Trial · NCT03615040

Anti-ST2 (MSTT1041A) in COPD (COPD-ST2OP)

NCT03615040, Phase 2, Completed, University of Leicester; results first posted 2022-05-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Anti-ST2 (MSTT1041A) in COPD (COPD-ST2OP). Trials, record NCT03615040. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03615040

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Anti-ST2 (MSTT1041A) in COPD (COPD-ST2OP)
NCT number: NCT03615040
Status: Completed
Phases: Phase 2
Enrollment: 81 participants, actual
Lead sponsor: University of Leicester
Conditions: COPD Exacerbation
Interventions: MSTT1041A, Placebo
First posted: 2018-08-03
Last updated: 2022-06-21
Other registries' IDs: eudract:2018-000919-24
Results first posted: 2022-05-24
Limitations and caveats: * Small sample size (n=81) at a single site, therefore not powered to detect a reduction in exacerbation frequency that was observed.~* Participants were required to have had a minimum of 2 exacerbations in the previous 12 months, so the findings are not representative for a wider clinical population.~* In response to COVID-19, collection of secondary/exploratory outcomes were reduced, with spirometry and sputum induction discontinued.

Source ClinicalTrials.gov

Registered outcomes33

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Moderate to Severe Exacerbation (Defined as Requiring Treatment With Systemic Corticosteroids and/or Antibiotics in the Community or Hospital or Hospitalisation).	0-48 weeks	Where a COPD exacerbation is defined by symptomatic worsening of COPD requiring: * Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or * Use of antibiotics and/or * inpatient hospitalisation or death due to COPD
Secondary	Adverse Event Rate in the 48 Weeks of the Trial From First Dose	Weeks 0 , 4, 12, 24, 26, 48	Number of Participants with Adverse Events in the 48 Weeks of the Trial From First Dose
Secondary	Serious Adverse Event Rate in the 48 Weeks of the Trial From First Dose	Weeks 0 , 4, 12, 24, 26, 48	Number of Participants with Serious Adverse Events in the 48 Weeks of the Trial From First Dose
Secondary	St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score	Weeks 0, 4, 12, 24, 36, 48	Patient reported outcome (PRO). To evaluate health status; designed to measure health impairment in patients with asthma and COPD. It is in two parts. Part I produces the Symptoms score, and Part 2 the Activity and Impact scores. A Total score is also produced. The Total score is calculated by summing the weights to all the positive responses in each component. This score is then put onto the scale 0 to 100 by dividing by the Total possible sum (3201.9)- and times by 100. A score of 0 would represent the best health and a score of 100 would represent the worst possible state of the patient.
Secondary	COPD Assessment Test (CAT) (Questionnaire)	Weeks 0, 4, 12, 24, 36, 48	Patient reported outcome (PRO). To evaluate health status: evaluation and rehabilitation education guidance on the respiratory and motor functions of patients with chronic obstructive pulmonary disease. CAT score is made by summing the score to eight questions on COPD. For each, the person with COPD picks the number between 0-5 that reflects their response. A zero indicates no effect on quality of life, whereas a 5 suggests a very significant effect.The CAT has a scoring range of 0-40, with 40 indicating the most severe COPD and 0 being the least severe COPD. A change of 2 units suggests a meaningful difference. This test should be used in conjunction with the mMRC and forced expiratory volume in one second (FEV1) to determine COPD health assessment of participants.
Secondary	Modified Medical Research Council (mMRC) Dyspnea Scale	Screening, weeks 0, 4, 12, 24, 36, 48	Patient reported outcome (PRO). To evaluate respiratory breathlessness symptoms (Grade 0-4, with Grade 0 being breathlessness with strenuous exercise to Grade 4 being breathlessness for daily activities like dressing).
Secondary	Visual Analogue Score (VAS) Total and Individual Dyspnoea, Cough, Sputum Production (100mm) Scores	Weeks 0, 4, 12, 24, 36, 48	Patient reported outcome (PRO). To evaluate respiratory symptoms. The participant is asked to place a mark (X) on the scale at the point that best describes their health currently. Minimum score 0mm (better outcome), maximum score 100mm (worse outcome) for each section of the scale (dyspnoea, cough, sputum). The Total VAS score is the sum of the 3 scales, thus the minimum score is 0 (best outcome) and the maximum 300 (worst outcome).
Secondary	Sputum Purulence Colour Card	Screening, week 12, 28, 36, 48	The sputum purulence colour card using the Bronko test has values of 0, 1, 2, 3, 4, 5 and 6. Lower scores indicate better health.
Secondary	Pre and Post Bronchodilator (BD) Spirometry - FEV1/FVC Ratio	Week 0 and Week 48	To assess lung function. The participant will take a maximum inhalation, release maximum exhalation and then continue to exhale afterwards. They will then be treated with a bronchodilator. The spirometry test is then repeated to determine how much the bronchodilator medication helped with breathing. FEV1/FVC ratio will be calculated.
Secondary	Post BD Forced Expiratory Volume in 1 Second (FEV1)	Screening, Weeks 4, 12, 24, 36, 48	To assess lung function. FEV1 is the volume of air that can forcibly be blown out in first 1 second, after full inspiration. Post BD Forced Expiratory Volume in 1 Second (FEV1)

1 to 10 of 33Source ClinicalTrials.gov

See all 33 registered outcomes

Outcomes33

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Moderate to Severe Exacerbation (Defined as Requiring Treatment With Systemic Corticosteroids and/or Antibiotics in the Community or Hospital or Hospitalisation).	0-48 weeks	An intention-to-treat population was used for the primary analysis and all participants were included in the analysis (n = 81). The primary analysis used observed data, meaning only observed exacerbations were used alongside the corresponding time period in the offset of log-time.	Exacerbations	MEAN
SECONDARY	Adverse Event Rate in the 48 Weeks of the Trial From First Dose	Weeks 0 , 4, 12, 24, 26, 48	Safety population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Serious Adverse Event Rate in the 48 Weeks of the Trial From First Dose	Weeks 0 , 4, 12, 24, 26, 48	Safety population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score	Weeks 0, 4, 12, 24, 36, 48	Modified ITT (available data)	score on a scale	MEAN
SECONDARY	COPD Assessment Test (CAT) (Questionnaire)	Weeks 0, 4, 12, 24, 36, 48	Modified ITT (available data)	score on a scale	MEAN
SECONDARY	Modified Medical Research Council (mMRC) Dyspnea Scale	Screening, weeks 0, 4, 12, 24, 36, 48	Modified ITT (available data)	score on a scale	MEDIAN
SECONDARY	Visual Analogue Score (VAS) Total and Individual Dyspnoea, Cough, Sputum Production (100mm) Scores	Weeks 0, 4, 12, 24, 36, 48	Modified ITT (available data)	units on a scale	MEAN
SECONDARY	Sputum Purulence Colour Card	Screening, week 12, 28, 36, 48	Modified ITT (available data)	score on a scale	MEDIAN
SECONDARY	Pre and Post Bronchodilator (BD) Spirometry - FEV1/FVC Ratio	Week 0 and Week 48	Modified ITT (available data)	Ratio	MEAN
SECONDARY	Post BD Forced Expiratory Volume in 1 Second (FEV1)	Screening, Weeks 4, 12, 24, 36, 48	Modified ITT (available data)	Litres	MEAN

1 to 10 of 33Source ClinicalTrials.gov

See all 33 outcomes

Results by group216

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Moderate to Severe Exacerbation (Defined as Requiring Treatment With Systemic Corticosteroids and/or Antibiotics in the Community or Hospital or Hospitalisation).	Anti-ST2		2.21	Standard Deviation 2.04	Exacerbations
Number of Moderate to Severe Exacerbation (Defined as Requiring Treatment With Systemic Corticosteroids and/or Antibiotics in the Community or Hospital or Hospitalisation).	Placebo		2.67	Standard Deviation 2.14	Exacerbations
Adverse Event Rate in the 48 Weeks of the Trial From First Dose	Anti-ST2		34		Participants
Adverse Event Rate in the 48 Weeks of the Trial From First Dose	Placebo		28		Participants
Serious Adverse Event Rate in the 48 Weeks of the Trial From First Dose	Anti-ST2		12		Participants
Serious Adverse Event Rate in the 48 Weeks of the Trial From First Dose	Placebo		16		Participants
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score	Anti-ST2	Baseline	60.1	Standard Deviation 13.7	score on a scale
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score	Placebo	Baseline	58.4	Standard Deviation 17.6	score on a scale
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score	Anti-ST2	Week 4	56.7	Standard Deviation 13.5	score on a scale
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score	Placebo	Week 4	58.9	Standard Deviation 16.5	score on a scale

1 to 10 of 216Source ClinicalTrials.gov

See all 216 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Anti-ST2	42
Overall Study	STARTED	Placebo	39
Overall Study	COMPLETED	Anti-ST2	36
Overall Study	COMPLETED	Placebo	34
Overall Study	NOT COMPLETED	Anti-ST2	6
Overall Study	NOT COMPLETED	Placebo	5

Source ClinicalTrials.gov

Adverse events112

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Arthralgia	Musculoskeletal and connective tissue disorders	Anti-ST2	2	42	3
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo	1	39	1
other	Back pain	Musculoskeletal and connective tissue disorders	Anti-ST2	4	42	5
other	Back pain	Musculoskeletal and connective tissue disorders	Placebo	3	39	4
other	Cellulitis	Infections and infestations	Anti-ST2	0	42	0
other	Cellulitis	Infections and infestations	Placebo	2	39	2
other	Chest pain	General disorders	Anti-ST2	5	42	5
other	Chest pain	General disorders	Placebo	4	39	4
other	Diarrhoea	Gastrointestinal disorders	Anti-ST2	5	42	7
other	Diarrhoea	Gastrointestinal disorders	Placebo	1	39	1

1 to 10 of 112Source ClinicalTrials.gov

See all 112 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Anti-ST2	0	42
Total, all-cause mortality	Placebo	2	39
Total, other adverse events	Anti-ST2	34	42
Total, other adverse events	Placebo	28	39
Total, serious adverse events	Anti-ST2	12	42
Total, serious adverse events	Placebo	16	39

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35339234	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Anti-ST2 vs Placebo: Serious Adverse Event Rate in the 48 Weeks of the Trial From First Dose	Trial comparisons
Anti-ST2 vs Placebo: Adverse Event Rate in the 48 Weeks of the Trial From First Dose	Trial comparisons
Anti-ST2 vs Placebo: deaths from any cause	Trial comparisons
Anti-ST2 vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03615040

GET https://conductscience.org/api/trials/v1/NCT03615040/registered?page=2

API reference For AI assistants