Obstructive Pulmonary DiseasesNCT01601288
Database of All Patients Who Have Undergone Pulmonary Function Testing at Singapore General Hospital
An observational study of Obstructive Pulmonary Diseases and Restrictive Lung Disease, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The purpose of this study is to create a prospective database of all patients who have undergone pulmonary function testing from which the investigators can study the clinical phenotypes of various respiratory conditions. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Obstructive Pulmonary Diseases, Restrictive Lung Disease, Cough
- How many people
- 17,000 participants
- Where
- 1 siteSingapore
- Study dates
- May 2012to Dec 2017
- Phase
- Observational
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Prospective data collection of all patients who have undergone pulmonary function testing at Singapore General Hospital
Who may be able to join
- 1) All patients who have undergone pulmonary function testing at the Singapore General Hospital pulmonary function laboratory
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Database of All Patients Who Have Undergone Pulmonary Function Testing at Singapore General Hospital
The purpose of this study is to create a prospective database of all patients who have undergone pulmonary function testing from which the investigators can study the clinical phenotypes of various respiratory conditions. The investigators hope by understanding the differences in these myriad phenotypes to be able to provide individualized, patient-targeted therapy in the future.
Read the detailed description
Recent studies have shown that clinical phenotyping of patients with various respiratory conditions is important in the understanding of the disease process, clinical response to treatment, and prognosis. Pulmonary function testing is a very important aspect of clinical phenotyping in many respiratory conditions. Creating a database will enable us to study the various phenotypes within each respiratory condition. This will allow us to better understand each disease, with a view to provide personalized patient care targeted at their specific phenotype and hence better clinical outcomes.
- Keywords
- obstructive lung disease, restrictive lung disease, cough, dyspnea
- Medical subject headings
- Lung Diseases, Obstructive, Cough, Dyspnea
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnoses based on pulmonary function test interpretation
Interpretation of pulmonary function tests by a certified respiratory physician
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Pulmonary DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 17,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Su Ying Low, BMBCh, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601288
- Sponsor's protocol ID
- 2011/845/Cpftdatabase
- Status last verified
- May 2019
- First submitted
- 15 May 2012
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Nishimura M, Makita H, Nagai K, Konno S, Nasuhara Y, Hasegawa M, Shimizu K, Betsuyaku T, Ito YM, Fuke S, Igarashi T, Akiyama Y, Ogura S; Hokkaido COPD Cohort Study Investigators. Annual change in pulmonary function and clinical phenotype in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2012 Jan 1;185(1):44-52. doi: 10.1164/rccm.201106-0992OC.
PubMed 22016444Nathan SD, Shlobin OA, Weir N, Ahmad S, Kaldjob JM, Battle E, Sheridan MJ, du Bois RM. Long-term course and prognosis of idiopathic pulmonary fibrosis in the new millennium. Chest. 2011 Jul;140(1):221-229. doi: 10.1378/chest.10-2572.
PubMed 21729893
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Database of All Patients Who Have Undergone Pulmonary Function Testing at Singapore General Hospital
- ClinicalTrials.gov ID
- NCT01601288
- Acronym / sponsor ID
- 2011/845/Cpftdatabase
- Keywords
- obstructive lung disease, restrictive lung disease, cough, dyspnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,000 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 May 2012 (estimated)
- 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.
The purpose of this study is to create a prospective database of all patients who have undergone pulmonary function testing from which the investigators can study the clinical phenotypes of various respiratory conditions. The investigators hope by understanding the differences in these myriad phenotypes to be able to provide individualized, patient-targeted therapy in the future.
Detailed description
Recent studies have shown that clinical phenotyping of patients with various respiratory conditions is important in the understanding of the disease process, clinical response to treatment, and prognosis. Pulmonary function testing is a very important aspect of clinical phenotyping in many respiratory conditions. Creating a database will enable us to study the various phenotypes within each respiratory condition. This will allow us to better understand each disease, with a view to provide personalized patient care targeted at their specific phenotype and hence better clinical outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prospective data collection of all patients who have undergone pulmonary function testing at Singapore General Hospital
Key inclusion criteria (1 listed)
- 1) All patients who have undergone pulmonary function testing at the Singapore General Hospital pulmonary function laboratory
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnoses based on pulmonary function test interpretation
Time frame: 7 days
Interpretation of pulmonary function tests by a certified respiratory physician
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 15 May 2019.
- Background: PubMed 22016444Nishimura M, Makita H, Nagai K, Konno S, Nasuhara Y, Hasegawa M, Shimizu K, Betsuyaku T, Ito YM, Fuke S, Igarashi T, Akiyama Y, Ogura S; Hokkaido COPD Cohort Study Investigators. Annual change in pulmonary function and clinical phenotype in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2012 Jan 1;185(1):44-52. doi: 10.1164/rccm.201106-0992OC.
- Background: PubMed 21729893Nathan SD, Shlobin OA, Weir N, Ahmad S, Kaldjob JM, Battle E, Sheridan MJ, du Bois RM. Long-term course and prognosis of idiopathic pulmonary fibrosis in the new millennium. Chest. 2011 Jul;140(1):221-229. doi: 10.1378/chest.10-2572.
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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.
Su Ying Low, BMBCh principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Pulmonary Diseases and Restrictive Lung Disease, run by Singapore General Hospital at 1 site in Singapore.
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 1 inclusion and 0 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 15 May 2019. 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 Singapore. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Diagnoses based on pulmonary function test interpretation (time frame: 7 days). 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 NCT01601288, which also lists 2 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 15 May 2019.