Pulmonary FibrosisNCT03242759

Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan

An observational study of Pulmonary Fibrosis, run by Boehringer Ingelheim at 10 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a non-interventional, multi-center study to collect data from patients with idiopathic pulmonary fibrosis (IPF) in clinical practice in Taiwan. The study will be carried out at 10 medical centers, the expert centers where IPF patients are mainly managed in Taiwan. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Pulmonary Fibrosis
What is being tested?: nintedanib and pirfenidone
How many people: 101 participants
Where: 10 sitesTaiwan
Study dates: 17 Aug 2017to 18 Feb 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The study will be carried out at 10 medical centers, the expert centers where idiopathic pulmonary fibrosis (IPF) patients are mainly managed in Taiwan.

Who may be able to join

Patients can be included if ALL the following criteria are met:
1.Newly diagnosed with IPF within 6 months based upon recent ATS/ERS/JRS/ALAT IPF guideline (Ref 1, Raghu G, et al. 2011).
Exclusion of other known causes of ILD (e.g. domestic and occupational environmental exposures, connective tissue disease, and drug toxicity).
Assessment of IPF based on HRCT or HRCT and surgical lung biopsy, if available. 2.Patient ≥ 20 years of age 3.Written informed consent prior to participation 4.Patients with further follow-up possible with participating physician during planned study period 5.Ability to read and write in the local language

Who cannot join

Patients should not be included if ANY of the following criteria is met:
Lung transplantation expected within next 6 months.
Inclusion in ongoing clinical trials.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Taiwan10 sites

Chang-Hua Christian Hospital
Changhua, 500
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Far Eastern Memorial Hospital
New Taipei City, 220
China Medical University Hospital
Taichung, 404
Taichung Veterans General Hospital
Taichung, 40705
National Taiwan University Hospital
Taipei, 10048
Taipei Veterans General Hospital
Taipei, 11217
Tri-Service General Hospital
Taipei, 114
Chang Gung Memorial Hospital(Linkou)
Taoyuan, 333

Other trials in Taiwan

About this study

Conditions: Pulmonary Fibrosis
Being tested: nintedanib, pirfenidone
Medical subject headings: Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

nintedanibDrug
Also called OVEF
Drug
pirfenidoneDrug
Drug

Study groups in NCT03242759
Study group	Role	What they receive
patients with idiopathic pulmonary fibrosis (IPF)		Not described Receives: Drug: nintedanib; Drug: pirfenidone

What is being measured

The primary outcome is the main question the study is designed to answer.

Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52
Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 52 was reported.
Measured: At baseline and Week 52.
Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100
Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 100 was reported.
Measured: At baseline and Week 100.
Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52
Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 52 was reported
Measured: At baseline and Week 52.
Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100
Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 100 was reported.
Measured: At baseline and Week 100.
Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52
Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 52 was reported.
Measured: At baseline and Week 52.
Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100
Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 100 was reported.
Measured: At baseline and Week 100.
Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52
Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 52was reported.
Measured: At baseline and Week 52.
Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100
Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 100 was reported.
Measured: At baseline and Week 100.
Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52
Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 52 was reported.
Measured: At baseline and Week 52.
Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100
Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 100 was reported.
Measured: At baseline and Week 100.

Secondary outcomes (9)

Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Time to first acute exacerbation of idiopathic pulmonary fibrosis was reported.
Measured: From baseline until end of follow-up, up to 899 days.
Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52
The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. The questionnaire included 3 subscales measures: symptoms, activity limitation, and social, and emotional impact of disease (each subscale score ranges from 0 to 100 with higher score indicating poorer quality of life). The SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The total score of SGRQ ranged from 0 (no effect on quality of life) to 100 (maximum perceived distress). Thus, a higher score indicated a poorer quality of life. Annual change in score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52 was reported.
Measured: At baseline and Week 52.
Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100
The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. The questionnaire included 3 subscales measures: symptoms, activity limitation, and social, and emotional impact of disease (each subscale score ranges from 0 to 100 with higher score indicating poorer quality of life). The SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The total score of SGRQ ranged from 0 (no effect on quality of life) to 100 (maximum perceived distress). Thus, a higher score indicated a poorer quality of life. Annual change in score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100 was reported.
Measured: At baseline and Week 100.
Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52
The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is an 8-item, health status instrument which provides a method for assessing the impact of COPD on the patient's health and quality of life. The CAT score (ranging from 0 to 40) was calculated for each individual by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status.
Measured: At baseline and Week 52
Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100
The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is an 8-item, health status instrument which provides a method for assessing the impact of COPD on the patient's health and quality of life. The CAT score (ranging from 0 to 40) was calculated for each individual by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status.
Measured: At baseline and Week 100
Annual Change in Six-Minute Walk Test (6MWT) at Week 52
Annual change in Six-Minute Walk Test (6MWT) at Week 52 was reported. The 6MWT measured the distance that a person can walk in 6 minutes, providing information regarding functional capacity, response to therapy and prognosis.
Measured: At baseline and Week 52.
Annual Change in Six-Minute Walk Test (6MWT) at Week 100
Annual change in Six-Minute Walk Test (6MWT) at Week 100 was reported. The 6MWT measured the distance that a person can walk in 6 minutes, providing information regarding functional capacity, response to therapy and prognosis.
Measured: At baseline and Week 100.
Overall Survival
Overall survival was reported. Overall survival was defined as the time from randomization to death due to any cause.
Measured: From baseline until end of follow-up, up to 899 days.
Number of Participants Per Death Reason Categories
Number of participants per death reason categories was reported.
Measured: From baseline until end of follow-up, up to 899 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Aug 201718 Feb 2020

First posted8 Aug 2017
Study start17 Aug 2017
Primary completion18 Feb 2020
Study completion18 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03242759
Sponsor's protocol ID: 1199-0303
Status last verified: Mar 2021
First submitted: 3 Aug 2017
Last updated: 13 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
Not yet recruitingPhase 3
Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
Pulmonary Fibrosis
RecruitingPhase 2
Phase 2 Study to Assess the Safety and Efficacy of ANG003
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
Active, not recruitingPhase 2
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
Idiopathic Pulmonary Fibrosis (IPF)
RecruitingPhase 2
A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.
Idiopathic Pulmonary Fibrosis (IPF)

All Pulmonary Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan
ClinicalTrials.gov ID: NCT03242759
Acronym / sponsor ID: 1199-0303
Conditions: Pulmonary Fibrosis
Study type: Observational
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 17 Aug 2017 (actual)
Primary completion: 18 Feb 2020 (actual)
Study completion: 18 Feb 2020 (actual)
First posted: 8 Aug 2017 (actual)
Results: Posted 8 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
patients with idiopathic pulmonary fibrosis (IPF)	–	Drug: nintedanib, Drug: pirfenidone

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study will be carried out at 10 medical centers, the expert centers where idiopathic pulmonary fibrosis (IPF) patients are mainly managed in Taiwan.

Key inclusion criteria (4 listed)

Patients can be included if ALL the following criteria are met:
1.Newly diagnosed with IPF within 6 months based upon recent ATS/ERS/JRS/ALAT IPF guideline (Ref 1, Raghu G, et al. 2011).
Exclusion of other known causes of ILD (e.g. domestic and occupational environmental exposures, connective tissue disease, and drug toxicity).
Assessment of IPF based on HRCT or HRCT and surgical lung biopsy, if available. 2.Patient ≥ 20 years of age 3.Written informed consent prior to participation 4.Patients with further follow-up possible with participating physician during planned study period 5.Ability to read and write in the local language

Key exclusion criteria (3 listed)

Patients should not be included if ANY of the following criteria is met:

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
nintedanibAlso: OVEFDrug	Drug	patients with idiopathic pulmonary fibrosis (IPF)
pirfenidoneDrug	Drug	patients with idiopathic pulmonary fibrosis (IPF)

Primary outcome

Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52
Time frame: At baseline and Week 52.
Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 52 was reported.
Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100
Time frame: At baseline and Week 100.
Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 100 was reported.
Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52
Time frame: At baseline and Week 52.
Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 52 was reported
Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100
Time frame: At baseline and Week 100.
Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 100 was reported.
Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52
Time frame: At baseline and Week 52.
Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 52 was reported.
Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100
Time frame: At baseline and Week 100.
Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 100 was reported.
Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52
Time frame: At baseline and Week 52.
Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 52was reported.
Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100
Time frame: At baseline and Week 100.
Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 100 was reported.
Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52
Time frame: At baseline and Week 52.
Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 52 was reported.
Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100
Time frame: At baseline and Week 100.
Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 100 was reported.

9 secondary outcomes

Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Time frame: From baseline until end of follow-up, up to 899 days.
Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52
Time frame: At baseline and Week 52.
Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100
Time frame: At baseline and Week 100.
Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52
Time frame: At baseline and Week 52
Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100
Time frame: At baseline and Week 100
Annual Change in Six-Minute Walk Test (6MWT) at Week 52
Time frame: At baseline and Week 52.
Annual Change in Six-Minute Walk Test (6MWT) at Week 100
Time frame: At baseline and Week 100.
Overall Survival
Time frame: From baseline until end of follow-up, up to 899 days.
Number of Participants Per Death Reason Categories
Time frame: From baseline until end of follow-up, up to 899 days.

Results and safety

Results posted to the registry on 8 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	88	53
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug	13	6

Primary outcome: Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52

Time frame: At baseline and Week 52.. Mean (Standard Deviation). Unit: Percentage of predicted FVC

Measure	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug n = 88	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug n = 13
Value	-0.5 (10.78)	4.1 (7.73)

Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug: p = 0.505, Wilcoxon (Mann-Whitney)
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug: p = 0.181, Paired t-test

Population analysed: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Primary outcome: Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100

Time frame: At baseline and Week 100.. Mean (Standard Deviation). Unit: Percentage of predicted FVC

Measure	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug n = 88	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug n = 13
Value	-0.2 (7.74)	-2.5 (4.52)

Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug: p = 0.571, Wilcoxon (Mann-Whitney)
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug: p = 0.232, Paired t-test

Population analysed: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Primary outcome: Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52

Time frame: At baseline and Week 52.. Mean (Standard Deviation). Unit: Percentage of predicted DLco

Measure	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug n = 88	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug n = 13
Value	-7.3 (10.47)	-2.8 (8.27)

Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug: p < 0.001, Wilcoxon (Mann-Whitney)
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug: p = 0.375, Paired t-test

Population analysed: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Primary outcome: Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100

Time frame: At baseline and Week 100.. Mean (Standard Deviation). Unit: Percentage of predicted DLco

Measure	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug n = 88	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug n = 13
Value	0.5 (6.83)	-2.6 (6.26)

Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug: p = 0.027, Wilcoxon (Mann-Whitney)
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug: p = 0.938, Wilcoxon (Mann-Whitney)

Population analysed: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline until end of follow-up, up to 899 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	29 of 88 (33%)	36 of 88 (40.9%)	28 of 88
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug	2 of 13 (15.4%)	2 of 13 (15.4%)	1 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Pulmonary Fibrosis

RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
Not yet recruitingPhase 3
Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
Pulmonary Fibrosis
RecruitingPhase 2
Phase 2 Study to Assess the Safety and Efficacy of ANG003
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
Active, not recruitingPhase 2
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
Idiopathic Pulmonary Fibrosis (IPF)
RecruitingPhase 2
A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.
Idiopathic Pulmonary Fibrosis (IPF)

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.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Fibrosis, run by Boehringer Ingelheim at 10 sites in Taiwan.

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 4 inclusion and 3 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 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Taiwan. 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?

Yes. Results are posted in the registry (first posted 8 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52 (time frame: At baseline and Week 52.). The study lists 10 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 NCT03242759.

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 13 Apr 2021.