Trial · NCT01669421
Effect of Double Dose of Alpha 1-antitrypsin Augmentation Therapy on Lung Inflammation.
NCT01669421, Phase 2, Completed, Michael Campos, MD; results first posted 2019-05-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Double Dose of Alpha 1-antitrypsin Augmentation Therapy on Lung Inflammation. Trials, record NCT01669421. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01669421
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Double Dose of Alpha 1-antitrypsin Augmentation Therapy on Lung Inflammation.
- NCT number
- NCT01669421
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Michael Campos, MD
- Conditions
- Alpha 1 Antitrypsin Deficiency
- Interventions
- Alpha-1 Antitrypsin (human)
- First posted
- 2012-08-21
- Last updated
- 2019-05-08
- Results first posted
- 2019-05-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Inflammatory Biomarkers in Bronchoalveolar Lavage Fluid | Between baseline (week 4), double dose A1PI (week 8) and again standard dose (week 12) | Assess the variations in the levels of several cytokines and inflammatory biomarkers in BAL after changing A1PI dosing. Measures were done using the bead technology. |
| Secondary | Change in Inflammatory Biomarkers in Serum Samples | Between baseline (week 4), double dose A1PI (week 8) and again standard dose (week 12) | Assess the variations in the levels of cytokines and inflammatory biomarkers using the bead technology. |
| Secondary | Number of Adverse Events Reported | From Week 1 to week 12 | |
| Other | Elastin Degradation in BAL | Week 4 vs Week 8 vs Week 12 | Desmosine/isodesmosine measured using mass spectometry. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in Inflammatory Biomarkers in Bronchoalveolar Lavage Fluid | Between baseline (week 4), double dose A1PI (week 8) and again standard dose (week 12) | Subjects with AATD and COPD that require augmentation therapy | pg/ml | MEAN |
| SECONDARY | Change in Inflammatory Biomarkers in Serum Samples | Between baseline (week 4), double dose A1PI (week 8) and again standard dose (week 12) | pg/ml | MEAN | |
| SECONDARY | Number of Adverse Events Reported | From Week 1 to week 12 | Events | NUMBER | |
| OTHER_PRE_SPECIFIED | Elastin Degradation in BAL | Week 4 vs Week 8 vs Week 12 | ng/ml | MEAN |
Source ClinicalTrials.gov
Results by group63
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Inflammatory Biomarkers in Bronchoalveolar Lavage Fluid | Alpha-1 Antitrypsin (Human) Standard Dose Baseline | IL-2 | 14.3 | Standard Deviation 7.3 | pg/ml |
| Changes in Inflammatory Biomarkers in Bronchoalveolar Lavage Fluid | Alpha-1 Antitrypsin (Human) Double Dose | IL-2 | 8.1 | Standard Deviation 3.1 | pg/ml |
| Changes in Inflammatory Biomarkers in Bronchoalveolar Lavage Fluid | Alpha-1 Antitrypsin (Human) Standard Dose | IL-2 | 10.3 | Standard Deviation 1.7 | pg/ml |
| Changes in Inflammatory Biomarkers in Bronchoalveolar Lavage Fluid | Alpha-1 Antitrypsin (Human) Standard Dose Baseline | IL-8 | 379.9 | Standard Deviation 294.3 | pg/ml |
| Changes in Inflammatory Biomarkers in Bronchoalveolar Lavage Fluid | Alpha-1 Antitrypsin (Human) Double Dose | IL-8 | 563.2 | Standard Deviation 317.8 | pg/ml |
| Changes in Inflammatory Biomarkers in Bronchoalveolar Lavage Fluid | Alpha-1 Antitrypsin (Human) Standard Dose | IL-8 | 412.2 | Standard Deviation 160.1 | pg/ml |
| Changes in Inflammatory Biomarkers in Bronchoalveolar Lavage Fluid | Alpha-1 Antitrypsin (Human) Standard Dose Baseline | IL-17 | 79.0 | Standard Deviation 27.8 | pg/ml |
| Changes in Inflammatory Biomarkers in Bronchoalveolar Lavage Fluid | Alpha-1 Antitrypsin (Human) Double Dose | IL-17 | 61.5 | Standard Deviation 15.8 | pg/ml |
| Changes in Inflammatory Biomarkers in Bronchoalveolar Lavage Fluid | Alpha-1 Antitrypsin (Human) Standard Dose | IL-17 | 67.4 | Standard Deviation 8.5 | pg/ml |
| Changes in Inflammatory Biomarkers in Bronchoalveolar Lavage Fluid | Alpha-1 Antitrypsin (Human) Standard Dose Baseline | BASIC FGF | 20.7 | Standard Deviation 9.3 | pg/ml |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1: Standard Dose Therapy | STARTED | Studied Population | 10 | |
| Phase 1: Standard Dose Therapy | COMPLETED | Studied Population | 8 | |
| Phase 1: Standard Dose Therapy | NOT COMPLETED | Studied Population | 2 | |
| Phase 2: Double Dose Therapy | STARTED | Studied Population | 8 | |
| Phase 2: Double Dose Therapy | COMPLETED | Studied Population | 8 | |
| Phase 2: Double Dose Therapy | NOT COMPLETED | Studied Population | 0 | |
| Phase 3: Standard Dose Therapy | STARTED | Studied Population | 8 | |
| Phase 3: Standard Dose Therapy | COMPLETED | Studied Population | 8 | |
| Phase 3: Standard Dose Therapy | NOT COMPLETED | Studied Population | 0 |
Source ClinicalTrials.gov
Adverse events6
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 | Hemoptysis | Respiratory, thoracic and mediastinal disorders | Phase 1: Standard Dose | 1 | 10 | 1 |
| other | Hemoptysis | Respiratory, thoracic and mediastinal disorders | Phase 2: Double Dose | 0 | 8 | 0 |
| other | Hemoptysis | Respiratory, thoracic and mediastinal disorders | Phase 3: Standard Dose | 0 | 8 | 0 |
| other | Respiratory distress | Respiratory, thoracic and mediastinal disorders | Phase 1: Standard Dose | 1 | 10 | 1 |
| other | Respiratory distress | Respiratory, thoracic and mediastinal disorders | Phase 2: Double Dose | 0 | 8 | 0 |
| other | Respiratory distress | Respiratory, thoracic and mediastinal disorders | Phase 3: Standard Dose | 0 | 8 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: Standard Dose | 0 | 10 |
| Total, all-cause mortality | Phase 2: Double Dose | 0 | 8 |
| Total, all-cause mortality | Phase 3: Standard Dose | 0 | 8 |
| Total, other adverse events | Phase 1: Standard Dose | 2 | 10 |
| Total, other adverse events | Phase 2: Double Dose | 0 | 8 |
| Total, other adverse events | Phase 3: Standard Dose | 0 | 8 |
| Total, serious adverse events | Phase 1: Standard Dose | 0 | 10 |
| Total, serious adverse events | Phase 2: Double Dose | 0 | 8 |
| Total, serious adverse events | Phase 3: Standard Dose | 0 | 8 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT01669421
GET https://conductscience.org/api/trials/v1/NCT01669421/results?page=2