Status AsthmaticusPhase 1NCT02872597
Phase I, Placebo-Controlled, Blinded Pilot Study of Ipratropium in Children Admitted to the ICU With Status Asthmaticus
A Phase 1 study testing Ipratropium, 0.9% Sodium Chloride and Albuterol in people with Status Asthmaticus, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
This study is a Phase I study to investigate the addition of inhaled Ipratropium bromide to standard therapy in the treatment of severe asthma attacks in children admitted to the Pediatric Intensive Care Unit. Half of the subjects will receive inhaled Ipratropium, and half will receive an inhaled placebo. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Status Asthmaticus
- What is being tested?
- Ipratropium, 0.9% Sodium Chloride and Albuterol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2016to 16 Aug 2018
- Phase
- Phase 1
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admission to the PICU
- Treatment with continuous albuterol via the Asthma Carepath
- Enrollment occurred within 4 hours of starting continuous albuterol in the PICU
- Treatment with systemic corticosteroids by the clinical team
Who cannot join
- First episode of wheezing that prompted treatment with bronchodilators by medical personnel
- Prior enrollment in this study
- Patients with chronic lung disease requiring routine home oxygen use
- Allergy to inhaled ipratropium or inhaled saline
- Positive pressure ventilation (via an endotracheal tube or a non-invasive mask [e.g. CPAP (continuous positive airway pressure) or BiPAP])
- Pregnancy
Show all 12Show fewer
- Tracheostomy
- Age < 2 years
- Age > 17 years
- Patient with pulmonary hypertension requiring daily therapy
- Patient with cyanotic congenital heart disease
- Cystic fibrosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Rainbow Babies and Children's Hospital (of Univ. Hospitals Case Med. Center)
Cleveland, Ohio, 44106
About this study
Official title: A Phase I, Single Center, Placebo-Controlled, Blinded Pilot Study of Ipratropium Bromide in Children Admitted to the Intensive Care Unit With Status Asthmaticus
This study is a Phase I study to investigate the addition of inhaled Ipratropium bromide to standard therapy in the treatment of severe asthma attacks in children admitted to the Pediatric Intensive Care Unit. Half of the subjects will receive inhaled Ipratropium, and half will receive an inhaled placebo.
Read the detailed description
Status asthmaticus is an acute exacerbation of asthma that often requires treatment in a pediatric intensive care unit (PICU). Standard therapies for status asthmaticus include corticosteroids and bronchodilators, typically albuterol. Ipratropium bromide is also a bronchodilator, but has a different mechanism of action than albuterol. The addition of Ipraropium to children in the Emergency Room with severe asthma exacerbations improves outcomes, so many PICU doctors treat patients with status asthmaticus with Ipratropium. However, two studies of children hospitalized in the general wards of the hospital (not the PICU) show that the addition of Ipratropium to standard care does not effect clinical outcomes. This study is a first step towards determining in Ipratropium is helpful in PICU patients (like it is in ER patients) or if it not helpful (like it is in general ward patients).
- Conditions
- Status Asthmaticus
- Being tested
- Ipratropium, 0.9% Sodium Chloride, Albuterol, corticosteroids
- Medical subject headings
- Status Asthmaticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpratropiumDrug
Also called Atrovent, Duoneb
0.9% Sodium ChlorideDrug
Also called Normal saline
AlbuterolDrug
albuterol prescribed by the clinical team per our PICU's "Asthma Carepath"
corticosteroidsDrug
Also called methylprednisolone, prednisone, dexamethasone, prednisolone
systemic (IV or enteral) corticosteroid prescribed by the clinical team, typically methylprednisolone IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Inhaled ipratropium bromide 250mcg given via nebulization every 6 hours for up to 5 days Receives: Drug: Ipratropium; Drug: Albuterol; Drug: corticosteroids |
| Placebo | Placebo comparator | Inhaled normal saline 1.25mL given via nebulization every 6 hours for up to 5 days Receives: Drug: 0.9% Sodium Chloride; Drug: Albuterol; Drug: corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to q2 Albuterol
In our PICU, status asthmaticus patients are initially treated with continuous nebulization of albuterol. Per a standard assessment/scoring system, the patients are re-assessed each hour. When the patient's symptoms have sufficiently improved, the albuterol is weaned to 2.5mg given every 1hr ("q1hr albuterol") and, subsequently, to 2.5mg given every 2 hours ("q2hr Albuterol"). This outcome will measure the interval between the initiation of continuous albuterol and the second dose of q2hr Albuterol.
Measured: typically 12-48 hours
Secondary outcomes (2)
PICU LOS (length of stay)
The time interval between admission to the PICU and discharge from the PICU, typically to the general ward. Patients are typically transferred to the general ward when they are receiving albuterol every 3 hours.
Measured: This outcome is assessed continually over the course of the study, typically 24-72 hours
Hospital LOS (length of stay)
The time interval between admission to the hospital and discharge from the hospital. Patients are typically discharged from the hospital when they are receiving albuterol every 4 hours.
Measured: This outcome is assessed continually over the course of the study, typically 48-120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start5 Sep 2016
- Primary completion15 Aug 2018
- Study completion16 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Status AsthmaticusStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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 1
- 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 Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Shein, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872597
- Sponsor's protocol ID
- IRB #02-16-18
- Status last verified
- Apr 2019
- First submitted
- 16 Aug 2016
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Qureshi F, Pestian J, Davis P, Zaritsky A. Effect of nebulized ipratropium on the hospitalization rates of children with asthma. N Engl J Med. 1998 Oct 8;339(15):1030-5. doi: 10.1056/NEJM199810083391503.
PubMed 9761804Craven D, Kercsmar CM, Myers TR, O'riordan MA, Golonka G, Moore S. Ipratropium bromide plus nebulized albuterol for the treatment of hospitalized children with acute asthma. J Pediatr. 2001 Jan;138(1):51-58. doi: 10.1067/mpd.2001.110120.
PubMed 11148512Goggin N, Macarthur C, Parkin PC. Randomized trial of the addition of ipratropium bromide to albuterol and corticosteroid therapy in children hospitalized because of an acute asthma exacerbation. Arch Pediatr Adolesc Med. 2001 Dec;155(12):1329-34. doi: 10.1001/archpedi.155.12.1329.
PubMed 11732951Biagini Myers JM, Simmons JM, Kercsmar CM, Martin LJ, Pilipenko VV, Austin SR, Lindsey MA, Amalfitano KM, Guilbert TW, McCoy KS, Forbis SG, McBride JT, Ross KR, Vauthy PA, Khurana Hershey GK. Heterogeneity in asthma care in a statewide collaborative: the Ohio Pediatric Asthma Repository. Pediatrics. 2015 Feb;135(2):271-9. doi: 10.1542/peds.2014-2230. Epub 2015 Jan 19.
PubMed 25601985
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Center, Placebo-Controlled, Blinded Pilot Study of Ipratropium Bromide in Children Admitted to the Intensive Care Unit With Status Asthmaticus
- ClinicalTrials.gov ID
- NCT02872597
- Acronym / sponsor ID
- IRB #02-16-18
- Conditions
- Status Asthmaticus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 5 Sep 2016 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 16 Aug 2018 (actual)
- First posted
- 19 Aug 2016 (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.
This study is a Phase I study to investigate the addition of inhaled Ipratropium bromide to standard therapy in the treatment of severe asthma attacks in children admitted to the Pediatric Intensive Care Unit. Half of the subjects will receive inhaled Ipratropium, and half will receive an inhaled placebo.
Detailed description
Status asthmaticus is an acute exacerbation of asthma that often requires treatment in a pediatric intensive care unit (PICU). Standard therapies for status asthmaticus include corticosteroids and bronchodilators, typically albuterol. Ipratropium bromide is also a bronchodilator, but has a different mechanism of action than albuterol. The addition of Ipraropium to children in the Emergency Room with severe asthma exacerbations improves outcomes, so many PICU doctors treat patients with status asthmaticus with Ipratropium. However, two studies of children hospitalized in the general wards of the hospital (not the PICU) show that the addition of Ipratropium to standard care does not effect clinical outcomes. This study is a first step towards determining in Ipratropium is helpful in PICU patients (like it is in ER patients) or if it not helpful (like it is in general ward patients).
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 |
|---|---|---|
| Treatment | Experimental | Drug: Ipratropium, Drug: Albuterol, Drug: corticosteroidsInhaled ipratropium bromide 250mcg given via nebulization every 6 hours for up to 5 days |
| Placebo | Placebo comparator | Drug: 0.9% Sodium Chloride, Drug: Albuterol, Drug: corticosteroidsInhaled normal saline 1.25mL given via nebulization every 6 hours for up to 5 days |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Admission to the PICU
- Treatment with continuous albuterol via the Asthma Carepath
- Enrollment occurred within 4 hours of starting continuous albuterol in the PICU
- Treatment with systemic corticosteroids by the clinical team
Key exclusion criteria (12 listed)
- First episode of wheezing that prompted treatment with bronchodilators by medical personnel
- Prior enrollment in this study
- Patients with chronic lung disease requiring routine home oxygen use
- Allergy to inhaled ipratropium or inhaled saline
- Positive pressure ventilation (via an endotracheal tube or a non-invasive mask [e.g. CPAP (continuous positive airway pressure) or BiPAP])
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 |
|---|---|---|
| IpratropiumAlso: Atrovent, Duoneb | Drug | Treatment |
| 0.9% Sodium ChlorideAlso: Normal saline | Drug | Placebo |
| Albuterolalbuterol prescribed by the clinical team per our PICU's "Asthma Carepath" | Drug | Placebo, Treatment |
| corticosteroidsAlso: methylprednisolone, prednisone, dexamethasone, prednisolonesystemic (IV or enteral) corticosteroid prescribed by the clinical team, typically methylprednisolone IV | Drug | Placebo, Treatment |
Primary outcome
Time to q2 Albuterol
Time frame: typically 12-48 hours
In our PICU, status asthmaticus patients are initially treated with continuous nebulization of albuterol. Per a standard assessment/scoring system, the patients are re-assessed each hour. When the patient's symptoms have sufficiently improved, the albuterol is weaned to 2.5mg given every 1hr ("q1hr albuterol") and, subsequently, to 2.5mg given every 2 hours ("q2hr Albuterol"). This outcome will measure the interval between the initiation of continuous albuterol and the second dose of q2hr Albuterol.
2 secondary outcomes
PICU LOS (length of stay)
Time frame: This outcome is assessed continually over the course of the study, typically 24-72 hours
Hospital LOS (length of stay)
Time frame: This outcome is assessed continually over the course of the study, typically 48-120 hours
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 18 Apr 2019.
- Background: PubMed 9761804Qureshi F, Pestian J, Davis P, Zaritsky A. Effect of nebulized ipratropium on the hospitalization rates of children with asthma. N Engl J Med. 1998 Oct 8;339(15):1030-5. doi: 10.1056/NEJM199810083391503.
- Background: PubMed 11148512Craven D, Kercsmar CM, Myers TR, O'riordan MA, Golonka G, Moore S. Ipratropium bromide plus nebulized albuterol for the treatment of hospitalized children with acute asthma. J Pediatr. 2001 Jan;138(1):51-58. doi: 10.1067/mpd.2001.110120.
- Background: PubMed 11732951Goggin N, Macarthur C, Parkin PC. Randomized trial of the addition of ipratropium bromide to albuterol and corticosteroid therapy in children hospitalized because of an acute asthma exacerbation. Arch Pediatr Adolesc Med. 2001 Dec;155(12):1329-34. doi: 10.1001/archpedi.155.12.1329.
- Background: PubMed 25601985Biagini Myers JM, Simmons JM, Kercsmar CM, Martin LJ, Pilipenko VV, Austin SR, Lindsey MA, Amalfitano KM, Guilbert TW, McCoy KS, Forbis SG, McBride JT, Ross KR, Vauthy PA, Khurana Hershey GK. Heterogeneity in asthma care in a statewide collaborative: the Ohio Pediatric Asthma Repository. Pediatrics. 2015 Feb;135(2):271-9. doi: 10.1542/peds.2014-2230. Epub 2015 Jan 19.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ipratropium, 0.9% Sodium Chloride and Albuterol in people with Status Asthmaticus, run by University Hospitals Cleveland Medical Center 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 4 inclusion and 12 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 18 Apr 2019. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to q2 Albuterol (time frame: typically 12-48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02872597, which also lists 4 linked publications.
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 18 Apr 2019.