Bronchopulmonary DysplasiaPhase 2NCT01373008
Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD)
A Phase 2 study testing Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR) in people with Bronchopulmonary Dysplasia, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
Premature infants with chronic lung disease (bronchopulmonary dysplasia [BPD]) are commonly treated with inhaled steroids, an optional treatment according to textbooks and guidelines . Read more about this study
- Who is it for?
- Ages 3 to 12 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2011to Jun 2016
- Phase
- Phase 2
- 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 3 to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants with moderate to severe BPD, defined as oxygen <30%, or >30% or with positive pressure support at 36 weeks corrected gestational age, respectively
- Parents signed an informed consent
- The parents will comply with the 3 months study follow-up requirements, as judged by the site principal investigator.
Who cannot join
- Congenital malformation
- Cardiac disease (including active PDA)
- Intraventricular hemorrhage grade III-IV
- Unstable conditions such as sepsis, apneas, ets. at time of enrollment.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Bnai Zion Medical Center
Haifa, 31048
Amir Kugelman, MD
About this study
Official title: Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD); Prospective, Double Blind, Randomized Placebo-control, Multi-center Study
Premature infants with chronic lung disease (bronchopulmonary dysplasia [BPD]) are commonly treated with inhaled steroids, an optional treatment according to textbooks and guidelines . However, the evidence supporting this treatment in spontaneously breathing infants is limited, and based on only two randomized, placebo-controlled trials (RCT) with relative small number of infants . The Cochrane review concluded that these studies do not allow firm conclusions with regard to the efficacy of inhaled steroids in non-ventilated infants . Thus, there is no doubt that there is a need for more RCT in order to ascertain the role of inhaled steroids in infants with BPD. Because of its physical properties that theoretically make QVAR an attractive therapy in infants and studies showing it to be as effective as and with similar safety profile as other inhaled steroids in children, the investigators hypothesized that inhaled QVAR will be an effective therapy in infants with BPD.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)
- Keywords
- Inhaled steroids, bronchopulmonary dysplasia, Infants with moderate to severe BPD
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)Drug
Infants will be randomized for Inhaled QVAR 100 microgram or placebo twice daily with spontaneous tidal breathing for 30 seconds via aerochamber with face mask for the study period.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled QVAR | Experimental | Inhaled QVAR 100 mic via aerochamber twice daily until 3 month post discharge Receives: Drug: Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR) |
| Inhaled placebo | Placebo comparator | Inhaled nonmedicated MDI [metered dose inhaler] in a similarly marked aerosol chamber using the same delivery technique, obtained from the drug manufacturer Receives: Drug: Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be to compare the rate of readmissions to the hospital for BPD exacerbation during the study period between infants treated with QVAR vs. placebo.
Measured: 4 months
Secondary outcomes (1)
Clinical outcomes at each visit
During each visit the following parameters will be charted: Date, vital signs (heart rate, respiratory rate, blood pressure, oxygen pulse oximetry) and physical examination (respiratory distress [0-none, 2- mild, 5-severe], wheezing [0-none, 2- mild, 5-severe], crepitations [0-none, 2- mild, 5-severe]). Will check growth, oxygen need, and in some infant adrenal suppression by urine examination.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel-Aviv Sourasky Medical Center, Schneider Children's Medical Center, Israel, Meir Hospital, Kfar Saba, Israel, Kaplan Medical Center, Barzilai Medical Center, Laniado Hospital, HaEmek Medical Center, Israel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373008
- Sponsor's protocol ID
- 0110-10
- Status last verified
- Aug 2015
- First submitted
- 13 Jun 2011
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD); Prospective, Double Blind, Randomized Placebo-control, Multi-center Study
- ClinicalTrials.gov ID
- NCT01373008
- Acronym / sponsor ID
- 0110-10
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Inhaled steroids, bronchopulmonary dysplasia, Infants with moderate to severe BPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Collaborators
- Tel-Aviv Sourasky Medical Center, Schneider Children's Medical Center, Israel, Meir Hospital, Kfar Saba, Israel, Kaplan Medical Center, Barzilai Medical Center, Laniado Hospital, HaEmek Medical Center, Israel
- Study start
- Jun 2011
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 14 Jun 2011 (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.
Premature infants with chronic lung disease (bronchopulmonary dysplasia [BPD]) are commonly treated with inhaled steroids, an optional treatment according to textbooks and guidelines . However, the evidence supporting this treatment in spontaneously breathing infants is limited, and based on only two randomized, placebo-controlled trials (RCT) with relative small number of infants . The Cochrane review concluded that these studies do not allow firm conclusions with regard to the efficacy of inhaled steroids in non-ventilated infants . Thus, there is no doubt that there is a need for more RCT in order to ascertain the role of inhaled steroids in infants with BPD. Because of its physical properties that theoretically make QVAR an attractive therapy in infants and studies showing it to be as effective as and with similar safety profile as other inhaled steroids in children, the investigators hypothesized that inhaled QVAR will be an effective therapy in infants with BPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled QVAR | Experimental | Drug: Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)Inhaled QVAR 100 mic via aerochamber twice daily until 3 month post discharge |
| Inhaled placebo | Placebo comparator | Drug: Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)Inhaled nonmedicated MDI [metered dose inhaler] in a similarly marked aerosol chamber using the same delivery technique, obtained from the drug manufacturer |
Who may qualify
- Ages
- 3 to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infants with moderate to severe BPD, defined as oxygen <30%, or >30% or with positive pressure support at 36 weeks corrected gestational age, respectively
- Parents signed an informed consent
- The parents will comply with the 3 months study follow-up requirements, as judged by the site principal investigator.
Key exclusion criteria (4 listed)
- Congenital malformation
- Cardiac disease (including active PDA)
- Intraventricular hemorrhage grade III-IV
- Unstable conditions such as sepsis, apneas, ets. at time of enrollment.
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 |
|---|---|---|
| Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)Infants will be randomized for Inhaled QVAR 100 microgram or placebo twice daily with spontaneous tidal breathing for 30 seconds via aerochamber with face mask for the study period. | Drug | Inhaled QVAR, Inhaled placebo |
Primary outcome
The primary outcome will be to compare the rate of readmissions to the hospital for BPD exacerbation during the study period between infants treated with QVAR vs. placebo.
Time frame: 4 months
1 secondary outcome
Clinical outcomes at each visit
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR) in people with Bronchopulmonary Dysplasia, run by Bnai Zion Medical Center at 1 site in Israel.
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 4 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: status not confirmed, as of the sponsor's last update on 13 Aug 2015. 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 Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Kugelman, MD (972-4-8359063, amirkug@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be to compare the rate of readmissions to the hospital for BPD exacerbation during the study period between infants treated with QVAR vs. placebo. (time frame: 4 months). 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 13 Aug 2015.