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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000618-39 | EudraCT Number |
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| Name | Class |
|---|---|
| U-BIOPRED Consortium | UNKNOWN |
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The purpose of this study is to establish the safety and tolerability of Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes (U-BIOPRED) human rhinovirus 16 (RV16UB) in healthy and asthmatic participants, and to identify an appropriate dosage of RV16UB in order to study biomarkers in asthmatic participants. The study is divided into 2 parts. Part 1 is a dose-finding study where healthy participants, and asthmatic participants, who were either treated or not treated with a class of long-acting beta antagonists (LABA) will be recruited to undergo nasal challenge with increasing doses of RV16UB. Part 2 is a biomarker study where mild to moderate asthmatics undergo challenge with the most appropriate dose of RV16UB identified in Part 1, based on tolerability and viral effects. .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy 10 TCID50 (Part 1) | Experimental | Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
|
| Healthy 100 TCID50 (Part 1) | Experimental | Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
|
| Healthy 1000 TCID50 (Part 1) | Experimental | Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
|
| Asthmatic non-LABA 10 TCID50 (Part 1) | Experimental | Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
|
| Asthmatic non-LABA 100 TCID50 (Part 1) | Experimental | Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RV16UB | Biological | RV16UB is administered by spraying an atomized viral suspension into a single nostril. Planned doses of RV16UB in Part 1 are 10 Tissue Culture Infective Dose 50 (TCID50), 100 TCID50, 1000 TCID50 and 10,000 TCID50. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Healthy and Asthmatic Participants With Events of Clinical Interest (ECI) (Part 1) | ECI are selected non-serious and serious adverse events which include the following: an overdose of Sponsor's product; requirement for systemic steroids to treat asthma exacerbation related to virus challenge; acute reaction to virus challenge, confirmed through repeat measurement and when considered potentially associated with administration of virus; specified vital sign findings within 4hr of challenge; specified symptom findings within 24hr of challenge; >20% decrease in Forced Expiratory Volume in 1 second (FEV1) relative to baseline within 4hr of challenge; dyspnea associated with drop in FEV1 (within 4hr of challenge) that is unresponsive to a bronchodilator rescue agent within 20 minutes; Grade 2+ deviation from normal values of liver-related laboratory parameters at any time between challenge and day 14. | Up to Day 24 |
| Number of Participants With Serious Adverse Events (SAE) (Parts 1 and 2) | A SAE is any adverse event occurring at any dose or during any use of the Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing in-patient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. | Up to Day 24 |
| Number of Asthmatic Participants Treated With a Viral Dose of 100 TCID50 With Challenge Induced Upper Airway Symptoms (Part 1) | Asthmatic participants from Part 1 were treated with RV16UB virus at a dose of 100 TCID50, and challenge induced upper airway symptoms were monitored with a diary recording Jackson Cold Symptom Score (CSS). The CSS measures 8 cold symptoms, with each symptom scored from 0 (absent) to 3 (severe). The total score ranges from 0-24, with higher scores reflecting greater severity. The number of participants with a CSS score equal or greater than 3 for two days in a row are presented. | Day 1 up to Day 7 |
| Time -Weighted Average (TWA) Percent Change From Baseline (CFB) in Morning FEV1 in Asthmatic Participants on Days 1-7 (Part 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline in Maximum Drop FEV1 of Asthmatic Participants (Part 2) | Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. The FEV1 readings on the evenings of sputum inductions were excluded from the analyses. The percent decrease of the lowest FEV1 measurement after viral challenge compared to the TWA of the baseline FEV1 is presented. The 95% Confidence Interval actually refers to a 95% Credible Interval. The mean percent decrease is anticipated to be different from zero. |
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Inclusion Criteria:
Parts 1 and 2:
Part 1:
Either of the following:
Part 2:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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Male and female healthy participants, and participants with mild-moderate asthma between the ages of 18 and 55 years (inclusive) were enrolled in this trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy 10 TCID50 (Part 1) | Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| FG001 | Healthy 100 TCID50 (Part 1) | Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| FG002 | Healthy 1000 TCID50 (Part 1) | Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| FG003 | Asthmatic Non-LABA 10 TCID50 (Part 1) | Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| FG004 | Asthmatic Non-LABA 100 TCID50 (Part 1) | Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| FG005 | Asthmatic LABA 100 TCID50 (Part 1) | Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| FG006 | Asthmatic Non-LABA 100 TCID50 (Part 2) | Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy 10 TCID50 (Part 1) | Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| BG001 | Healthy 100 TCID50 (Part 1) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Healthy and Asthmatic Participants With Events of Clinical Interest (ECI) (Part 1) | ECI are selected non-serious and serious adverse events which include the following: an overdose of Sponsor's product; requirement for systemic steroids to treat asthma exacerbation related to virus challenge; acute reaction to virus challenge, confirmed through repeat measurement and when considered potentially associated with administration of virus; specified vital sign findings within 4hr of challenge; specified symptom findings within 24hr of challenge; >20% decrease in Forced Expiratory Volume in 1 second (FEV1) relative to baseline within 4hr of challenge; dyspnea associated with drop in FEV1 (within 4hr of challenge) that is unresponsive to a bronchodilator rescue agent within 20 minutes; Grade 2+ deviation from normal values of liver-related laboratory parameters at any time between challenge and day 14. | Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 2 were not analyzed. | Posted | Number | Participants | Up to Day 24 |
Up to day 24
Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
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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 | Healthy 10 TCID50 (Part 1) | Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
| Asthmatic LABA 100 TCID50 (Part 1) | Experimental | Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
|
| Asthmatic non-LABA 100 TCID50 (Part 2) | Experimental | Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
|
| LABA | Drug | Asthmatic participants were treated with LABA as part of their standard of care |
|
Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. FEV1 assessments obtained between 3 am to 3 pm were counted as morning measurements. The TWA CFB morning FEV1 on days 1-7 was calculated as the difference of the mean of estimated day 1-7 morning FEV1 value and the corresponding estimated baseline value. The 95% Confidence Interval actually refers to a 95% Credible Interval. The anticipated mean reduction from baseline is 10%. |
| Baseline and Days 1 - 7 |
| TWA Percent CFB in Evening FEV1 in Asthmatic Participants on Days 1-7 (Part 2) | Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. FEV1 assessments obtained between 3 pm to next day 3 am were counted as evening measurements. The TWA CFB evening FEV1 on days 1-7 was calculated as the difference of the mean of estimated day 1-7 evening FEV1 value and the corresponding estimated baseline value. The FEV1 readings on the evenings of sputum inductions were excluded from the analyses. The 95% Confidence Interval actually refers to a 95% Credible Interval. The anticipated mean reduction from baseline is 10%. | Baseline and Days 1- 7 |
| Change From Baseline in Mean Maximum Jackson Cold Symptom Score (CSS) on Days 1 to 14 in Asthmatic Participants (Part 1) | Asthmatic participants from Part 1 were treated with RV16UB virus, and challenge induced upper airway symptoms were monitored with a diary recording CSS. The CSS measures 8 cold symptoms, with each symptom scored from 0 (absent) to 3 (severe). The total score ranges from 0-24, with higher scores reflecting greater severity, and a positive change from baseline indicating worsening symptoms. | Baseline and Days 1 - 14 |
| Number of Asthmatic Participants Demonstrating at Least 10^3 Copies/ml of Viral RNA in Nasal Lavage Fluid on Days 1 to 14 (Part 1) | Viral RNA was measured by real time reverse transcriptase polymerase chain reaction (qRT-PCR) from nasal lavage fluid collected on day 3 and day 7 from asthmatic participants, and the number of participants with at least 10^3 copies/ml was determined. | Days 1 - 14 |
| Baseline and up to day 7 |
| Mean Change From Baseline in TWA Asthma Control Diary (ACD) Score of Asthmatic Participants on Days 3 to 10 (Part 2) | The ACD contains seven symptom questions (nocturnal awakening, waking in the morning with symptoms, activity limitation, shortness of breath and wheezing) which are answered on rising in the morning and retiring at bedtime. Missing scores are imputed by linear interpolation or extrapolation. Daily ACD score was fit by a Bayesian hierarchical longitudinal model with participant-specific intercept and a fixed categorical effect for day. All baseline (day -7 to day -1) ACD scores are assumed to be with equal mean. The ACD score is the sum of responses to the seven questions, with answers on a 7-point scale (0= no impairment; 6 = maximum impairment) with the score ranging from 0 to 42, and higher scores indicating greater impairment. The 95% Confidence Interval actually refers to a 95% Credible Interval. The mean percent increase is anticipated to be different from zero. | Baseline and Days 3 to 10 |
Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| BG002 | Healthy 1000 TCID50 (Part 1) | Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| BG003 | Asthmatic Non-LABA 10 TCID50 (Part 1) | Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| BG004 | Asthmatic Non-LABA 100 TCID50 (Part 1) | Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| BG005 | Asthmatic LABA 100 TCID50 (Part 1) | Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| BG006 | Asthmatic Non-LABA 100 TCID50 (Part 2) | Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| BG007 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Healthy 10 TCID50 (Part 1) | Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| OG001 | Healthy 100 TCID50 (Part 1) | Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| OG002 | Healthy 1000 TCID50 (Part 1) | Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| OG003 | Asthmatic Non-LABA 10 TCID50 (Part 1) | Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| OG004 | Asthmatic Non-LABA 100 TCID50 (Part 1) | Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| OG005 | Asthmatic LABA 100 TCID50 (Part 1) | Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| OG006 | Asthmatic Non-LABA 100 TCID50 (Part 2) | Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
|
|
| Primary | Number of Participants With Serious Adverse Events (SAE) (Parts 1 and 2) | A SAE is any adverse event occurring at any dose or during any use of the Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing in-patient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. | Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. | Posted | Number | Participants | Up to Day 24 |
|
|
|
| Primary | Number of Asthmatic Participants Treated With a Viral Dose of 100 TCID50 With Challenge Induced Upper Airway Symptoms (Part 1) | Asthmatic participants from Part 1 were treated with RV16UB virus at a dose of 100 TCID50, and challenge induced upper airway symptoms were monitored with a diary recording Jackson Cold Symptom Score (CSS). The CSS measures 8 cold symptoms, with each symptom scored from 0 (absent) to 3 (severe). The total score ranges from 0-24, with higher scores reflecting greater severity. The number of participants with a CSS score equal or greater than 3 for two days in a row are presented. | Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Healthy participants, asthmatics treated with a viral dose of 10 TCID 50, and participants from Part 2 were not analyzed. | Posted | Number | Participants | Day 1 up to Day 7 |
|
|
|
| Primary | Time -Weighted Average (TWA) Percent Change From Baseline (CFB) in Morning FEV1 in Asthmatic Participants on Days 1-7 (Part 2) | Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. FEV1 assessments obtained between 3 am to 3 pm were counted as morning measurements. The TWA CFB morning FEV1 on days 1-7 was calculated as the difference of the mean of estimated day 1-7 morning FEV1 value and the corresponding estimated baseline value. The 95% Confidence Interval actually refers to a 95% Credible Interval. The anticipated mean reduction from baseline is 10%. | Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 1 were not analyzed; one participant who received a viral dose of 67 TCID50, was included in the analysis. | Posted | Mean | 95% Confidence Interval | Percent change | Baseline and Days 1 - 7 |
|
|
|
| Primary | TWA Percent CFB in Evening FEV1 in Asthmatic Participants on Days 1-7 (Part 2) | Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. FEV1 assessments obtained between 3 pm to next day 3 am were counted as evening measurements. The TWA CFB evening FEV1 on days 1-7 was calculated as the difference of the mean of estimated day 1-7 evening FEV1 value and the corresponding estimated baseline value. The FEV1 readings on the evenings of sputum inductions were excluded from the analyses. The 95% Confidence Interval actually refers to a 95% Credible Interval. The anticipated mean reduction from baseline is 10%. | Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 1 were not analyzed; one participant who received a viral dose of 67 TCID 50, was included in the analysis. | Posted | Mean | 95% Confidence Interval | Percent change | Baseline and Days 1- 7 |
|
|
|
| Primary | Change From Baseline in Mean Maximum Jackson Cold Symptom Score (CSS) on Days 1 to 14 in Asthmatic Participants (Part 1) | Asthmatic participants from Part 1 were treated with RV16UB virus, and challenge induced upper airway symptoms were monitored with a diary recording CSS. The CSS measures 8 cold symptoms, with each symptom scored from 0 (absent) to 3 (severe). The total score ranges from 0-24, with higher scores reflecting greater severity, and a positive change from baseline indicating worsening symptoms. | Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Healthy participants, and participants from Part 2 were not analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and Days 1 - 14 |
|
|
|
| Primary | Number of Asthmatic Participants Demonstrating at Least 10^3 Copies/ml of Viral RNA in Nasal Lavage Fluid on Days 1 to 14 (Part 1) | Viral RNA was measured by real time reverse transcriptase polymerase chain reaction (qRT-PCR) from nasal lavage fluid collected on day 3 and day 7 from asthmatic participants, and the number of participants with at least 10^3 copies/ml was determined. | Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Healthy participants, and participants from Part 2 were not analyzed. | Posted | Number | Participants | Days 1 - 14 |
|
|
|
| Secondary | Mean Percent Change From Baseline in Maximum Drop FEV1 of Asthmatic Participants (Part 2) | Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. The FEV1 readings on the evenings of sputum inductions were excluded from the analyses. The percent decrease of the lowest FEV1 measurement after viral challenge compared to the TWA of the baseline FEV1 is presented. The 95% Confidence Interval actually refers to a 95% Credible Interval. The mean percent decrease is anticipated to be different from zero. | Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 1 were not analyzed; one participant who received a viral dose of 67 TCID 50, was included in the analysis. | Posted | Mean | 95% Confidence Interval | Percent change | Baseline and up to day 7 |
|
|
|
| Secondary | Mean Change From Baseline in TWA Asthma Control Diary (ACD) Score of Asthmatic Participants on Days 3 to 10 (Part 2) | The ACD contains seven symptom questions (nocturnal awakening, waking in the morning with symptoms, activity limitation, shortness of breath and wheezing) which are answered on rising in the morning and retiring at bedtime. Missing scores are imputed by linear interpolation or extrapolation. Daily ACD score was fit by a Bayesian hierarchical longitudinal model with participant-specific intercept and a fixed categorical effect for day. All baseline (day -7 to day -1) ACD scores are assumed to be with equal mean. The ACD score is the sum of responses to the seven questions, with answers on a 7-point scale (0= no impairment; 6 = maximum impairment) with the score ranging from 0 to 42, and higher scores indicating greater impairment. The 95% Confidence Interval actually refers to a 95% Credible Interval. The mean percent increase is anticipated to be different from zero. | Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 1 were not analyzed; one participant who received a viral dose of 67 TCID 50, was included in the analysis. | Posted | Mean | 95% Confidence Interval | Score on a scale | Baseline and Days 3 to 10 |
|
|
|
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | Healthy 100 TCID50 (Part 1) | Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. | 0 | 6 | 3 | 6 |
| EG002 | Healthy 1000 TCID50 (Part 1) | Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. | 0 | 6 | 4 | 6 |
| EG003 | Asthmatic Non-LABA 10 TCID50 (Part 1) | Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. | 0 | 6 | 0 | 6 |
| EG004 | Asthmatic Non-LABA 100 TCID50 (Part 1) | Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. | 0 | 6 | 2 | 6 |
| EG005 | Asthmatic LABA 100 TCID50 (Part 1) | Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. | 1 | 6 | 5 | 6 |
| EG006 | Asthmatic Non-LABA 100 TCID50 (Part 2) | Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. | 0 | 23 | 8 | 23 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Bladder candidiasis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |