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

Bnai Zion Medical Center

Status and phase: Unknown; Phase 2

Conditions: Bronchopulmonary Dysplasia

Treatments: Drug: Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)

Study type: Interventional

Funder types: Other

Identifiers

NCT01373008

0110-10

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 3 to 12 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Inhaled QVAR

Experimental group

Description:

Inhaled QVAR 100 mic via aerochamber twice daily until 3 month post discharge

Treatment:

Drug: Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)

Inhaled placebo

Placebo Comparator group

Description:

Inhaled nonmedicated MDI \[metered dose inhaler\] in a similarly marked aerosol chamber using the same delivery technique, obtained from the drug manufacturer

Treatment:

Drug: Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)