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The purpose of this study is to determine whether a single IV dose of N6022 will have a significant bronchoprotective effect, compared with placebo, during methacholine challenge.
The number of patients with adverse events measured in both the treated and placebo groups from start of dosing until Day 28 post dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | N6022 - 5 mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active | Drug | A 5 mg single dose given intravenously via syringe pump over 1 minute. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing | These assessments will be recorded at various times over the study - Methacholine PC20 at screening, and at 8, 24, 48 hours postdose and Day 7; spirometry assessments will be recorded at screening, at 2, 4, 6, 8, 24, 48 hours postdose and Day 7. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing | These assessments will be recorded at various times over the study - Methacholine PC20 at screening, and at 8, 24, 48 hours postdose and Day 7; spirometry assessments will be recorded at screening, at 2, 4, 6, 8, 24, 48 hours postdose and Day 7. | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo After 7 Days of Dosing | 7 Days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rhohit K Katial, MD | National Jewish Health | Principal Investigator |
| Monica Kraft, MD | Duke Asthma, Allergy and Airway Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States | ||
| Duke Asthma, Allergy and Airway Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29642282 | Derived | Que LG, Yang Z, Lugogo NL, Katial RK, Shoemaker SA, Troha JM, Rodman DM, Tighe RM, Kraft M. Effect of the S-nitrosoglutathione reductase inhibitor N6022 on bronchial hyperreactivity in asthma. Immun Inflamm Dis. 2018 Jun;6(2):322-331. doi: 10.1002/iid3.220. Epub 2018 Apr 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | N6022 - Active 5 mg |
| FG001 | Placebo | Non-Active |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sequence 1 |
| |||||||||||||
| Sequence 2 |
|
Any patient that received a dose of N6022 or Placebo
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | N6022 - 5 mg |
| BG001 | Placebo | Non-Active |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing | These assessments will be recorded at various times over the study - Methacholine PC20 at screening, and at 8, 24, 48 hours postdose and Day 7; spirometry assessments will be recorded at screening, at 2, 4, 6, 8, 24, 48 hours postdose and Day 7. | Any patient that received a dose of N6022 or placebo. | Posted | Mean | Standard Error | mg/mL | 24 hours |
|
8 Months
Patients were followed from signing consent through both sequences of the crossover design.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | N6022 - Active 5 mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janice M. Troha | N30 Pharmaceuticals Inc. | 720-945-7714 | janice.troha@n30pharma.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| C571360 | N6022 |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Placebo | Drug | Same as active |
|
| To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma. | Adverse event (AE) reporting will begin upon signing of the consent and will continue until end-of-study (follow up phone call Day 28 +/- 2 days after dosing in the second treatment period). Number of patients with an adverse event will be documented and analyzed. | 10 Weeks |
| Durham |
| North Carolina |
| 27704 |
| United States |
| NOT COMPLETED |
|
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Any patient that received a dose of N6022 or placebo | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients received a single IV administration of 5 mL of placebo on Day 1 in each treatment period and single dose of N6022 on the day 1 of the second period.
|
|
| Secondary | Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing | These assessments will be recorded at various times over the study - Methacholine PC20 at screening, and at 8, 24, 48 hours postdose and Day 7; spirometry assessments will be recorded at screening, at 2, 4, 6, 8, 24, 48 hours postdose and Day 7. | Any patient that received a dose of N6022 or Placebo | Posted | Mean | Standard Error | mg/mL | 8 hours |
|
|
|
| Secondary | To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma. | Adverse event (AE) reporting will begin upon signing of the consent and will continue until end-of-study (follow up phone call Day 28 +/- 2 days after dosing in the second treatment period). Number of patients with an adverse event will be documented and analyzed. | Any patient that received a dose of N6022 or placebo | Posted | Number | Adverse Events | 10 Weeks |
|
|
|
| Other Pre-specified | Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo After 7 Days of Dosing | Any patient that received a dose of N6022 or Placebo | Posted | Mean | Standard Error | mg/mL | 7 Days |
|
|
|
| 0 |
| 14 |
| 11 |
| 14 |
| EG001 | Placebo | Non-Active | 0 | 13 | 9 | 13 |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Injection Site Hematoma | General disorders | MedDRA | Systematic Assessment | administration and site conditions |
|
| Blood Creatinine Increased | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Blood LDH | Investigations | MedDRA | Systematic Assessment |
|
| Blood Phosphorous Decreased | Investigations | MedDRA | Systematic Assessment |
|
| Blood Urine Present | Investigations | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nasal Turminate Abnormality | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pharyngeal Erthyma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory Fatigue | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Allergic Rhinnitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Erthyma | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Injection Site Erthyma | General disorders | MedDRA | Systematic Assessment | administration and site conditions |
|
| Injection Site Induration | General disorders | MedDRA | Systematic Assessment | administration and site conditions |
|
| Injection Site Pain | General disorders | MedDRA | Systematic Assessment | administration and site conditions |
|
| Tenderness | General disorders | MedDRA | Systematic Assessment | administration and site conditions |
|
| ALT Increased | Investigations | MedDRA | Systematic Assessment |
|
| AST Increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | MedDRA | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Thrombophlebitis Superficial | Vascular disorders | MedDRA | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
The investigator agrees with the use of results of the clinical study for the purposes of national and international registration, publication, and information for medical and pharmaceutical professionals. If necessary, the competent authorities will be notified of the investigator's name, address, qualifications, and extent of involvement. An investigator shall not publish any data (poster, abstract, paper, etc.) without having consulted with the Sponsor in advance.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |