Oral roflumilast 250 microgram daily will be started at the baseline visit for 4 weeks. For those who can tolerate the initial 4-week treatment, roflumilast will be increased to 500 microgram daily, allowing subsequent dose reduction back to 250 microgram daily in case of CTCAE grade 3 or 4 toxicities.

Non-cystic Fibrosis Bronchiectasis

Roflumilast, a phosphodiesterase 4 (PDE4) inhibitor is approved worldwide (including Hong Kong) for treatment of severe chronic obstructive pulmonary disease (COPD) with frequent exacerbations. Roflumilast has been shown to have anti-inflammatory effect in patients with COPD, with significant reduction of sputum absolute neutrophil count, IL-8 and neutrophil elastase compared with placebo treatment. Roflumilast can also improve the lung function parameters in patients with COPD and reduce the rate of moderate-to-severe exacerbations.

Roflumilast Oral Tablet

Queen Mary Hospital

Roflumilast in Non-CF Bronchiectasis Study (2019)

Anti-inflammatory Effects of Roflumilast Treatment for 12 Weeks in Stable-state Non-cystic Fibrosis Bronchiectasis

Daily sputum volume is determined as the average of a three consecutive day collection (9:00 a.m. to 9:00 a.m.) at home, using clear pre-labeled sterile plastic (60 ml) pots stored at 4°C. Subjects are instructed and trained to completely empty the contents of their mouth before expectorating into the sputum pots to ensure minimal contamination by saliva and food debris. The volume of a 24-hour sputum specimen is determined as the volume of water (to the nearest 0.1 ml) in an adjacent identical pot containing water at the same level as the sputum in the sputum-containing pot.

A fresh sputum sample is collected in a sterile clear plastic pot after thorough mouth emptying on the day of planned clinic visit. Sputum leukocyte density is measured within 2 hours of collection by a designated technician, based on five aliquots chosen randomly from the center of a fresh specimen, which are then serially diluted with phosphate-buffered saline (PBS) and read with a light microscope and a hemocytometer as we previously described.

Fresh sputum sample is stored at −70° C within 15 min of collection until ultracentrifugation (100,000 g for 30 min at 4° C) to obtain the sol phase used for enzyme-linked immunoabsorbent assay of cytokines (IL-1β, IL-8, TNF-alpha, IL-17) and LTB4 levels using commercially available kits.

Sputum neutrophil elastatse is measured using a commercially available kinetic, chromogenic microtitre plate assay with succinyl-Ala-Ala-Pro-Val-p-nitroanalide (Bachem) as a substrate, as we previously described. A standard curve, constructed from known concentrations of purified elastase, is included in each assay.

Sputum for bacterial culture is saved and sputum bacterial load is measured at designated visits as described previously with modifications.

Patients' HRQoL will be measured by St. George's Respiratory Questionnaire Hong Kong Chinese version (SGRQ-HK). SGRQ-HK is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airway disease. It consists of 2 parts with 50 items. It addresses frequency and severity patients' symptoms, as well as activities that cause or are limited by breathlessness. The scores range from 0 to 100, with higher scores indicating more limitations. The minimally important difference is a mean change of 4 units for slightly efficacious treatment, 8 units for moderately efficacious change and 12 units for very efficacious treatment. SGRQ-HK has been validated in patients with bronchiectasis and is considered a valid and sensitive instrument for determining quality of life in bronchiectasis patients.

James Chung-Man HO

Clinical Associate Professor

The University of Hong Kong

Inflammatory Bowel Diseases

PCR-Restriction fragment length polymorphism

PCR-RFLP

Lymphoid Tyrosine Phosphatase Gene Polymorphisms in Inflammatory Bowel Disease

Three single nucleotide polymorphisms in the lymphoid tyrosine phosphatase gene(SNP (G788>A) in exon10, SNP (C1858>T) in exon 14 and SNP (G -1123>C) in the promoter region ) will be assessed in 100 patients diagnosed as inflammatory bowel disease and 100 healthy subjects by Polymerase Chain Reaction-Restriction Fragment Length Polymorphism (PCR-RFLP) to detect association between these polymorphisms and inflammatory bowel disease

Serum Erythrocyte Sedimentation Rate ,C-Reactive Protien ,Anti Nuclear Antibody ,Antineutrophil Cytoplasmic Antibody (ANCA) and Anti Saccharomyces Cerevisiae (ASCA) and fecal calprotectin will be done to all patients.The three investigated polymorphisms in LYP will be correlated with the markers of disease activity and IBD patients response to therapy.

Mennat-Allah Refaat Ali

doctor

Assiut University

Psyllium powder is used as the placebo. A member of the research staff will package and dispense L-alanine and placebo in similar containers. A standard measuring spoon will be provided to the subject for preparing the placebo solution. Subjects will mix the placebo in the beverage of their choice and consume this approximately 20 minutes before meals or snacks, in according with the dosing guidelines set for them by the dietitian.
Meal Placebo Breakfast * 1-2 scoops Snack * .5 - 1 scoop Lunch * 1-2 scoops Snack * .5 - 1 scoop Dinner * 1-2 scoops

L-alanine, USP (Spectrum® Chemicals and Laboratory Products, Gardena, CA) will be packaged and dispensed by one member of the research staff who will have no other role in the study. A one-month supply will be dispensed to the subjects.
Meal L-Alanine Breakfast * 1-2 scoops Snack * .5 - 1 scoop Lunch * 1-2 scoops Snack * .5 - 1 scoop Dinner * 1-2 scoops

Fructose Intolerance

Subjects will mix the placebo in the beverage of their choice and consume this approximately 20 minutes before meals or snacks, in according with the dosing guidelines set for them by the dietitian.

Placedo

Subjects will mix the alanine in the beverage of their choice and consume this approximately 20 minutes before meals or snacks, in according with the dosing guidelines set for them by the dietitian.

Alanine

Augusta University

Investigation of Supplemental L-alanine in the Management of Dietary Fructose Intolerance

Investigation of Supplemental L-alanine in the Management of Dietary Fructose Intolerance: a Double-blind, Randomized Study

Change in GI symptom score with alanine and placebo, when compared to the baseline

Estimated daily consumption of fructose during the alanine and placebo phases, when compared to the baseline using prospective food diaries

Changes in breath hydrogen and/or methane values with alanine and placebo when compared with to the baseline

Changes in SF-12 scores between and after baseline and placebo

proline/proljev

Roflumilast in Non-CF Bronchiectasis Study (2019)

Lymphoid Tyrosine Phosphatase Gene Polymorphisms in Inflammatory Bowel Disease

Investigation of Supplemental L-alanine in the Management of Dietary Fructose Intolerance

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