Asthma Clinical Trial - Relationship of Airway Microbiota, Endotype &

Status Recruiting

Clinical Trial Summary

Increasing evidence supports that the respiratory microbiota, including viral and bacterial microorganisms, play important roles in respiratory health and disease. Microbial patterns in airways may induce distinctive endotypes of asthma. Previous studies suggest host-microbiota interactions in children may account for the heterogeneity of endotypes and clinical presentations. However, information on such relationship is limited in adults. Furthermore, how the upper airway microbiome is related to asthma endotype and phenotype is not well understood. Knowledge of microbiota in the airway allows exploration of therapeutic manipulation of the microbiome and targeting the development of asthma prevention strategies and the optimization of asthma treatment.

Clinical Trial Description

This study plans to assess microbes in nasopharyngeal flock swab of asthma subjects. The swabs will be subjected to sequence analysis of 16S rRNA. Endotypes (e.g. TH1 vs TH2 inflammation) and phenotypes of the subjects (e.g. severity, exacerbation, lung function, etc.) will be assessed. The planned sample size is 140 adult asthma subjects. Patients will have nasopharyngeal swabs taken at baseline, 3 months (after optimization of asthma treatment at baseline) and at 1 year. They will undergo assessments, including clinical course, lung function, exhaled nitric oxide, skin test, and blood test (including eosinophils and immunoglobulin E levels). All subjects will be followed up for 2 years to assess subsequent exacerbations and levels of asthma control. The 16S data retrieved from the official website of HMP (http://www.hmpdacc.org/) will be used as the geographic reference for this study. Sequences assigned to different taxonomic levels, from phylum to genus using the RDP (ribosomal database project) database, will be clustered into operating taxonomic units (OTUs). Bioinformatic tools will be used to assess the relations of microbiota, asthma endotypes and phenotypes and change of microbiota pattern upon optimization of asthma drug treatment. ;

Study Design

Related Conditions & MeSH terms

Asthma

Clinical Trial Details

NCT number	NCT04706988
Study type	Observational
Source	Chinese University of Hong Kong
Contact	Fanny Ko, MD
Phone	+852 35053133
Email	fannyko@cuhk.edu.hk
Status	Recruiting
Phase
Start date	June 22, 2021
Completion date	December 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04624425` - Additional Effects of Segmental Breathing In Asthma	N/A
Terminated	`NCT04410523` - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma	Phase 2
Active, not recruiting	`NCT03927820` - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)	N/A
Completed	`NCT04617015` - Defining and Treating Depression-related Asthma	Early Phase 1
Recruiting	`NCT03694158` - Investigating Dupilumab's Effect in Asthma by Genotype	Phase 4
Terminated	`NCT04946318` - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma	Phase 2
Completed	`NCT04450108` - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients	N/A
Completed	`NCT03086460` - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)	Phase 2
Completed	`NCT01160224` - Oral GW766944 (Oral CCR3 Antagonist)	Phase 2
Completed	`NCT03186209` - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)	Phase 3
Completed	`NCT02502734` - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma	Phase 3
Completed	`NCT01715844` - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics	Phase 1
Terminated	`NCT04993443` - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036	Phase 1
Completed	`NCT02787863` - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology	Phase 4
Recruiting	`NCT06033833` - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study	Phase 2
Completed	`NCT03257995` - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.	Phase 2
Completed	`NCT02212483` - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients	N/A
Recruiting	`NCT04872309` - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn	`NCT01468805` - Childhood Asthma Reduction Study	N/A
Recruiting	`NCT05145894` - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms