AtelectasisNCT01095276
Impact of Nebulized Dornase Alpha on Mechanically Ventilated Patients
A study testing Pulmozyme (nebulized dornase alpha) and Saline in people with Atelectasis and Ventilation, Mechanical, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
The investigators hypothesized that dornase alpha, administered twice a day (BID) by in-line nebulizer, would improve oxygenation, compliance, and time to extubation in adult patients receiving mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atelectasis, Ventilation, Mechanical
- What is being tested?
- Pulmozyme (nebulized dornase alpha) and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Jan 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- current ventilator use
- onset of lobar or whole lung collapse over the previous 12 hours
- age greater than 18
Who cannot join
- quadriplegia or debilitating neuromuscular condition
- chronic ventilator dependence
- pneumothorax
- frank hemoptysis
- elevated intracranial pressure
- intracranial bleed
Show all 9Show fewer
- pregnancy or active nursing
- concurrent use of other investigational drugs
- history of allergy to Pulmozyme®, Chinese Hamster Ovary-derived biologics, or any of the components of the active or placebo formulations.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, 07183
About this study
Official title: Inhaled Dnase (Pulmozyme®) as a Non-Invasive Treatment of Atelectasis in Mechanically Ventilated Patients
The investigators hypothesized that dornase alpha, administered twice a day (BID) by in-line nebulizer, would improve oxygenation, compliance, and time to extubation in adult patients receiving mechanical ventilation.
Read the detailed description
Background: Lobar or segmental collapse of the lung in mechanically ventilated patients is a relatively common occurrence in the Intensive Care Unit. Available treatments are either labor or time intensive and not highly effective.
Methods: We conducted a randomized, placebo-controlled, double-blind pilot study to determine whether nebulized recombinant human dornase alpha (Pulmozyme, Genentech) improves radiologic and clinical outcomes in ventilated patients with lobar atelectasis. Outcomes of interest were chest radiograph score, oxygenation, lung compliance, and rate of extubation over the first 5 days. The groups consisted of 14 intervention patients and 16 control patients. They were similar with respect to basic demographics, age, gender, and use of therapeutic modalities relating to lung function. Baseline average chest x-ray scores, Pa02/FI02 ratios, and static compliance were not significantly different. Analysis was limited to the first 5 days.
Results: There was a significant improvement in oxygenation for the intervention group at day 5 (p=0.03). There were no significant differences in chest radiograph score, compliance, or rate of extubation. Two patients died in the intervention group, whereas none died in the control group (NS).
Conclusions: These pilot data suggest that inhaled dornase alpha appears to be safe and is associated with improved oxygenation 5 days after initiation of therapy in mechanically ventilated patients compared to placebo. Larger studies are needed to confirm these findings and determine if this intervention decreases ICU morbidity and mortality.
- Conditions
- Atelectasis, Ventilation, Mechanical
- Being tested
- Pulmozyme (nebulized dornase alpha), Saline
- Keywords
- Mechanical Ventilation, Extubation, dornase alpha, oxygenation, chest x ray
- Medical subject headings
- Pulmonary Atelectasis, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmozyme (nebulized dornase alpha)Drug
Also called Pulmozyme, DNase
nebulized dornase alpha: 2.5 mg by in-line nebulizer BID
SalineDrug
Saline packaged identically to the dornase alpha intervention unit doses and coded for blinding by the company providing the intervention drug (dornase alpha).
| Study group | Role | What they receive |
|---|---|---|
| Nebulized saline | Placebo comparator | patients on mechanical ventilation who were randomized to receive a placebo comparator (vehicle solution for dornase alpha) Receives: Drug: Saline |
| dornase alpha | Active comparator | patients on mechanical ventilation who were randomly assigned to receive dornase alpha by in-line nebulization Receives: Drug: Pulmozyme (nebulized dornase alpha) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Chest X Ray Score
Measured: Days 0-30
Secondary outcomes (3)
Oxygenation (Pa02/FI02)
Measured: Days 0-30
Static Lung Compliance
Measured: Days 0-30
Time to Extubation
Measured: Days 0-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startNov 2005
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Investigators
- Jessica N Zitter, MD, MPH, Principal investigator, UMDNJ, Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095276
- Sponsor's protocol ID
- 0120030304
- Status last verified
- Mar 2010
- First submitted
- 28 Jul 2009
- Last updated
- 30 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Dnase (Pulmozyme®) as a Non-Invasive Treatment of Atelectasis in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT01095276
- Acronym / sponsor ID
- 0120030304
- Conditions
- Atelectasis, Ventilation, Mechanical
- Keywords
- Mechanical Ventilation, Extubation, dornase alpha, oxygenation, chest x ray
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 30 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesized that dornase alpha, administered twice a day (BID) by in-line nebulizer, would improve oxygenation, compliance, and time to extubation in adult patients receiving mechanical ventilation.
Detailed description
Background: Lobar or segmental collapse of the lung in mechanically ventilated patients is a relatively common occurrence in the Intensive Care Unit. Available treatments are either labor or time intensive and not highly effective.
Methods: We conducted a randomized, placebo-controlled, double-blind pilot study to determine whether nebulized recombinant human dornase alpha (Pulmozyme, Genentech) improves radiologic and clinical outcomes in ventilated patients with lobar atelectasis. Outcomes of interest were chest radiograph score, oxygenation, lung compliance, and rate of extubation over the first 5 days. The groups consisted of 14 intervention patients and 16 control patients. They were similar with respect to basic demographics, age, gender, and use of therapeutic modalities relating to lung function. Baseline average chest x-ray scores, Pa02/FI02 ratios, and static compliance were not significantly different. Analysis was limited to the first 5 days.
Results: There was a significant improvement in oxygenation for the intervention group at day 5 (p=0.03). There were no significant differences in chest radiograph score, compliance, or rate of extubation. Two patients died in the intervention group, whereas none died in the control group (NS).
Conclusions: These pilot data suggest that inhaled dornase alpha appears to be safe and is associated with improved oxygenation 5 days after initiation of therapy in mechanically ventilated patients compared to placebo. Larger studies are needed to confirm these findings and determine if this intervention decreases ICU morbidity and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulized saline | Placebo comparator | Drug: Salinepatients on mechanical ventilation who were randomized to receive a placebo comparator (vehicle solution for dornase alpha) |
| dornase alpha | Active comparator | Drug: Pulmozyme (nebulized dornase alpha)patients on mechanical ventilation who were randomly assigned to receive dornase alpha by in-line nebulization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- current ventilator use
- onset of lobar or whole lung collapse over the previous 12 hours
- age greater than 18
Key exclusion criteria (9 listed)
- quadriplegia or debilitating neuromuscular condition
- chronic ventilator dependence
- pneumothorax
- frank hemoptysis
- elevated intracranial pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmozyme (nebulized dornase alpha)Also: Pulmozyme, DNasenebulized dornase alpha: 2.5 mg by in-line nebulizer BID | Drug | dornase alpha |
| SalineSaline packaged identically to the dornase alpha intervention unit doses and coded for blinding by the company providing the intervention drug (dornase alpha). | Drug | Nebulized saline |
Primary outcome
Total Chest X Ray Score
Time frame: Days 0-30
3 secondary outcomes
Oxygenation (Pa02/FI02)
Time frame: Days 0-30
Static Lung Compliance
Time frame: Days 0-30
Time to Extubation
Time frame: Days 0-30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica N Zitter, MD, MPH principal investigator
UMDNJ, Department of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmozyme (nebulized dornase alpha) and Saline in people with Atelectasis and Ventilation, Mechanical, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Chest X Ray Score (time frame: Days 0-30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2010.