A Phase 2 interventional study of Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR) in Bronchopulmonary Dysplasia, sponsored by Bnai Zion Medical Center. Status unknown at 1 site in Israel. Open to participants aged 3 Weeks to 12 Weeks. Per ClinicalTrials.gov, last updated 2015-08-13.
Sponsored by Bnai Zion Medical Center · Phase 2, Interventional, and Treatment
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.
339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 228 interventional studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →Bnai Zion Medical Center is the lead sponsor of 102 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Inhaled QVAR 100 mic via aerochamber twice daily until 3 month post discharge
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
Drug: 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.
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
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.
Time frame: 4 months
This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Bnai Zion Medical Center