BronchiectasisPhase 4NCT04765033
Trial on The Efficacy of Hypertonic Saline on Non-CF CSLD.
A Phase 4 study testing Nebulized 5% Hypertonic saline in people with Bronchiectasis, run by University of Malaya at 1 site in Malaysia.
Trial summary
To determine the efficacy of nebulized 5% hypertonic saline on cough severity and quality of life, in children with non-CF CSLD. Secondary Aims: To determine the: 1. Efficacy of nebulized 5% hypertonic saline on airway microbiome, pulmonary exacerbation rate, healthcare utilization, and rescue antibiotics. 2. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Nebulized 5% Hypertonic saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteMalaysia
- Study dates
- 4 Feb 2021to 28 Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients < 18 years old
- Followed up in the paediatric respiratory clinic of UMMC with a diagnosis of CSLD
Who cannot join
- Incomplete data or refusal to participate
- Unwell and/or unable to stop HS and/or antibiotics of any preparation other than azithromycin ( EOD
- On supplementary oxygen/home ventilation
- Poorly controlled asthma (as in the GINA guidelines) or bronchoconstriction that precedes the use of hypertonic saline.
- Oral antibiotics for less than 4 weeks before randomization for medication.
- Fall in PEFR > 20% post 5% HS challenge test or a positive HS challenge test in young children, as mentioned below.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Centre
Kuala Lumpur, Lembah Pantai, 59100
About this study
Official title: Efficacy of Nebulised 5% Hypertonic Saline in Children With Chronic Suppurative Lung Disease
To determine the efficacy of nebulized 5% hypertonic saline on cough severity and quality of life, in children with non-CF CSLD.
Secondary Aims:
To determine the:
- Efficacy of nebulized 5% hypertonic saline on airway microbiome, pulmonary exacerbation rate, healthcare utilization, and rescue antibiotics.
- Efficacy of nebulized 5% hypertonic saline on lung function
- Adverse effects of nebulized 5% hypertonic saline in children
Read the detailed description
Primary Aim:
To determine the efficacy of nebulized 5% hypertonic saline on cough severity and quality of life, in children with non-CF CSLD.
Here the investigators will be using validated pediatric cough questionnaires to asses this. Patients will answer these questionnaires at first recruitment ( -1 mth), at randomization (0 month) and after 3 mths of use of the nebulized study drug (+ 3 mths)
Secondary Aims:
To determine the:
- Efficacy of nebulized 5% hypertonic saline on the airway microbiome, pulmonary exacerbation rate, healthcare utilization, and rescue antibiotics. Here the investigators will be taking history on the exacerbations, use of antibiotics and healthcare utilization before and after use of the hypertonic saline. Furthermore, Nasopharyngeal swabs will be done to review possible changes in microbiota, again before and after use of the 5% HS.
- Efficacy of nebulized 5% hypertonic saline on lung function. Here is investigators will be doing portable spirometry ( pre and post bronchodilator). Patients will perform at randomization (0 month) and after 3 mths of use of the nebulized study drug (+ 3 mths)
- Adverse effects of nebulized 5% hypertonic saline in children HS has been associated with side-effects. The investigators will monitor this. We will asses presence of these symptoms at randomization (0 month) and after 3 mths of use of the nebulized study drug (+ 3 mths) to ensure these are from the nebulizer.
- Conditions
- Bronchiectasis
- Being tested
- Nebulized 5% Hypertonic saline
- Keywords
- CSLD, Child, Nebuliser, Hypertonic Saline, Outcome, Chronic cough
- Medical subject headings
- Bronchiectasis, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized 5% Hypertonic salineDrug
Also called Placebo
nebulized 0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| 5% Hypertonic saline | Active comparator | 5% hypertonic saline nebuliser 4 mls twice in a day for 3 months Receives: Drug: Nebulized 5% Hypertonic saline |
| Placebo | Placebo comparator | 0.9% saline nebuliser 4 mls twice in a day for 3 months Receives: Drug: Nebulized 5% Hypertonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Short Parent-proxy cough quality of life (PC-QOL) score
Short PCQOL: This is a validated cough quality-of-life(QoL) questionnaire for parents of children with chronic cough, with a translated Malay version. Minimal Important Difference(MID) of 0.9 has been found in the validation study.
The answers are on a Likert scale from 1 (every time) to 7( none). A lower score denotes a lower quality of life.
The patients will answer either the English or the translated Malay version
Measured: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
Change in the Chronic Cough-specific QoL(CC-QOL) score
Chronic cough-specific QOL: This is a validated cough QoL questionnaire to be answered by children 7 years till 18 years old with a MID of about 1.1. The answers are in a Likert scale from 1 ( every time) to 7( none). A lower score denotes a lower quality of life.
The patients will answer either the English or the translated Malay version
Measured: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
Secondary outcomes (10)
Airway microbiome
DNA will be extracted from swabs using the Qiagen DNA Isolation Kit in accordance with the manufacturer's instructions. Bacterial profiling utilised the 16S rRNA gene targeting variable regions V3 - V4 will be carried out using Nextseq 2500 platform. Resulting raw fastq data will be processed using Dada2 R package and exported into phyloseq Rprogram for downstream analysis. The Alpha diversity will be measured using the Shannon and Simpson diversity indices while the beta diversity will be accessed using principle coordinate analysis and Permutational multivariate analysis of variance(PERMANOVA). Differentially abundant taxa will be identified by comparing the fold-change different using DESeq2.
Measured: At day 1 of randomization, at 3 months of use of study drug
Number of Exacerbations
Defined as having one major and 2 minor OR 2 major criteria irrespective of whether antibiotics are prescribed.
Criteria for exacerbation:
Major: (1) Wet cough over 72 hours, (2) Severe cough over 72 hours Minor: (1) Change in Sputum colour, (2) Chest pain, (3) SOB, (4) Haemoptysis, (5) + ve Chest signs
At -1 month, we will look at the no of exacerbations in the past 1 year. Before the use of the study drug and after 3 months of use of the study drug, we will look at the no of exacerbations in the preceding 1 month and 3 months, respectively.
Measured: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
Number of Unscheduled Health Care Visits
any unscheduled doctor visits for cough, shortness of breath or any other respiratory associated symptom.
This will be for the last 3 months before day 1 of randomization and after 3 months of use of study drug
Measured: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
No of episodes of rescue antibiotics
Prescription of antibiotics (including nebulized antibiotics) at least for 3 days for respiratory associated symptoms.
This will be in the past 3 months, before randomization and during the next 3 months, while on the study drug.
Measured: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
FEV1
FEV1 will be performed in sitting position(both pre and post 4 puffs of MDI Salbutamol) using the portable spirometry, performed in clinic. The best spirometric measure of at least 3 reproducible attempts will be recorded for analysis. Reference values from Morris/Polgar will be used with ethnic corrections. FEV1 value will be converted into z-score by using GrowingLungs software.
Measured: At day 1 of randomization, at 3 months of use of study drug
FVC
FVC will be performed in sitting position(both pre and post 4 puffs of MDI Salbutamol) using the portable spirometry, performed in clinic. The best spirometric measure of at least 3 reproducible attempts will be recorded for analysis. Reference values from Morris/Polgar will be used with ethnic corrections. FVC value will be converted into z-score by using GrowingLungs software.
Measured: At day 1 of randomization, at 3 months of use of study drug
FEF 25-75%
FEF 25-75% will be performed in sitting position(both pre and post 4 puffs of MDI Salbutamol) using the portable spirometry, performed in clinic. The best spirometric measure of at least 3 reproducible attempts will be recorded for analysis. Reference values from Morris/Polgar will be used with ethnic corrections. FEF25-75% value will be converted into z-score by using GrowingLungs software.
Measured: At day 1 of randomization, at 3 months of use of study drug
PEFR ( pre and post), if possible
The best PEFR measure out of 3 reproducible attempts ( both pre and post 4 puffs of MDI Salbutamol), performed when relatively well and stable, will be recorded for analysis.
Measured: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
Cough diary
The cough score will be assessed using the Malay version, used in the HOspitalised Pneumonia Extended study, whereby the cough score will be tabulated daily.
The cough diary has recordings for both day time cough: score 0 ( no cough) till score 5 ( Cannot perform most usual day-time activity due to severe coughing).
The night cough is scored score 0 ( no cough) till score 5 ( distressing cough.).
A higher score indicates more severe cough.
Measured: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
Number of Adverse events
cough, haemoptysis, sore throat, throat burning, chest tightness, hoarseness of voice.
Measured: At day 1 of randomization, at 3 months of use of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start4 Feb 2021
- Primary completion28 Aug 2023
- Study completion28 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind Placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Marie Nathan, University of Malaya
- Investigators
- Anna M Nathan, Principal investigator, UMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765033
- Sponsor's protocol ID
- 2020729-8926
- Status last verified
- Nov 2023
- First submitted
- 8 Feb 2021
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not to share
Publications
McCallum GB, Binks MJ. The Epidemiology of Chronic Suppurative Lung Disease and Bronchiectasis in Children and Adolescents. Front Pediatr. 2017 Feb 20;5:27. doi: 10.3389/fped.2017.00027. eCollection 2017.
PubMed 28265556Lovie-Toon YG, Grimwood K, Byrnes CA, Goyal V, Busch G, Masters IB, Marchant JM, Buntain H, O'Grady KF, Chang AB. Health-resource use and quality of life in children with bronchiectasis: a multi-center pilot cohort study. BMC Health Serv Res. 2019 Aug 13;19(1):561. doi: 10.1186/s12913-019-4414-5.
PubMed 31409413Chang AB, Bush A, Grimwood K. Bronchiectasis in children: diagnosis and treatment. Lancet. 2018 Sep 8;392(10150):866-879. doi: 10.1016/S0140-6736(18)31554-X.
PubMed 30215382Nathan AM, Muthusamy A, Thavagnanam S, Hashim A, de Bruyne J. Chronic suppurative lung disease in a developing country: impact on child and parent. Pediatr Pulmonol. 2014 May;49(5):435-40. doi: 10.1002/ppul.23001. Epub 2014 Jan 31.
PubMed 24482322Kumar A, Lodha R, Kumar P, Kabra SK. Non-cystic fibrosis bronchiectasis in children: clinical profile, etiology and outcome. Indian Pediatr. 2015 Jan;52(1):35-7. doi: 10.1007/s13312-015-0563-8.
PubMed 25638182Kapur N, Masters IB, Newcombe P, Chang AB. The burden of disease in pediatric non-cystic fibrosis bronchiectasis. Chest. 2012 Apr;141(4):1018-1024. doi: 10.1378/chest.11-0679. Epub 2011 Sep 1.
PubMed 21885727Gaillard EA, Carty H, Heaf D, Smyth RL. Reversible bronchial dilatation in children: comparison of serial high-resolution computer tomography scans of the lungs. Eur J Radiol. 2003 Sep;47(3):215-20. doi: 10.1016/s0720-048x(02)00122-5.
PubMed 12927665Cole PJ. Inflammation: a two-edged sword--the model of bronchiectasis. Eur J Respir Dis Suppl. 1986;147:6-15.
PubMed 3533593Hahn A, Warnken S, Perez-Losada M, Freishtat RJ, Crandall KA. Microbial diversity within the airway microbiome in chronic pediatric lung diseases. Infect Genet Evol. 2018 Sep;63:316-325. doi: 10.1016/j.meegid.2017.12.006. Epub 2017 Dec 7.
PubMed 29225146Zemanick ET, Harris JK, Wagner BD, Robertson CE, Sagel SD, Stevens MJ, Accurso FJ, Laguna TA. Inflammation and airway microbiota during cystic fibrosis pulmonary exacerbations. PLoS One. 2013 Apr 30;8(4):e62917. doi: 10.1371/journal.pone.0062917. Print 2013.
PubMed 23646159Cox MJ, Allgaier M, Taylor B, Baek MS, Huang YJ, Daly RA, Karaoz U, Andersen GL, Brown R, Fujimura KE, Wu B, Tran D, Koff J, Kleinhenz ME, Nielson D, Brodie EL, Lynch SV. Airway microbiota and pathogen abundance in age-stratified cystic fibrosis patients. PLoS One. 2010 Jun 23;5(6):e11044. doi: 10.1371/journal.pone.0011044.
PubMed 20585638Prentice BJ, Wales S, Doumit M, Owens L, Widger J. Children with bronchiectasis have poorer lung function than those with cystic fibrosis and do not receive the same standard of care. Pediatr Pulmonol. 2019 Dec;54(12):1921-1926. doi: 10.1002/ppul.24491. Epub 2019 Sep 1.
PubMed 31475469Chang AB. Bronchiectasis: so much yet to learn and to do. Paediatr Respir Rev. 2011 Jun;12(2):89-90. doi: 10.1016/j.prrv.2011.01.001. Epub 2011 Feb 2. No abstract available.
PubMed 21458735Tarran R, Grubb BR, Parsons D, Picher M, Hirsh AJ, Davis CW, Boucher RC. The CF salt controversy: in vivo observations and therapeutic approaches. Mol Cell. 2001 Jul;8(1):149-58. doi: 10.1016/s1097-2765(01)00286-6.
PubMed 11511368Kerem E, Reisman J, Corey M, Canny GJ, Levison H. Prediction of mortality in patients with cystic fibrosis. N Engl J Med. 1992 Apr 30;326(18):1187-91. doi: 10.1056/NEJM199204303261804.
PubMed 1285737
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nebulised 5% Hypertonic Saline in Children With Chronic Suppurative Lung Disease
- ClinicalTrials.gov ID
- NCT04765033
- Acronym / sponsor ID
- 2020729-8926
- Conditions
- Bronchiectasis
- Keywords
- CSLD, Child, Nebuliser, Hypertonic Saline, Outcome, Chronic cough
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the efficacy of nebulized 5% hypertonic saline on cough severity and quality of life, in children with non-CF CSLD.
Secondary Aims:
To determine the:
- Efficacy of nebulized 5% hypertonic saline on airway microbiome, pulmonary exacerbation rate, healthcare utilization, and rescue antibiotics.
- Efficacy of nebulized 5% hypertonic saline on lung function
- Adverse effects of nebulized 5% hypertonic saline in children
Detailed description
Primary Aim:
To determine the efficacy of nebulized 5% hypertonic saline on cough severity and quality of life, in children with non-CF CSLD.
Here the investigators will be using validated pediatric cough questionnaires to asses this. Patients will answer these questionnaires at first recruitment ( -1 mth), at randomization (0 month) and after 3 mths of use of the nebulized study drug (+ 3 mths)
Secondary Aims:
To determine the:
- Efficacy of nebulized 5% hypertonic saline on the airway microbiome, pulmonary exacerbation rate, healthcare utilization, and rescue antibiotics. Here the investigators will be taking history on the exacerbations, use of antibiotics and healthcare utilization before and after use of the hypertonic saline. Furthermore, Nasopharyngeal swabs will be done to review possible changes in microbiota, again before and after use of the 5% HS.
- Efficacy of nebulized 5% hypertonic saline on lung function. Here is investigators will be doing portable spirometry ( pre and post bronchodilator). Patients will perform at randomization (0 month) and after 3 mths of use of the nebulized study drug (+ 3 mths)
- Adverse effects of nebulized 5% hypertonic saline in children HS has been associated with side-effects. The investigators will monitor this. We will asses presence of these symptoms at randomization (0 month) and after 3 mths of use of the nebulized study drug (+ 3 mths) to ensure these are from the nebulizer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind Placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| 5% Hypertonic saline | Active comparator | Drug: Nebulized 5% Hypertonic saline5% hypertonic saline nebuliser 4 mls twice in a day for 3 months |
| Placebo | Placebo comparator | Drug: Nebulized 5% Hypertonic saline0.9% saline nebuliser 4 mls twice in a day for 3 months |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients < 18 years old
- Followed up in the paediatric respiratory clinic of UMMC with a diagnosis of CSLD
Key exclusion criteria (6 listed)
- Incomplete data or refusal to participate
- Unwell and/or unable to stop HS and/or antibiotics of any preparation other than azithromycin ( EOD
- On supplementary oxygen/home ventilation
- Poorly controlled asthma (as in the GINA guidelines) or bronchoconstriction that precedes the use of hypertonic saline.
- Oral antibiotics for less than 4 weeks before randomization for medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebulized 5% Hypertonic salineAlso: Placebonebulized 0.9% saline | Drug | 5% Hypertonic saline, Placebo |
Primary outcome
Change in the Short Parent-proxy cough quality of life (PC-QOL) score
Time frame: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
Short PCQOL: This is a validated cough quality-of-life(QoL) questionnaire for parents of children with chronic cough, with a translated Malay version. Minimal Important Difference(MID) of 0.9 has been found in the validation study. The answers are on a Likert scale from 1 (every time) to 7( none). A lower score denotes a lower quality of life. The patients will answer either the English or the translated Malay version
Change in the Chronic Cough-specific QoL(CC-QOL) score
Time frame: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
Chronic cough-specific QOL: This is a validated cough QoL questionnaire to be answered by children 7 years till 18 years old with a MID of about 1.1. The answers are in a Likert scale from 1 ( every time) to 7( none). A lower score denotes a lower quality of life. The patients will answer either the English or the translated Malay version
10 secondary outcomes
Airway microbiome
Time frame: At day 1 of randomization, at 3 months of use of study drug
Number of Exacerbations
Time frame: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
Number of Unscheduled Health Care Visits
Time frame: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
No of episodes of rescue antibiotics
Time frame: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
FEV1
Time frame: At day 1 of randomization, at 3 months of use of study drug
FVC
Time frame: At day 1 of randomization, at 3 months of use of study drug
FEF 25-75%
Time frame: At day 1 of randomization, at 3 months of use of study drug
PEFR ( pre and post), if possible
Time frame: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
Cough diary
Time frame: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
Number of Adverse events
Time frame: At day 1 of randomization, at 3 months of use of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Results publication: PubMed 28265556McCallum GB, Binks MJ. The Epidemiology of Chronic Suppurative Lung Disease and Bronchiectasis in Children and Adolescents. Front Pediatr. 2017 Feb 20;5:27. doi: 10.3389/fped.2017.00027. eCollection 2017.
- Results publication: PubMed 31409413Lovie-Toon YG, Grimwood K, Byrnes CA, Goyal V, Busch G, Masters IB, Marchant JM, Buntain H, O'Grady KF, Chang AB. Health-resource use and quality of life in children with bronchiectasis: a multi-center pilot cohort study. BMC Health Serv Res. 2019 Aug 13;19(1):561. doi: 10.1186/s12913-019-4414-5.
- Results publication: PubMed 30215382Chang AB, Bush A, Grimwood K. Bronchiectasis in children: diagnosis and treatment. Lancet. 2018 Sep 8;392(10150):866-879. doi: 10.1016/S0140-6736(18)31554-X.
- Results publication: PubMed 24482322Nathan AM, Muthusamy A, Thavagnanam S, Hashim A, de Bruyne J. Chronic suppurative lung disease in a developing country: impact on child and parent. Pediatr Pulmonol. 2014 May;49(5):435-40. doi: 10.1002/ppul.23001. Epub 2014 Jan 31.
- Results publication: PubMed 25638182Kumar A, Lodha R, Kumar P, Kabra SK. Non-cystic fibrosis bronchiectasis in children: clinical profile, etiology and outcome. Indian Pediatr. 2015 Jan;52(1):35-7. doi: 10.1007/s13312-015-0563-8.
- Results publication: PubMed 21885727Kapur N, Masters IB, Newcombe P, Chang AB. The burden of disease in pediatric non-cystic fibrosis bronchiectasis. Chest. 2012 Apr;141(4):1018-1024. doi: 10.1378/chest.11-0679. Epub 2011 Sep 1.
- Results publication: PubMed 12927665Gaillard EA, Carty H, Heaf D, Smyth RL. Reversible bronchial dilatation in children: comparison of serial high-resolution computer tomography scans of the lungs. Eur J Radiol. 2003 Sep;47(3):215-20. doi: 10.1016/s0720-048x(02)00122-5.
- Results publication: PubMed 3533593Cole PJ. Inflammation: a two-edged sword--the model of bronchiectasis. Eur J Respir Dis Suppl. 1986;147:6-15.
- Results publication: PubMed 29225146Hahn A, Warnken S, Perez-Losada M, Freishtat RJ, Crandall KA. Microbial diversity within the airway microbiome in chronic pediatric lung diseases. Infect Genet Evol. 2018 Sep;63:316-325. doi: 10.1016/j.meegid.2017.12.006. Epub 2017 Dec 7.
- Results publication: PubMed 23646159Zemanick ET, Harris JK, Wagner BD, Robertson CE, Sagel SD, Stevens MJ, Accurso FJ, Laguna TA. Inflammation and airway microbiota during cystic fibrosis pulmonary exacerbations. PLoS One. 2013 Apr 30;8(4):e62917. doi: 10.1371/journal.pone.0062917. Print 2013.
- Results publication: PubMed 20585638Cox MJ, Allgaier M, Taylor B, Baek MS, Huang YJ, Daly RA, Karaoz U, Andersen GL, Brown R, Fujimura KE, Wu B, Tran D, Koff J, Kleinhenz ME, Nielson D, Brodie EL, Lynch SV. Airway microbiota and pathogen abundance in age-stratified cystic fibrosis patients. PLoS One. 2010 Jun 23;5(6):e11044. doi: 10.1371/journal.pone.0011044.
- Results publication: PubMed 31475469Prentice BJ, Wales S, Doumit M, Owens L, Widger J. Children with bronchiectasis have poorer lung function than those with cystic fibrosis and do not receive the same standard of care. Pediatr Pulmonol. 2019 Dec;54(12):1921-1926. doi: 10.1002/ppul.24491. Epub 2019 Sep 1.
- Individual participant dataSharing planned: No. Not to share
Related trials for Bronchiectasis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Recruiting
THERMotherapy Against Persistent Bacterial LUNG Infections
Lung Diseases, Obstructive, Bronchiectasis
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Renal Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
Not yet recruitingPhase 3
A Study to Learn How Well People With Bronchiectasis Tolerate Continued Treatment With Verducatib After Earlier Studies (AIRTIVITY®-ON)
Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna M Nathan principal investigator
UMMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nebulized 5% Hypertonic saline in people with Bronchiectasis, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Short Parent-proxy cough quality of life (PC-QOL) score (time frame: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04765033, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.