Trial · NCT00261833

Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency

NCT00261833, Phase 4, Completed, CSL Behring; results first posted 2015-01-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency. Trials, record NCT00261833. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00261833

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency
NCT number: NCT00261833
Status: Completed
Phases: Phase 4
Enrollment: 180 participants, actual
Lead sponsor: CSL Behring
Conditions: Alpha1-proteinase Inhibitor Deficiency, Emphysema
Interventions: Alpha1-proteinase inhibitor, Placebo
First posted: 2005-12-05
Last updated: 2015-01-19
Other registries' IDs: eudract:2005-003459-12
Results first posted: 2015-01-19

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Annual Rate of Change in Lung Density	Over a 2-year period	As measured by centralized, standardized computer tomographic (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 rate of decline in each treatment group.
Secondary	Annual Rate of Pulmonary Exacerbations	Over a 2-year period	Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion. The annual rate was based on the total number of exacerbations and the total number of participant study days for all participants in the specified analysis population and adjusted to 365.25 days.
Secondary	Percent Change in FEV1	From baseline to 2 years	Percent change from baseline to Month 24.
Secondary	Time to First Pulmonary Exacerbation	Over a 2-year period	Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion.
Secondary	Change in Lung Density	From baseline to 2 years	Change from baseline to Month 24 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.
Secondary	Change in Exercise Capacity	From baseline to 2 years	Exercise capacity was measured as distance walked, using the incremental shuttle walk test. Change from baseline to end of treatment (2 years) in exercise capacity was analysed using an analysis of covariance (ANCOVA).
Secondary	Change in Patient-reported Symptoms	From baseline to 2 years	Patient-reported symptoms were measured using the symptoms score component of the St George's Respiratory Questionnaire (SGRQ). SGRQ scores range from 0 to 100, with higher scores indicating more limitations and negative values for change indicating improvement. Change from baseline to end of treatment (2 years) in SGRQ was analysed using an ANCOVA.
Secondary	Frequency and Intensity of Adverse Events (AEs)	Over a 2-year period	Number of participants with at least one AE, and the number of participants with mild, moderate or severe AEs. AE intensity was defined as mild (does not interfere with routine activities), moderate (interferes with routine activities), or severe (impossible to perform routine activities).
Secondary	Percent Change in Percent Predicted FEV1	From baseline to 2 years	Percent change from baseline to Month 24.
Secondary	Percent Change in FEV1 Divided by Forced Vital Capacity	From baseline to 2 years	Percent change from baseline to Month 24.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Annual Rate of Change in Lung Density	Over a 2-year period	All randomized participants with at least 1 valid CT scan.	g/L per year	LEAST_SQUARES_MEAN
SECONDARY	Annual Rate of Pulmonary Exacerbations	Over a 2-year period	All participants with A1-PI deficiency who were included in the study and randomized.	exacerbations per participant year	NUMBER
SECONDARY	Percent Change in FEV1	From baseline to 2 years	All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.	percent change	LEAST_SQUARES_MEAN
SECONDARY	Time to First Pulmonary Exacerbation	Over a 2-year period	All participants with A1-PI deficiency who were included in the study and randomized.	Years	MEDIAN
SECONDARY	Change in Lung Density	From baseline to 2 years	All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least 1 endpoint assessment available.	g/L	LEAST_SQUARES_MEAN
SECONDARY	Change in Exercise Capacity	From baseline to 2 years	All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.	metre	LEAST_SQUARES_MEAN
SECONDARY	Change in Patient-reported Symptoms	From baseline to 2 years	All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Frequency and Intensity of Adverse Events (AEs)	Over a 2-year period	All participants receiving at least 1 infusion of either Zemaira® or placebo.	participants	NUMBER
SECONDARY	Percent Change in Percent Predicted FEV1	From baseline to 2 years	All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.	percent change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change in FEV1 Divided by Forced Vital Capacity	From baseline to 2 years	All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.	percent change	LEAST_SQUARES_MEAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group74

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Annual Rate of Change in Lung Density	Zemaira®	TLC + FRC combined	-1.50	Standard Error 0.22	g/L per year
Annual Rate of Change in Lung Density	Placebo	TLC + FRC combined	-2.12	Standard Error 0.24	g/L per year
Annual Rate of Change in Lung Density	Zemaira®	TLC	-1.45	Standard Error 0.23	g/L per year
Annual Rate of Change in Lung Density	Placebo	TLC	-2.19	Standard Error 0.25	g/L per year
Annual Rate of Change in Lung Density	Zemaira®	FRC	-1.55	Standard Error 0.24	g/L per year
Annual Rate of Change in Lung Density	Placebo	FRC	-2.02	Standard Error 0.26	g/L per year
Annual Rate of Pulmonary Exacerbations	Zemaira®		1.70	95% Confidence Interval 1.51 to 1.89	exacerbations per participant year
Annual Rate of Pulmonary Exacerbations	Placebo		1.42	95% Confidence Interval 1.23 to 1.61	exacerbations per participant year
Percent Change in FEV1	Zemaira®		-4.29	Standard Error 1.26	percent change
Percent Change in FEV1	Placebo		-2.06	Standard Error 1.30	percent change

1 to 10 of 74Source ClinicalTrials.gov

See all 74 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Zemaira®	93
Overall Study	STARTED	Placebo	87
Overall Study	COMPLETED	Zemaira®	84
Overall Study	COMPLETED	Placebo	69
Overall Study	NOT COMPLETED	Zemaira®	9
Overall Study	NOT COMPLETED	Placebo	18

Source ClinicalTrials.gov

Adverse events196

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nasopharyngitis	Infections and infestations	Zemaira®	30	93	54
other	Nasopharyngitis	Infections and infestations	Placebo	26	87	61
other	Lower respiratory tract infection	Infections and infestations	Zemaira®	18	93	88
other	Lower respiratory tract infection	Infections and infestations	Placebo	17	87	68
other	Upper respiratory tract infection	Infections and infestations	Zemaira®	15	93	28
other	Upper respiratory tract infection	Infections and infestations	Placebo	14	87	26
other	Influenza	Infections and infestations	Zemaira®	14	93	14
other	Influenza	Infections and infestations	Placebo	10	87	12
other	Sinusitis	Infections and infestations	Zemaira®	12	93	17
other	Sinusitis	Infections and infestations	Placebo	11	87	19

1 to 10 of 196Source ClinicalTrials.gov

See all 196 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Zemaira®
Total, all-cause mortality	Placebo
Total, other adverse events	Zemaira®	90	93
Total, other adverse events	Placebo	84	87
Total, serious adverse events	Zemaira®	28	93
Total, serious adverse events	Placebo	28	87

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26026936	DERIVED	PubMed
30237305	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Zemaira® vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00261833

GET https://conductscience.org/api/trials/v1/NCT00261833/results?page=2

API reference For AI assistants