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| ID | Type | Description | Link |
|---|---|---|---|
| 1466 | Other Identifier | CSL Behring | |
| 2007-007129-38 | EudraCT Number |
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This study is a continuation of the placebo-controlled study CE1226_4001 (NCT00261833) to evaluate the efficacy and safety of Zemaira® intravenous (i.v). administration in subjects with emphysema due to alpha1-proteinase inhibitor deficiency. The long-term verification of a disease-modifying benefit of Zemaira® on the progression of emphysema will be assessed by volume-adjusted lung density, measured yearly by computed tomography (CT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zemaira® | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha1- proteinase inhibitor [human] | Biological | Lyophilized preparation of 60 mg/kg body weight intravenously once per week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Change of Adjusted Lung Density | As measured by centralized, standardized computer tomographic (CT) lung densitometry. CT scans were acquired at 2 inspiration states: TLC (Total Lung Capacity; ie, full inspiration) and FRC (Functional Residual Capacity; ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average rate of decline in the early start and delayed start subgroups from a linear random regression model with country, inspiration state (only for 'TLC and FRC state'), time (time elapsed since Day 1 [CE1226_4001]), treatment and treatment by time interaction as fixed effects and subject and subject by time interaction as random coefficients. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Adjusted Lung Density | Absolute change from baseline to 2 years as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average absolute change in the early start and delayed start subgroups from an analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect. The baseline is the last assessment from the preceding study CE1226_4001. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Program Director, Clinical R&D | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site | Adelaide | South Australia | 5000 | Australia | ||
| Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30237305 | Derived | Greulich T, Chlumsky J, Wencker M, Vit O, Fries M, Chung T, Shebl A, Vogelmeier C, Chapman KR, McElvaney NG; RAPID Trial Group. Safety of biweekly alpha1-antitrypsin treatment in the RAPID programme. Eur Respir J. 2018 Nov 29;52(5):1800897. doi: 10.1183/13993003.00897-2018. Print 2018 Nov. | |
| 27916480 | Derived |
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Subjects who had participated in the CE1226_4001 study, met the inclusion and exclusion criteria, and signed the informed consent were included in study CE1226_3001.
This multicenter study was conducted at 22 centers in Europe, Canada, and Australia.
Alpha1-proteinase inhibitor (A1-PI) deficient individuals with emphysema, who had completed the 2-year treatment and observation periods in study CE1226_4001, except those participating in the USA, were invited to participate in study CE1226_3001.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zemaira® | Alpha1- proteinase inhibitor [human]: Lyophilized preparation of 60 mg/kg body weight administered intravenously once per week |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| From baseline to 2 years |
| Percent Change in Adjusted Lung Density | Percent change from baseline to 2 years as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average percent change in the early start and delayed start subgroups from an analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect. The baseline is the last assessment from the preceding study CE1226_4001. | From baseline to 2 years |
| Change in Subject-reported Symptoms | Patient-reported symptoms were measured using the St George's Respiratory Questionnaire (SGRQ). SGRQ total, symptoms, activity and impact scores range from 0 to 100, with higher scores indicating more limitations, and change from baseline below zero (0) is favorable, indicating improvement. | From baseline to 2 years |
| Percent Change in Lung Function as Measured by Forced Expiratory Volume in 1 Second (FEV1) | From baseline up to 2 years |
| Percent Change in Lung Function as Measured by Ratio of FEV1/FVC (Forced Vital Capacity) | From baseline up to 2 years |
| Percent Change in Lung Function as Measured by Percent Predicted FEV1 | From baseline up to 2 years |
| Number of Subjects With Pulmonary Exacerbations | Up to 2 years |
| Annual Rate in Subject Years of Pulmonary Exacerbations | Annual exposure-adjusted incidence rate of pulmonary exacerbations. | Up to 2 years |
| Time to First Pulmonary Exacerbation | Up to 2 years |
| Percentage of Subjects With Treatment Emergent Adverse Events | Percentage of subjects with treatment-emergent adverse events (TEAEs): overall, by severity, by relatedness, by seriousness, and which occurred within 24 hours of Zemaira administration. | From baseline up to 2.5 years |
| Fitzroy |
| Victoria |
| 3065 |
| Australia |
| Study Site | Darlinghurst | 2010 | Australia |
| Study Site | Nedlands | 6009 | Australia |
| Study Site | New Lambton | 2305 | Australia |
| Study Site | Vancouver | British Columbia | V6J1S3 | Canada |
| Study Site | Halifax | Nova Scotia | B3H 3A7 | Canada |
| Study Site | Toronto | Ontario | M5T 2S8 | Canada |
| Study Site | Praha 4 - Krc | 14059 | Czechia |
| Study Site | Arhus C | 8000 | Denmark |
| Study Site | Hellerup | 2900 | Denmark |
| Study Site | Tartu | 51014 | Estonia |
| Study Site | Oulu | 90220 | Finland |
| Study Site | Essen | 45239 | Germany |
| Study Site | Heidelberg | 69126 | Germany |
| Study Site | Nuremberg | 90419 | Germany |
| Study Site | Dublin | 9 | Ireland |
| Study Site | Krakow | 31-066 | Poland |
| Study Site | Warsaw | 01-138 | Poland |
| Study Site | Bucharest | 011026 | Romania |
| Study Site | Malmö | 20502 | Sweden |
| McElvaney NG, Burdon J, Holmes M, Glanville A, Wark PA, Thompson PJ, Hernandez P, Chlumsky J, Teschler H, Ficker JH, Seersholm N, Altraja A, Makitaro R, Chorostowska-Wynimko J, Sanak M, Stoicescu PI, Piitulainen E, Vit O, Wencker M, Tortorici MA, Fries M, Edelman JM, Chapman KR; RAPID Extension Trial Group. Long-term efficacy and safety of alpha1 proteinase inhibitor treatment for emphysema caused by severe alpha1 antitrypsin deficiency: an open-label extension trial (RAPID-OLE). Lancet Respir Med. 2017 Jan;5(1):51-60. doi: 10.1016/S2213-2600(16)30430-1. Epub 2016 Dec 2. |
| 26026936 | Derived | Chapman KR, Burdon JG, Piitulainen E, Sandhaus RA, Seersholm N, Stocks JM, Stoel BC, Huang L, Yao Z, Edelman JM, McElvaney NG; RAPID Trial Study Group. Intravenous augmentation treatment and lung density in severe alpha1 antitrypsin deficiency (RAPID): a randomised, double-blind, placebo-controlled trial. Lancet. 2015 Jul 25;386(9991):360-8. doi: 10.1016/S0140-6736(15)60860-1. Epub 2015 May 27. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Zemaira® | Alpha1- proteinase inhibitor [human]: Lyophilized preparation of 60 mg/kg body weight intravenously once per week |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | 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 | Rate of Change of Adjusted Lung Density | As measured by centralized, standardized computer tomographic (CT) lung densitometry. CT scans were acquired at 2 inspiration states: TLC (Total Lung Capacity; ie, full inspiration) and FRC (Functional Residual Capacity; ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average rate of decline in the early start and delayed start subgroups from a linear random regression model with country, inspiration state (only for 'TLC and FRC state'), time (time elapsed since Day 1 [CE1226_4001]), treatment and treatment by time interaction as fixed effects and subject and subject by time interaction as random coefficients. | Intention-to-treat (ITT) population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments. | Posted | Least Squares Mean | Standard Error | g/L per year | Up to 2 years |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change in Adjusted Lung Density | Absolute change from baseline to 2 years as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average absolute change in the early start and delayed start subgroups from an analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect. The baseline is the last assessment from the preceding study CE1226_4001. | ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments. | Posted | Least Squares Mean | Standard Error | g/L | From baseline to 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Adjusted Lung Density | Percent change from baseline to 2 years as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average percent change in the early start and delayed start subgroups from an analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect. The baseline is the last assessment from the preceding study CE1226_4001. | ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments. | Posted | Mean | Standard Deviation | Percent change from baseline | From baseline to 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Subject-reported Symptoms | Patient-reported symptoms were measured using the St George's Respiratory Questionnaire (SGRQ). SGRQ total, symptoms, activity and impact scores range from 0 to 100, with higher scores indicating more limitations, and change from baseline below zero (0) is favorable, indicating improvement. | ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments. | Posted | Mean | Standard Deviation | units on a scale (change from baseline) | From baseline to 2 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Lung Function as Measured by Forced Expiratory Volume in 1 Second (FEV1) | ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments. | Posted | Mean | Standard Deviation | Percent change from baseline | From baseline up to 2 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Lung Function as Measured by Ratio of FEV1/FVC (Forced Vital Capacity) | ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments. | Posted | Mean | Standard Deviation | Percent change from baseline | From baseline up to 2 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Lung Function as Measured by Percent Predicted FEV1 | ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments. | Posted | Mean | Standard Deviation | Percent change from baseline | From baseline up to 2 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Pulmonary Exacerbations | ITT population. | Posted | Number | participants | Up to 2 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Annual Rate in Subject Years of Pulmonary Exacerbations | Annual exposure-adjusted incidence rate of pulmonary exacerbations. | ITT population. | Posted | Number | 95% Confidence Interval | Exacerbations/subject year | Up to 2 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Pulmonary Exacerbation | ITT population. | Posted | Median | 95% Confidence Interval | years | Up to 2 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Treatment Emergent Adverse Events | Percentage of subjects with treatment-emergent adverse events (TEAEs): overall, by severity, by relatedness, by seriousness, and which occurred within 24 hours of Zemaira administration. | Safety population comprises all subjects who were included in the study and who received at least 1 dose of Zemaira during study CE1226_3001. | Posted | Number | percentage of subjects | From baseline up to 2.5 years |
|
|
Up to 2.5 years
Treatment-emergent adverse events are presented
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 | Zemaira® | The safety population comprised all subjects enrolled in study CE1226_3001 and who received at least 1 administration of Zemaira® during study CE1226_3001. | 51 | 140 | 137 | 140 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep vein thrombosis | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Hysterectomy | Surgical and medical procedures | MedDRA (15.0) | Systematic Assessment |
| |
| Lung transplant | Surgical and medical procedures | MedDRA (15.0) | Systematic Assessment |
| |
| Strangulated hernia repair | Surgical and medical procedures | MedDRA (15.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nocturnal dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cerebral thrombosis | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | CSL Behring | Use Email contact | clinicaltrials@cslbehring.com |
| ID | Term |
|---|---|
| D004646 | Emphysema |
| D019896 | alpha 1-Antitrypsin Deficiency |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013352 | Subcutaneous Emphysema |
Not provided
Not provided
| ID | Term |
|---|---|
| D000515 | alpha 1-Antitrypsin |
| C000654178 | Respreeza |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D015843 | Serpins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000510 | Alpha-Globulins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Czech Republic |
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| Romania |
|
| Ireland |
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| Finland |
|
| Poland |
|
| Denmark |
|
| Australia |
|
| Germany |
|
| Estonia |
|
| FRC |
|
| Superiority or Other |
| Analysis of the annual rate of change in lung density (for TLC) was a linear random regression model with country, time since Day 1 [CE1226_4001], and treatment-by-time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025. | Regression, Linear | = 0.823 | A 1-sided P-value < 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% CI being > zero) will indicate superiority of Early Start compared with Delayed Start. | Difference in lung density(adjusted P15) | -0.371 | 2-Sided | 95 | -1.159 | 0.417 | No | Superiority or Other |
| Analysis of the annual rate of change in lung density (for FRC) was a linear random regression model with country, time since Day 1 [CE1226_4001], and treatment-by-time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025. | Regression, Linear | = 0.648 | A 1-sided P-value < 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% CI being > zero) will indicate superiority of Early Start compared with Delayed Start. | Difference in lung density(adjusted P15) | -0.176 | 2-Sided | 95 | -1.09 | 0.738 | No | Superiority or Other |
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