| Primary | Percentage of Participants With Asthma Exacerbation | An asthma exacerbation was defined as the occurrence of any of the following: ≥30% reduction from baseline in morning PEF on 2 consecutive days; or ≥6 additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; or deterioration of asthma, as determined by the investigator, requiring systemic steroid treatment, or an increase in inhaled corticosteroid (ICS) of ≥4 times the last dose received prior to discontinuation from the study, or hospitalization. The occurrence of asthma exacerbations by individual criteria are reported. | Modified intent-to-treat (mITT) population that included all randomized participants who received at least one dose of study drug. Participants were analysed in the treatment group to which they were randomized. | Posted | | Number | | percentage of participants | | Baseline up to Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo (for Dupilumab) | Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. | | OG001 | Dupilumab 300 mg qw | Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. |
| | | Title | Denominators | Categories |
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| Asthma exacerbation | | | | ≥30% reduction from baseline in morning PEF | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Analysis was performed using a logistic regression model with treatment groups and stratification factor (prior ICS/LABA combination therapy dose) as covariates. | Regression, Logistic | | <0.0001 | Threshold for significance at 0.05 level. | Odds Ratio (OR) | 0.077 | | | 2-Sided | 95 | 0.021 | 0.280 | | | Dupilumab 300 mg vs. Placebo | | Superiority | | |
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| Secondary | Time to First Asthma Exacerbation: Kaplan-Meier Estimates at Week 4, Week 8 and Week 12 | The time-to-asthma exacerbation was defined as the time from the date of randomization to the date of the first asthma exacerbation event; for participants without asthma exacerbation, it was censored at the end of treatment visit date. The median time to first asthma exacerbation was not estimated because the number of asthma exacerbations was too low in the Dupilumab arm. Therefore, alternative Kaplan-Meier statistics, the probability of asthma exacerbation at Week 4, 8 and 12, are presented as the descriptive measure statistics. | | Posted | | Number | 95% Confidence Interval | Probability of asthma exacerbation | | Baseline up to Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo (for Dupilumab) | Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. | | OG001 | Dupilumab 300 mg qw | Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. |
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| Secondary | Percentage of Participants With Composite Asthma Events | Composite asthma event was defined as a 30% or greater reduction from baseline in morning PEF on 2 consecutive days together with 6 or more additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days. | | Posted | | Number | | percentage of participants | | Baseline up to Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo (for Dupilumab) | Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. | | OG001 | Dupilumab 300 mg qw | Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. |
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| Secondary | Change From Baseline in Forced Expiratory Flow in One Second (FEV1) to Week 12 | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. | mITT population. Number of participants analyzed = participants with at least one post-baseline assessment. | Posted | | Mean | Standard Deviation | Liters | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. | | OG001 | Dupilumab 300 mg qw | Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. |
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| Secondary | Change From Baseline in Peak Expiratory Flow (PEF) to Week 12 | The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma. | mITT population. Number analyzed = participants with at least one post-baseline assessment for each category. | Posted | | Mean | Standard Deviation | liters/minute | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo (for Dupilumab) | Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. | | OG001 | Dupilumab 300 mg qw | Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. |
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| Secondary | Change From Baseline in Asthma Control Questionnaire (5-question Version [ACQ-5]) to Week 12 | ACQ-5 questionnaire is a validated questionnaire comprising of 5 questions for asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath, and wheeze. Participants were asked to rate their asthma symptoms during the previous week on a 7-point scale as 0=no impairment, 6=maximum impairment. ACQ-5 score is the mean of the 5 questions and range between 0 (disease totally controlled) and 6 (disease severely uncontrolled), a higher score indicated lower asthma control. | mITT population. Number of participants analyzed = participants with at least one post-baseline assessment. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo (for Dupilumab) | Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. | | OG001 | Dupilumab 300 mg qw | Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. |
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| Secondary | Change From Baseline in 22-item Sinonasal Outcome Test (SNOT-22) Score to Week 12 | The SNOT-22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life. | mITT population. Number of participants analyzed = participants with at least one post-baseline assessment. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo (for Dupilumab) | Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. | | OG001 | Dupilumab 300 mg qw | Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. |
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| Secondary | Change From Baseline in Morning Asthma Symptom Scores to Week 12 | AM (ante meridiem) symptom scoring system rates were participant's overall asthma symptoms experienced during the night. It ranges from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning. No nighttime awakenings,2= Woke up once because of asthma (including early awakening),3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma. | mITT population. Number of participants analyzed = participants with at least one post-baseline assessment. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo (for Dupilumab) | Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. | | OG001 | Dupilumab 300 mg qw | Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. |
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| Secondary | Change From Baseline in Evening Asthma Symptom Scores to Week 12 | PM (post meridiem) symptom scoring system rates were participant's overall asthma symptoms experienced during the day. It ranges from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual. | mITT population. Number of participants analyzed = participants with at least one post-baseline assessment. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo (for Dupilumab) | Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. | | OG001 | Dupilumab 300 mg qw | Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. |
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| Secondary | Change From Baseline in Number of Nocturnal Awakenings Per Day to Week 12 | Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night. | mITT population. Number of participants analyzed = participants with at least one post-baseline assessment. | Posted | | Mean | Standard Deviation | number of awakenings/day | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo (for Dupilumab) | Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. | | OG001 | Dupilumab 300 mg qw | Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. |
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| Secondary | Change From Baseline in Number of Inhalations Per Day of Albuterol or Levalbuterol to Week 12 | Number of Albuterol or Levalbuterol inhalations were recorded daily by the participants in their electronic diary as Albuterol or Levalbuterol was to be used only as needed for symptoms, not on a regular basis or prophylactically. | mITT population. Number of participants analyzed = participants with at least one post-baseline assessment. | Posted | | Mean | Standard Deviation | number of inhalations/day | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo (for Dupilumab) | Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. | | OG001 | Dupilumab 300 mg qw | Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. |
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