Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD)

Phase 2

• Conditions: Bronchopulmonary Dysplasia
• Interventions: Drug: Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)

• Registration Number: NCT01373008
• Lead Sponsor: Bnai Zion Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-13
• Study First Posted: 2011-06-14
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-13
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. 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
2. Parents signed an informed consent
3. The parents will comply with the 3 months study follow-up requirements, as judged by the site principal investigator.

Exclusion Criteria

1. Congenital malformation
2. Cardiac disease (including active PDA)
3. Intraventricular hemorrhage grade III-IV
4. Unstable conditions such as sepsis, apneas, ets. at time of enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhaled QVAR	Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)	Inhaled QVAR 100 mic via aerochamber twice daily until 3 month post discharge
Inhaled placebo	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

Primary Outcome Measures

Name	Time	Method
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.	4 months

Secondary Outcome Measures

Name	Time	Method
Clinical outcomes at each visit	4 months	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.

Trial Locations

Locations (1)

Bnai Zion Medical Center; 🇮🇱 Haifa, Israel