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

NCT01373008 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-08-13

No results posted yet for this study

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.

Conditions

  • Bronchopulmonary Dysplasia

Interventions

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.

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    collaborator OTHER_GOV

  • Schneider Children's Medical Center, Israel

    collaborator OTHER

  • Meir Hospital, Kfar Saba, Israel

    collaborator OTHER

  • Kaplan Medical Center

    collaborator OTHER

  • Barzilai Medical Center

    collaborator OTHER

  • Laniado Hospital

    collaborator OTHER

  • HaEmek Medical Center, Israel

    collaborator OTHER

  • Bnai Zion Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01373008 on ClinicalTrials.gov