Trial · NCT01952470
Preliminary Study of Dornase Alfa to Treat Chest Infections Post Lung Transplant.
NCT01952470, Phase 2, Completed, The Alfred; results first posted 2019-08-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Preliminary Study of Dornase Alfa to Treat Chest Infections Post Lung Transplant. Trials, record NCT01952470. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01952470
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Preliminary Study of Dornase Alfa to Treat Chest Infections Post Lung Transplant.
- NCT number
- NCT01952470
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- The Alfred
- Conditions
- Lung Transplant Infection, Lower Respiratory Tract Infection
- Interventions
- Dornase Alfa, Isotonic Saline.
- First posted
- 2013-09-30
- Last updated
- 2019-08-28
- Results first posted
- 2019-08-28
- Limitations and caveats
Pre-existing/new diagnoses CLAD +/- LRTI; Participants deviating from protocol; Potential for performance bias; Infection control excluded viral LRTI; Single center trial; Participants were \>2 months post-tx.
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Lung Clearance Index 2% (LCI2%) | 1 month, 3 months | A measure of ventilation inhomogeneity as measured during multiple breath washout (MBW) of inert tracer gases. It has been shown that this test is a potentially more sensitive measure of peripheral airway obstruction than regular spirometry in short term (4 week) mucolytic interventional studies in pediatric Cystic Fibrosis (CF)(17-18). This test would be performed within the respiratory physiology lung function laboratory on site at all assessment points, by an assessor who is blinded to group allocation for follow up data collection. Conventionally used primary endpoints in this population, such as regular spirometry(3), may be unable to detect between group differences without large sample sizes and long treatment durations. Based on current evidence from non-lung transplant populations, LCI has been able to show short-term change, whereas regular spirometry has not shown change(17-18). |
| Secondary | Multiple Breath Washout (MBW) | 1 month, 3 months | Multiple breath washout is a sensitive measure of respiratory function performed with the subject in a seated position, breathing a fixed tidal volume (1L) of inert gas (nitrogen) from functional residual capacity (FRC) via mouthpiece. Two common outcomes of MBW are Sacin, a measure of gas mixing at the diffusion front, or acinar entrance in the airways, and Scond, in the proximal, conductive zones. An increase in either Sacin or Scond represents an increase in ventilation heterogeneity (deterioration). Both increase with age, normal values are non-zero between 0-0.25(Sacin) and 0-0.1(Scond). |
| Secondary | Functional Residual Capacity (FRC) | 1 month, 3 months | Volume of air remaining in the lungs after normal expiration. |
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) Liters | 1 month, 3 months. | FEV1 is the maximal amount of air you can forcefully exhale in one second. |
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) Percent. | 1 month, 3 months | FEV1 is the maximal amount of air you can forcefully exhale in one second. |
| Secondary | Forced Vital Capacity (FVC) Liters | 1 month, 3 months | Forced vital Capacity (FVC) is a measure of the amount of air someone can forcibly expel out of the lungs after taking a breath to fill the lungs as much as possible. |
| Secondary | Forced Vital Capacity (FVC) Percent | 1 month, 3 months | Forced vital Capacity (FVC) is a measure of the amount of air someone can forcibly expel out of the lungs after taking a breath to fill the lungs as much as possible. |
| Secondary | Forced Expiratory Ratio (FER) | 1 month, 3 months | FER represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC). |
| Secondary | Leicester Cough Questionnaire (LCQ) - Change | 1 month, 3 months. | Cough specific quality of life questionnaire. The LCQ is a 19-question tool, validated in chronic lung disease other than lung transplant(19). Scale 1-7 for physical, psychological, social. Combined score of 3-21 for total. Lower=worse. |
| Secondary | St. George's Respiratory Questionnaire (SGRQ) - Change | 1 month, 3 months. | The SGRQ is a 2-part questionnaire, validated in chronic lung disease other than lung transplant(20). 50 items, 76 weighted responses. Scores range 0-100, higher=worse. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Lung Clearance Index 2% (LCI2%) | 1 month, 3 months | Dropout | Index (change) | MEAN |
| SECONDARY | Multiple Breath Washout (MBW) | 1 month, 3 months | Dropout | Gas mixing index (Sacin / Scond) | MEAN |
| SECONDARY | Functional Residual Capacity (FRC) | 1 month, 3 months | Dropout | Liters (L) | MEAN |
| SECONDARY | Forced Expiratory Volume in 1 Second (FEV1) Liters | 1 month, 3 months. | Dropout | Liters (L) - change | MEAN |
| SECONDARY | Forced Expiratory Volume in 1 Second (FEV1) Percent. | 1 month, 3 months | Dropout | Percent (%) | MEAN |
| SECONDARY | Forced Vital Capacity (FVC) Liters | 1 month, 3 months | Dropout | Liters (L) | MEAN |
| SECONDARY | Forced Vital Capacity (FVC) Percent | 1 month, 3 months | Dropout | Percent (%) | MEAN |
| SECONDARY | Forced Expiratory Ratio (FER) | 1 month, 3 months | Dropout | Ratio | MEAN |
| SECONDARY | Leicester Cough Questionnaire (LCQ) - Change | 1 month, 3 months. | Dropout / loss of data. | score on a scale | MEAN |
| SECONDARY | St. George's Respiratory Questionnaire (SGRQ) - Change | 1 month, 3 months. | Dropout / lost data. | units on a scale | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group100
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Lung Clearance Index 2% (LCI2%) | Dornase Alfa | 1 month | 10.68 | Standard Deviation 1.97 | Index (change) |
| Lung Clearance Index 2% (LCI2%) | Isotonic Saline | 1 month | 11.65 | Standard Deviation 2.33 | Index (change) |
| Lung Clearance Index 2% (LCI2%) | Dornase Alfa | 3 months | 10.09 | Standard Deviation 2.19 | Index (change) |
| Lung Clearance Index 2% (LCI2%) | Isotonic Saline | 3 months | 11.19 | Standard Deviation 2.73 | Index (change) |
| Multiple Breath Washout (MBW) | Dornase Alfa | Sacin 1 month | 0.348 | Standard Deviation 0.155 | Gas mixing index (Sacin / Scond) |
| Multiple Breath Washout (MBW) | Isotonic Saline | Sacin 1 month | 0.383 | Standard Deviation 0.227 | Gas mixing index (Sacin / Scond) |
| Multiple Breath Washout (MBW) | Dornase Alfa | Sacin 3 months | 0.354 | Standard Deviation 0.249 | Gas mixing index (Sacin / Scond) |
| Multiple Breath Washout (MBW) | Isotonic Saline | Sacin 3 months | 0.356 | Standard Deviation 0.188 | Gas mixing index (Sacin / Scond) |
| Multiple Breath Washout (MBW) | Dornase Alfa | Scond 1 month | 0.045 | Standard Deviation 0.037 | Gas mixing index (Sacin / Scond) |
| Multiple Breath Washout (MBW) | Isotonic Saline | Scond 1 month | 0.026 | Standard Deviation 0.037 | Gas mixing index (Sacin / Scond) |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dornase Alfa | 16 | |
| Overall Study | STARTED | Isotonic Saline | 16 | |
| Overall Study | ITT Analysis | Dornase Alfa | 16 | |
| Overall Study | ITT Analysis | Isotonic Saline | 16 | |
| Overall Study | Discontinued Intervention | Dornase Alfa | 2 | |
| Overall Study | Discontinued Intervention | Isotonic Saline | 1 | |
| Overall Study | Death | Dornase Alfa | 1 | |
| Overall Study | Death | Isotonic Saline | 1 | |
| Overall Study | Missing Baseline LCI 2% Data. | Dornase Alfa | 0 | |
| Overall Study | Missing Baseline LCI 2% Data. | Isotonic Saline | 2 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events14
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 | Shortness of breath | Respiratory, thoracic and mediastinal disorders | Dornase Alfa | 1 | 16 | 2 |
| other | Shortness of breath | Respiratory, thoracic and mediastinal disorders | Isotonic Saline | 2 | 16 | 2 |
| other | Chest tightness | Respiratory, thoracic and mediastinal disorders | Dornase Alfa | 0 | 16 | 0 |
| other | Chest tightness | Respiratory, thoracic and mediastinal disorders | Isotonic Saline | 2 | 16 | 2 |
| other | Chest pain | Respiratory, thoracic and mediastinal disorders | Dornase Alfa | 0 | 16 | 0 |
| other | Chest pain | Respiratory, thoracic and mediastinal disorders | Isotonic Saline | 1 | 16 | 1 |
| other | Headache | Nervous system disorders | Dornase Alfa | 0 | 16 | 0 |
| other | Headache | Nervous system disorders | Isotonic Saline | 1 | 16 | 1 |
| other | Hemoptysis | Respiratory, thoracic and mediastinal disorders | Dornase Alfa | 2 | 16 | 2 |
| other | Hemoptysis | Respiratory, thoracic and mediastinal disorders | Isotonic Saline | 0 | 16 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dornase Alfa | 1 | 16 |
| Total, all-cause mortality | Isotonic Saline | 1 | 16 |
| Total, other adverse events | Dornase Alfa | 4 | 16 |
| Total, other adverse events | Isotonic Saline | 3 | 16 |
| Total, serious adverse events | Dornase Alfa | 0 | 16 |
| Total, serious adverse events | Isotonic Saline | 0 | 16 |
Source ClinicalTrials.gov
Papers21
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dornase Alfa vs Isotonic Saline: deaths from any cause | Trial comparisons |
| Dornase Alfa vs Isotonic Saline: serious adverse events | 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.
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/NCT01952470
GET https://conductscience.org/api/trials/v1/NCT01952470/results?page=2