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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000210-15 | EudraCT Number |
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Business Decision to Terminate Study
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Single-dose of placebo was administered by oral inhalation via nebulizer, once every week for up to 13 weeks. |
|
| ION-827359 37.5 milligrams (mg) | Experimental | Single-dose of ION-827359 37.5 mg was administered by oral inhalation via nebulizer, once every week for up to 13 weeks. |
|
| ION-827359 75 mg | Experimental | Single-dose of ION-827359 75 mg was administered by oral inhalation via nebulizer, once every week for up to 13 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ION-827359 | Drug | ION-827359 administered by oral inhalation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Baseline up to average of Weeks 13 and 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria
Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements
Males or females. Aged 40-70 inclusive at the time of informed consent
Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or postmenopausal
BMI < 35.0 kg/m^2
Participants with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
i. FEV1/ forced vital capacity (FVC) ratio of < 0.70 ii. FEV1 ≥ 50% and ≤ 90% of predicted normal
Clinically stable COPD in the 4 weeks prior to Screening (Visit 1)
Current and former smokers with smoking history of ≥ 20 pack years
Meet SGRQ definition of CB
CAT score ≥ 10
Exclusion Criteria
Clinically significant abnormalities in medical history (e.g., previous acute coronary syndrome within 6 months of screening, congestive heart failure, major surgery within 3 months of Screening) or physical examination
Screening laboratory results as follows, or any other clinically significant abnormalities in screening laboratory values that would render a subject unsuitable for inclusion
Any active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to first day Study Drug product is administered to the participant (Study Day 1)
Unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator
Clinically important pulmonary disease other than COPD
Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines (GINA 2011) or other accepted guidelines. Participants with a past medical history of asthma (e.g. childhood or adolescence) may be included
Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 4 weeks prior to enrolment (Visit 1)
Acute upper or lower respiratory infection requiring antibiotics or antiviral medication within 4 weeks prior to enrolment (Visit 1)
Long term oxygen therapy (LTOT)
Participants participating in, or scheduled for, an intensive (active) COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible to take part)
Concomitant medication restrictions: Oral anticoagulants, oral steroids (e.g. prednisone or Medrol), theophylline, chronic azithromycin, or roflumilast
Have any other conditions, which, in the opinion of the Investigator would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the Study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MediTrial s.r.o. | Jindřichův Hradec | 37701 | Czechia | |||
| Plicni ambulance Kralupy |
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Of the 60 randomized participants, one was randomized but did not receive study treatment as the participant was ineligible. The study included a 2-week screening period (including a diet-stabilization period), a 12-week treatment period, and a 10-week post-treatment evaluation period.
60 participants were randomized at 11 study centers in Czech Republic, Germany, Hungary and the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Single-dose of placebo was administered by oral inhalation via nebulizer, once every week for up to 13 weeks. |
| FG001 | ION-827359 37.5 Milligrams (mg) | Single-dose of ION-827359 37.5 mg was administered by oral inhalation via nebulizer, once every week for up to 13 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 26, 2021 |
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| Placebo |
| Drug |
Placebo administered by oral inhalation |
|
| ION-827359 | Drug | ION-827359 administered by oral inhalation |
|
| 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). | 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) | 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. | From Baseline to end of treatment (EOT) [Up to Week 14] |
| Cmax: Maximum Observed Plasma Concentration for ION-827359 | Days 1 and 85 |
| Tmax: Time to Reach the Maximum Plasma Concentration for ION-827359 | Days 1 and 85 |
| AUC[0-24h]: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours for ION-827359 | 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. | 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. | 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. | 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. | Up to Week 24 |
| Kralupy nad Vltavou |
| 27801 |
| Czechia |
| CEFISPIRO s.r.o. | Lovosice | 410 02 | Czechia |
| Plicni Ambulance Rokycany, s.r.o. | Rokycany | 33701 | Czechia |
| PNEUMOLOGIE VARNSDORF s.r.o. | Varnsdorf | 40747 | Czechia |
| Pneumologisches Studienzentrum Markgrafenstrasse | Berlin | 10969 | Germany |
| MECS Research GmbH | Berlin | 12203 | Germany |
| Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH | Großhansdorf | 22927 | Germany |
| Hamburger Institut far Therapieforschung GmbH | Hamburg | 20354 | Germany |
| KLB Gesundheitsforschung Lubeck GmbH | Lübeck | 23552 | Germany |
| IKF Pneumologie Mainz Helix Medical Excellence Center Mainz | Mainz | 55128 | Germany |
| ZMS-Zentrum fur medizinische Studien GmbH | Warendorf | 48231 | Germany |
| Csongrad Megyei Mellkasi Betegsegek Szakkorhaza | Deszk | 6772 | Hungary |
| Selye Janos Korhaz, Rendelointezet | Komárom | 2900 | Hungary |
| Queen Anne Street Medical Centre, Heart Lung Center | London | Nw1 8HU | United Kingdom |
| FG002 | ION-827359 75 mg | Single-dose of ION-827359 75 mg was administered by oral inhalation via nebulizer, once every week for up to 13 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population included all the participants who were randomized and received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Single-dose of placebo was administered by oral inhalation via nebulizer, once every week for up to 13 weeks. |
| BG001 | ION-827359 37.5 mg | Single-dose of ION-827359 37.5 mg was administered by oral inhalation via nebulizer, once every week for up to 13 weeks. |
| BG002 | ION-827359 75 mg | Single-dose of ION-827359 75 mg was administered by oral inhalation via nebulizer, once every week for up to 13 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Forced Expiratory Volume in 1 Second (FEV1) | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. | Mean | Standard Deviation | liters |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | FAS=all randomized participants who had ≥1 dose of study drug(ION 827359/placebo),≥1 post-Baseline efficacy assessment(i.e.,post-Baseline FEV1,Exacerbations of Chronic pulmonary Disease Tool[EXACT]Respiratory Symptoms[E-RS]score,Chronic Obstructive Pulmonary Disease[COPD]Assessment Test[CAT]score,or St.George's Respiratory Questionnaire-COPD Specific[SGRQ-C score],post-bronchodilator FEV1).Overall number analyzed:number of participants with data available for analyses in this outcome measure. | Posted | Mean | Standard Deviation | liters | From Baseline up to average of Weeks 13 and 14 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | 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. | FAS included all randomized participants who received at least 1 dose of study drug (ION-827359 or placebo) and who had at least 1 post-Baseline efficacy assessment (i.e., post-Baseline FEV1 assessment, E-RS score, CAT score, or SGRQ-C score). Overall number of participants analyzed is the number of participants with data available for analyses in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | From Baseline up to average of weeks 13 and 14 |
| |||||||||||||||||||||||||||||||||
| Secondary | 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). | FAS included all randomized participants who received at least 1 dose of study drug (ION-827359 or placebo) and who had at least 1 post-Baseline efficacy assessment (i.e., post-Baseline FEV1 assessment, E-RS score, CAT score, or SGRQ-C score). Overall number of participants analyzed is the number of participants with data available for analyses in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | From Baseline to Week 14 |
| |||||||||||||||||||||||||||||||||
| Secondary | 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) | FAS included all randomized participants who received at least 1 dose of study drug (ION-827359 or placebo) and who had at least 1 post-Baseline efficacy assessment (i.e., post-Baseline FEV1 assessment, E-RS score, CAT score, or SGRQ-C score). Overall number of participants analyzed is the number of participants with data available for analyses in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | From Baseline to Week 14 |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | FAS included all randomized participants who received at least 1 dose of study drug (ION-827359 or placebo) and who had at least 1 post-Baseline efficacy assessment (i.e., post-Baseline FEV1 assessment, E-RS score, CAT score, or SGRQ-C score). Overall number of participants analyzed is the number of participants with data available for analyses in this outcome measure. | Posted | Mean | Standard Deviation | liters | From Baseline to end of treatment (EOT) [Up to Week 14] |
| |||||||||||||||||||||||||||||||||
| Secondary | Cmax: Maximum Observed Plasma Concentration for ION-827359 | Pharmacokinetic (PK) population included all participants who were randomized and received at least 1 dose of active study drug (ION-827359) and had at least 1 evaluable PK sample collected and analyzed with reportable result. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Days 1 and 85 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration for ION-827359 | PK population included all participants who were randomized and received at least 1 dose of active study drug (ION-827359) and had at least 1 evaluable PK sample collected and analyzed with reportable result. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | Median | Full Range | hours | Days 1 and 85 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | AUC[0-24h]: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours for ION-827359 | PK population consisted of all the participants who were randomized and received at least 1 dose of active study drug (ION-827359) and had at least 1 evaluable PK sample collected and analyzed with reportable result. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*nanogram per milliliter (h*ng/mL) | Days 1 and 85 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety population included all participants who were randomized and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to Week 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinically Significant Change in Laboratory Values | Laboratory parameters for serum chemistry, hematology, urinalysis, coagulation, complement, and lipids were assessed. | Safety population included all participants who are were randomized and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to Week 24 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinically Significant Change in Vital Sign Parameters | Vital signs included assessment of heart rate, blood pressure, respiratory rate, and temperature. | Safety population included all participants who are were randomized and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to Week 24 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety population included all participants who were randomized and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to Week 24 |
|
|
Up to Week 24
Safety population included all participants who were randomized and received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Single-dose of placebo was administered by oral inhalation via nebulizer, once every week for up to 13 weeks. | 0 | 19 | 1 | 19 | 14 | 19 |
| EG001 | ION-827359 37.5 mg | Single-dose of ION-827359 37.5 mg was administered by oral inhalation via nebulizer, once every week for up to 13 weeks. | 0 | 21 | 1 | 21 | 8 | 21 |
| EG002 | ION-827359 75 mg | Single-dose of ION-827359 75 mg was administered by oral inhalation via nebulizer, once every week for up to 13 weeks. | 0 | 19 | 1 | 19 | 16 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chest pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bronchial irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tongue dry | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Burning sensation | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| FEV1/FVC ratio decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cyanosis | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vaccination complication | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Product taste abnormal | Product Issues | MedDRA 23.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
The study was terminated based on the toxicology findings from a 9-month study and participants who had not completed the treatment period were instructed to terminate dosing and return for an end of study visit, followed by the 10-week follow-up period.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ionis Pharmaceuticals, Inc | Ionis Pharmaceuticals, Inc | 800-679-4747 | patients@ionisph.com |
| Nov 23, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D029481 | Bronchitis, Chronic |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
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| Unknown or Not Reported |
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| ION-827359 37.5 mg |
Single-dose of ION-827359 37.5 mg was administered by oral inhalation via nebulizer, once every week for up to 13 weeks |
| OG002 | ION-827359 75 mg | Single-dose of ION-827359 75 mg was administered by oral inhalation via nebulizer, once every week for up to 13 weeks. |
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| ION-827359 75 mg |
Single-dose of ION-827359 75 mg was administered by oral inhalation via nebulizer, once every week for up to 13 weeks. |
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| OG001 | ION-827359 37.5 mg | Single-dose of ION-827359 37.5 mg was administered by oral inhalation via nebulizer, once every week for up to 13 weeks. |
| OG002 | ION-827359 75 mg | Single-dose of ION-827359 75 mg was administered by oral inhalation via nebulizer, once every week for up to 13 weeks. |
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