A Phase 2 interventional study of ION-827359 and Placebo in Chronic Bronchitis and Chronic Obstructive Pulmonary Disease, sponsored by Ionis Pharmaceuticals, Inc.. Terminated at 15 sites in 4 countries. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-12-20.
Sponsored by Ionis Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
The purpose of this study was to evaluate the effect of ION-827359 on forced expiratory volume in 1 second (FEV1) in participants with mild to moderate COPD with CB.
This was a multi-center, double-blind, placebo-controlled, randomized, Phase 2a study of ION-827359 in up to 180 participants. The participants were randomized to receive oral inhalation of either ION-827359 or placebo for up to 13 weeks. At the end of 13 weeks, participants entered a 10-week post-treatment evaluation period.
209 studies on the registry are indexed under Bronchitis, Chronic; 14 are open to participants now.
This study's enrollment of 60 is below the median of 101 across 154 interventional studies indexed under Bronchitis, Chronic.
Browse Bronchitis, Chronic studies →Ionis Pharmaceuticals, Inc. is the lead sponsor of 118 studies on the registry; 10 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 22 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with a diagnosis of as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
i. / forced vital capacity (FVC) ratio of \< 0.70 ii. FEV1 ≥ 50% and ≤ 90% of predicted normal
Exclusion Criteria
Screening laboratory results as follows, or any other clinically significant abnormalities in screening laboratory values that would render a subject unsuitable for inclusion
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single-dose of placebo was administered by oral inhalation via nebulizer, once every week for up to 13 weeks.
Drug: Placebo
Single-dose of ION-827359 37.5 mg was administered by oral inhalation via nebulizer, once every week for up to 13 weeks.
Drug: ION-827359
Single-dose of ION-827359 75 mg was administered by oral inhalation via nebulizer, once every week for up to 13 weeks.
Drug: ION-827359
ION-827359 administered by oral inhalation
Placebo administered by oral inhalation
ION-827359 administered by oral inhalation
Change From Baseline to the Primary Time Point in Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Baseline was defined as the last non-missing measurement prior to the first study drug administration. The primary time point was defined as the average of weeks 13 and 14. FAS=Full analysis set.
Time frame: From Baseline up to average of Weeks 13 and 14
Change From Baseline in the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Respiratory Symptoms (E-RS) Daily Symptom Diary Total Score to the Primary Time Point
The E-RS scale is a participant-reported outcome (PRO) designed to measure the symptoms of participants with chronic obstructive pulmonary disease (COPD). The E-RS utilizes 11 respiratory symptom items from the existing and validated 14-item EXACT, which measures symptoms of exacerbation. The E-RS total score quantifies respiratory symptom severity, and 3 domains assess breathlessness (comprised of 5 items, score range \[0-17\]), cough and sputum (comprised of 3 items, score range \[0-11\]), and chest symptoms (comprised of 3 items, score range \[0-12\]). The E-RS was collected on the daily e-diary. The total score was derived by summing the 11-item scores and ranged between 0 to 40 with higher values indicating severe respiratory symptoms. The primary time point was defined as the average of weeks 13 and 14.
Time frame: From Baseline up to average of weeks 13 and 14
Change From Baseline in the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) to the Week 14 Time Point
The CAT is an eight-item questionnaire that was completed by the participant and is designed to quantify the impact of COPD symptoms on the health status of participants. Each item is rated on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment). The total CAT score is calculated by summing the scores of all items and ranges from 0 to 40. Higher scores indicate a severe condition (more severe impact of COPD on a participant's life).
Time frame: From Baseline to Week 14
Change From Baseline in St. George's Respiratory Questionnaire - COPD Specific (SGRQ-C) Total Score to the Week 14 Time Point
The SGRQ is a participant completed, a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in participants with obstructive airway disease. The shorter 40-item version (SGRQ-C) which does not specify a Recall Period and has been validated specifically for COPD participants was used in this study. It consists of 40 items each weighted from 0 to a possible maximum of 100. Items 1-7 produced the symptoms score, 9-12 the activity score, and items 8, 10, 11, 13 and 14 the impacts score. Each component sub-score was calculated as a percentage of the summed weights of each item out of the sum of the maximum possible weight for that component (range 0-100). The total score was calculated by summing the weights to all positive responses in each component, where a positive item indicated the presence of symptoms, expressed as a percentage (range 0-100). Higher scores indicated a worse outcome (more limitations)
Time frame: From Baseline to Week 14
Change From Baseline in Post-Bronchodilator FEV1
Post-bronchodilator FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation after administration of bronchodilator. Baseline was defined as the last non-missing measurement prior to the first study drug administration.
Time frame: From Baseline to end of treatment (EOT) [Up to Week 14]
Cmax: Maximum Observed Plasma Concentration for ION-827359
Time frame: Days 1 and 85
Tmax: Time to Reach the Maximum Plasma Concentration for ION-827359
Time frame: Days 1 and 85
AUC[0-24h]: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours for ION-827359
Time frame: Days 1 and 85
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) Based on Severity
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of medicinal (investigational) product, whether or not the AE is considered related to the medicinal (investigational) product. A TEAE is defined as any AE starting or getting worse on or after the first dose of the study drug. The severity of a TEAE was assessed by the investigator and classified into one of the following: mild, moderate, and severe.
Time frame: Up to Week 24
Percentage of Participants With Clinically Significant Change in Laboratory Values
Laboratory parameters for serum chemistry, hematology, urinalysis, coagulation, complement, and lipids were assessed.
Time frame: Up to Week 24
Percentage of Participants With Clinically Significant Change in Vital Sign Parameters
Vital signs included assessment of heart rate, blood pressure, respiratory rate, and temperature.
Time frame: Up to Week 24
Percentage of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
ECG parameters of ventricular rate, PR interval, QRS duration, QT, or QTc were assessed.
Time frame: Up to Week 24
60 participants were randomized at 11 study centers in Czech Republic, Germany, Hungary and the United Kingdom.
| Milestone | Placebo | ION-827359 37.5 Milligrams (mg) | ION-827359 75 mg |
|---|---|---|---|
| Started | 20 | 21 | 19 |
| Completed | 3 | 4 | 3 |
| Not completed | 17 | 17 | 16 |
| Withdrew: Voluntary withdrawl | 0 | 1 | 0 |
| Withdrew: Ineligibility | 1 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 4 |
| Withdrew: Study terminated by sponsor | 16 | 16 | 12 |
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Baseline was defined as the last non-missing measurement prior to the first study drug administration. The primary time point was defined as the average of weeks 13 and 14. FAS=Full analysis set.
| liters | Placebo | ION-827359 37.5 mg | ION-827359 75 mg |
|---|---|---|---|
| Change From Baseline to the Primary Time Point in Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo | 0.0642 ± 0.2506 | -0.0240 ± 0.3581 | 0.1336 ± 0.1087 |
The E-RS scale is a participant-reported outcome (PRO) designed to measure the symptoms of participants with chronic obstructive pulmonary disease (COPD). The E-RS utilizes 11 respiratory symptom items from the existing and validated 14-item EXACT, which measures symptoms of exacerbation. The E-RS total score quantifies respiratory symptom severity, and 3 domains assess breathlessness (comprised of 5 items, score range \[0-17\]), cough and sputum (comprised of 3 items, score range \[0-11\]), and chest symptoms (comprised of 3 items, score range \[0-12\]). The E-RS was collected on the daily e-diary. The total score was derived by summing the 11-item scores and ranged between 0 to 40 with higher values indicating severe respiratory symptoms. The primary time point was defined as the average of weeks 13 and 14.
| score on a scale | Placebo | ION-827359 37.5 mg | ION-827359 75 mg |
|---|---|---|---|
| Change From Baseline in the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Respiratory Symptoms (E-RS) Daily Symptom Diary Total Score to the Primary Time Point | -1.08 ± 1.171 | -1.41 ± 2.486 | -1.99 ± 4.217 |
The CAT is an eight-item questionnaire that was completed by the participant and is designed to quantify the impact of COPD symptoms on the health status of participants. Each item is rated on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment). The total CAT score is calculated by summing the scores of all items and ranges from 0 to 40. Higher scores indicate a severe condition (more severe impact of COPD on a participant's life).
| score on a scale | Placebo | ION-827359 37.5 mg | ION-827359 75 mg |
|---|---|---|---|
| Change From Baseline in the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) to the Week 14 Time Point | -2.6 ± 2.51 | -0.6 ± 3.78 | 0.0 ± 1.73 |
The SGRQ is a participant completed, a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in participants with obstructive airway disease. The shorter 40-item version (SGRQ-C) which does not specify a Recall Period and has been validated specifically for COPD participants was used in this study. It consists of 40 items each weighted from 0 to a possible maximum of 100. Items 1-7 produced the symptoms score, 9-12 the activity score, and items 8, 10, 11, 13 and 14 the impacts score. Each component sub-score was calculated as a percentage of the summed weights of each item out of the sum of the maximum possible weight for that component (range 0-100). The total score was calculated by summing the weights to all positive responses in each component, where a positive item indicated the presence of symptoms, expressed as a percentage (range 0-100). Higher scores indicated a worse outcome (more limitations)
| score on a scale | Placebo | ION-827359 37.5 mg | ION-827359 75 mg |
|---|---|---|---|
| Change From Baseline in St. George's Respiratory Questionnaire - COPD Specific (SGRQ-C) Total Score to the Week 14 Time Point | -15.93 ± 19.515 | -1.74 ± 3.839 | -0.76 ± 2.350 |
Post-bronchodilator FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation after administration of bronchodilator. Baseline was defined as the last non-missing measurement prior to the first study drug administration.
| liters | Placebo | ION-827359 37.5 mg | ION-827359 75 mg |
|---|---|---|---|
| Change From Baseline in Post-Bronchodilator FEV1 | 0.0663 ± 0.0685 | 0.0320 ± 0.2379 | 0.1180 ± 0.1006 |
| nanogram per milliliter (ng/mL) | ION-827359 37.5 mg | ION-827359 75 mg |
|---|---|---|
| Day 1 | 85.6 ± 198 | 203 ± 52.6 |
| Day 85 | 53.5 ± NA | 195 ± 124 |
| hours | ION-827359 37.5 mg | ION-827359 75 mg |
|---|---|---|
| Day 1 | 1.54 (0.567 to 2.05) | 1.64 (0.667 to 2.12) |
| Day 85 | 1.98 (1.98 to 1.98) | 3.11 (1.73 to 4.48) |
| hours*nanogram per milliliter (h*ng/mL) | ION-827359 37.5 mg | ION-827359 75 mg |
|---|---|---|
| Day 1 | 528 ± 190 | 1323 ± 66.0 |
| Day 85 | 312 ± NA | 2416 ± 252 |
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of medicinal (investigational) product, whether or not the AE is considered related to the medicinal (investigational) product. A TEAE is defined as any AE starting or getting worse on or after the first dose of the study drug. The severity of a TEAE was assessed by the investigator and classified into one of the following: mild, moderate, and severe.
| percentage of participants | Placebo | ION-827359 37.5 mg | ION-827359 75 mg |
|---|---|---|---|
| Mild | 10.5 | 14.3 | 15.8 |
| Moderate | 52.6 | 38.1 | 63.2 |
| Severe | 10.5 | 0 | 5.3 |
Laboratory parameters for serum chemistry, hematology, urinalysis, coagulation, complement, and lipids were assessed.
| percentage of participants | Placebo | ION-827359 37.5 mg | ION-827359 75 mg |
|---|---|---|---|
| Percentage of Participants With Clinically Significant Change in Laboratory Values | 0 | 0 | 0 |
Vital signs included assessment of heart rate, blood pressure, respiratory rate, and temperature.
| percentage of participants | Placebo | ION-827359 37.5 mg | ION-827359 75 mg |
|---|---|---|---|
| Percentage of Participants With Clinically Significant Change in Vital Sign Parameters | 0 | 0 | 0 |
ECG parameters of ventricular rate, PR interval, QRS duration, QT, or QTc were assessed.
| percentage of participants | Placebo | ION-827359 37.5 mg | ION-827359 75 mg |
|---|---|---|---|
| Percentage of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings | 0 | 0 | 0 |
Collected over Up to Week 24. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/19 (0%) | 1/19 (5.3%) | 14/19 (73.7%) |
| ION-827359 37.5 mg | 0/21 (0%) | 1/21 (4.8%) | 8/21 (38.1%) |
| ION-827359 75 mg | 0/19 (0%) | 1/19 (5.3%) | 16/19 (84.2%) |
| Event | Placebo | ION-827359 37.5 mg | ION-827359 75 mg |
|---|---|---|---|
| Atrial flutterCardiac disorders | 1/19 | 0/21 | 0/19 |
| BronchospasmRespiratory, thoracic and mediastinal disorders | 0/19 | 0/21 | 1/19 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/19 | 0/21 | 1/19 |
| DiarrhoeaGastrointestinal disorders | 0/19 | 1/21 | 0/19 |
| Event | Placebo | ION-827359 37.5 mg | ION-827359 75 mg |
|---|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 1/19 | 5/21 | 7/19 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 5/19 | 0/21 | 4/19 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/19 | 2/21 | 5/19 |
| DiarrhoeaGastrointestinal disorders | 2/19 | 4/21 | 0/19 |
| NasopharyngitisInfections and infestations | 3/19 | 1/21 | 0/19 |
| Sputum increasedRespiratory, thoracic and mediastinal disorders | 0/19 | 0/21 | 2/19 |
| Throat irritationRespiratory, thoracic and mediastinal disorders | 2/19 | 0/21 | 0/19 |
| HeadacheNervous system disorders | 0/19 | 1/21 | 2/19 |
| Burning sensationGeneral disorders | 0/19 | 2/21 | 0/19 |
| Chest painRespiratory, thoracic and mediastinal disorders | 1/19 | 0/21 | 1/19 |
Safety population included all the participants who were randomized and received at least 1 dose of study drug.
| Age, Continuous(years) | Placebo | ION-827359 37.5 mg | ION-827359 75 mg | Total |
|---|---|---|---|---|
| Mean | 61.3 ± 4.54 | 61.8 ± 5.86 | 61.8 ± 5.39 | 61.6 ± 5.23 |
| Sex: Female, Male(Participants) | Placebo | ION-827359 37.5 mg | ION-827359 75 mg | Total |
|---|---|---|---|---|
| Female | 9 | 7 | 5 | 21 |
| Male | 10 | 14 | 14 | 38 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | ION-827359 37.5 mg | ION-827359 75 mg | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 19 | 21 | 19 | 59 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | ION-827359 37.5 mg | ION-827359 75 mg | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 19 | 21 | 18 | 58 |
| More than one race | 0 | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Forced Expiratory Volume in 1 Second (FEV1)(liters) | Placebo | ION-827359 37.5 mg | ION-827359 75 mg | Total |
|---|---|---|---|---|
| Mean | 1.8317 ± 0.4670 | 1.9311 ± 0.6608 | 1.6536 ± 0.3498 | 1.8097 ± 0.5193 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2020 to primary completion in Apr 2021, 4 months.
Results were first posted in Dec 2022, 1 year 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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