystic Fibrosis

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (18)


Name (Synonyms) Correlation
drug1208 Environmental Decontamination Wiki 0.45
drug4129 supportive and symptomatic treatment Wiki 0.45
drug3930 intravenous immunoglobulin therapy Wiki 0.45
Name (Synonyms) Correlation
drug610 COM-COVID anonimous survey Wiki 0.45
drug3914 hypoxia : 14.3 and 12.7% FIO2, hypercapnia 7% CO2, inspiratory mechanical constraint Wiki 0.45
drug775 Chlorhexidine Gluconate Wiki 0.45
drug3924 inhalable hydroxychloroquine (HCQ) Wiki 0.45
drug3589 Unsupervised exercise Wiki 0.45
drug3919 imaging, blood tests Wiki 0.45
drug3538 Trimethoprim Sulfamethoxazole (TMP/SMX) Wiki 0.45
drug2066 Minocycline Wiki 0.45
drug595 CFTR Modulators Wiki 0.45
drug3432 Tezacaftor/Ivacaftor + Ivacaftor Wiki 0.45
drug2105 Mupirocin Wiki 0.45
drug1232 Exercise Wiki 0.26
drug1713 Interview Wiki 0.26
drug2741 Questionnaire Wiki 0.08
drug2557 Placebo oral tablet Wiki 0.08

Correlated MeSH Terms (7)


Name (Synonyms) Correlation
D005355 Fibrosis NIH 0.50
D055732 Pulmonary Aspergillosis NIH 0.45
D001228 Aspergillosis NIH 0.45
Name (Synonyms) Correlation
D001229 Aspergillosis, Allergic Bronchopulmonary NIH 0.45
D009181 Mycoses NIH 0.32
D003141 Communicable Diseases NIH 0.03
D007239 Infection NIH 0.02

Correlated HPO Terms (0)


Name (Synonyms) Correlation

Clinical Trials

Navigate: Correlations   HPO

There are 5 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
Conditions
  1. Cystic Fibrosis
Interventions
  1. Drug: Trimethoprim Sulfamethoxazole (TMP/SMX)
  2. Drug: Minocycline
  3. Drug: Mupirocin
  4. Drug: Chlorhexidine Gluconate
  5. 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 28

Secondary 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 28

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: 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 28

Measure: 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 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: Number of protocol-defined pulmonary exacerbations over the six-month study

Time: Period ranging from start of Baseline and continuing through Month 6

Description: Proportion of subjects with a negative culture for MRSA at Day 56

Measure: MRSA Culture Status

Time: Day 56

Description: 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 28
2 A Randomised Crossover Pilot Study of the Effects of Tezacaftor/Ivacaftor and Ivacaftor on Gastrointestinal Function Using Magnetic Resonance Imaging Parameters in People With Cystic Fibrosis

People with Cystic Fibrosis (CF) have problems digesting their food properly. More than 8 in 10 people with CF must take medication to assist their digestion. In spite of this, complications such as bowel blockage occur. Finding out how already licenced drugs for CF work in the gut is the first step in repurposing medications. Tezacaftor/Ivacaftor with Ivacaftor is a drug combination which corrects the basic defect in CF an has shown improvements on lung function. The purpose of this study is to evaluate, using Magnetic Resonance Imaging (MRI) and patient-reported outcomes, whether Tezacaftor/Ivacaftor with Ivacaftor has an effect on improving gastrointestinal problems in CF.

NCT04006873
Conditions
  1. Cystic Fibrosis
Interventions
  1. Drug: Tezacaftor/Ivacaftor + Ivacaftor
  2. Drug: Placebo oral tablet
MeSH:Cystic Fibrosis Fibrosis

Primary Outcomes

Description: Time taken after eating for ingested food to be identifiable at the caecum on MRI

Measure: Oro-caecal Transit Time

Time: 1 day of scanning

Secondary Outcomes

Description: Volume of stomach at each time point of digestion to measure gastric emptying time

Measure: Gastric volume

Time: 1 day of scanning

Description: Volume of water content in small bowel representing secretions and post prandial change in small bowel water content at T240 and T300

Measure: Small bowel water content (corrected for body surface area)

Time: 1 day of scanning

Description: Volume of colon representing ease of chyme passage through colon

Measure: Colonic volume (corrected for body surface area)

Time: 1 day of scanning

Description: Gastrointestinal symptoms measured by patient reported outcomes to monitor relationships with outcomes measure by MRI

Measure: Gastrointestinal symptoms

Time: 1 day of scanning

Other Outcomes

Description: Volume of sigmoid colon

Measure: Sigmoid colon volume

Time: 1 day of scanning

Description: An approximate measure of water content in chyme present in the ascending colon

Measure: T1 relaxation of ascending colon chyme

Time: 1 day of scanning

Description: A measure of fat content in chyme present in the ascending colon

Measure: Fat fraction of ascending colon chyme

Time: 1 day of scanning

Description: A measure of elastase in stool to evaluate pancreatic function

Measure: Faecal elastase

Time: 1 day

Description: A measure of microbiome in sputum and stool

Measure: Sputum and faecal microbiome

Time: 1 day

Description: A measure of intestinal inflammation

Measure: Faecal calprotectin

Time: 1 day

Description: A measure of motility at the terminal ileum using the GIQuant tool in arbitrary units

Measure: Terminal Ileum motility

Time: 1 day
3 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
Conditions
  1. Cystic Fibrosis in Children
Interventions
  1. Behavioral: Exercise
  2. Behavioral: Unsupervised exercise
  3. 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 intervention

Description: 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 intervention

Secondary 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 intervention

Description: 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 intervention

Description: 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 intervention

Description: 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 intervention

Description: 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 intervention

Description: 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 intervention

Description: 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
4 Impacts of the Covid-19 Epidemic and Associated Lockdown Measures on the Management, Health and Behaviors of Cystic Fibrosis Patients During the 2020 Epidemic

Impacts of the Covid-19 epidemic and associated lockdown measures on the management, health and behaviors of cystic fibrosis patients during the 2020 epidemic

NCT04463628
Conditions
  1. Cystic Fibrosis in Children
  2. Cystic Fibrosis
Interventions
  1. Behavioral: Questionnaire
  2. Behavioral: Interview
MeSH:Cystic Fibrosis Fibrosis

Primary Outcomes

Description: Number of consultations cancelled or postponed by the health professional or patient of consultations (medical and paramedical),

Measure: Cancellation or postponement of consultations by the health professional or patient,

Time: Up to 6 months

Description: Number of consultations cancelled by the teleconsultation/replacement patient,

Measure: Patient cancellation of teleconsultations/telecare replacement,

Time: Up to 6 months

Description: Number of consultations cancelled or postponed by the health care institution or by the patient of hospitalizations (acute or scheduled)

Measure: Cancellation or postponement by the health care institution or by the patient of hospitalizations (scheduled or unscheduled),

Time: Up to 6 months

Description: Number of patients affected by the change in the modality of administration of antibiotic cures (intravenous instead of intravenous administration).

Measure: Change in the modalities of administration of antibiotics cures (oral instead of intravenous administration).

Time: Up to 6 months

Secondary Outcomes

Description: Cancellation or postponement by the patient of consultations (medical or paramedical) Patient cancellation of teleconsultations/telecare proposed by the health professional Cancellation or postponement by the patient of hospitalizations (acute or scheduled)

Measure: The reduction of each of the elements of care provision and health care utilization:

Time: Up to 6 months

Description: Intravenous instead of intravenous administration

Measure: The change of modality of administration of antibiotic cures

Time: Up to 6 months

Description: Questionnaire about taking or not taking treatment during confinement

Measure: Compliance

Time: Up to 6 months

Description: Scale 0-21

Measure: Anxiety and stress (at risk of being affected by COVID-19 or at risk of being treated less well)

Time: Up to 6 months

Description: A questionnaire on the presence or absence of toxic consumption

Measure: Presence or absence of toxic consumption (drug, alcohol) during the lockdown

Time: Up to 6 months

Description: Experience and social representations of confinement by cystic fibrosis patients (evaluated by qualitative methods)

Measure: Evaluation of the knowledge, experience and social representations of the risk of Covid-19

Time: Up to 6 months

Description: Role of social inequalities in the consequences of containment assessed by qualitative methods

Measure: Assessing the role of social inequalities in the consequences of lockdown

Time: Up to 6 months

Description: Prevalence of suspected and/or confirmed Covid-19 infections in patients with cystic fibrosis

Measure: Suspected and/or confirmed Covid-19 in patients with cystic fibrosis.

Time: Up to 6 months
5 Immune Profiles in CF Fungal Infection

This study is investigating the role of allergic (Th2) inflammation in patients with Cystic Fibrosis (CF) and history of fungal infection and/or Allergic Bronchopulmonary Aspergillosis. Little is known about fungal infection in CF and conflicting results exist on whether this results in worse lung function over time. There is concern that persistent fungal infection can result in worse clinical outcome measures in patients with CF. Also, it is unclear how ABPA develops, but may be related to the amount of fungus a patient with CF is infected with. This study looks at inflammatory patterns and allergic responses to fungal elements to help identify biomarkers and signs of allergic disease in fungally infected patients with CF.

NCT04476758
Conditions
  1. Cystic Fibrosis
  2. Fungal Infection
  3. Allergic Bronchopulmonary Aspergillosis
MeSH:Infection Communicable Diseases Mycoses Aspergillosis Pulmonary Aspergillosis Aspergillosis, Allergic Bronchopulmonary Cystic Fibrosis Fibrosis

Primary Outcomes

Description: Difference in sputum Th2 biomarkers (ECP, IL4, IL5, IL10, IL13, and eosinophil count) in patients with CF with fungal infection with expected elevation of sputum Th2 biomarkers in patients with CF and ABPA compared to those without fungal infection and without ABPA.

Measure: Difference in Th2 Sputum Markers

Time: Average of 24 months

Secondary Outcomes

Description: Serum Th2 biomarkers in patients with fungal infection and ABPA (Table 3). Serum Th1 biomarkers in patients with fungal infection and ABPA (Table 3). Serum sensitization markers to fungal allergens in patients with fungal infection and ABPA (Table 4). Baseline and historic lung function, historical comorbid diagnoses and BMI measurements in patients with fungal infection and ABPA. Environmental factors that are possibly related to fungal infection and ABPA in patients with CF. Immune profile: A profile of each group will be based upon their findings of each set of biomarkers: Th1, Th2, mold allergy panel, and systemic markers of inflammation. Based upon findings in each of these categories (elevated, depressed), we will be able to formulate a profile based upon the type of marker/inflammatory pathway.

Measure: Other markers of fungal inflammation and allergic reaction in patients with CF

Time: Average of 24 months

Other Outcomes

Description: Banking of both sputum and serum to potentially utilize microbiome and transcriptome techniques for further immunotyping and infection characterization.

Measure: Biobanking of specimens

Time: Average of 24 months

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

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