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

NCT01373008 | Unknown Phase 2

• 1 other identifier: 0110-10
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopulmonary Dysplasia

Keywords

Inhaled steroids; bronchopulmonary dysplasia; Infants with moderate to severe BPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical outcomes at each visit

  4 months

Study Arms (2)

Inhaled QVAR

EXPERIMENTAL

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

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

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

Interventions

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.

Inhaled QVAR; Inhaled placebo

Eligibility Criteria

• Age: 3 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bnai Zion Medical Center: lead
• Tel-Aviv Sourasky Medical Center: collaborator
• Schneider Children's Medical Center, Israel: collaborator
• Meir Hospital, Kfar Saba, Israel: collaborator
• Kaplan Medical Center: collaborator
• Barzilai Medical Center: collaborator
• Laniado Hospital: collaborator
• HaEmek Medical Center, Israel: collaborator

Study Sites (1)

Bnai Zion Medical Center

Haifa, 31048, Israel

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Central Study Contacts

Amir Kugelman, MD

CONTACT

972-4-8359063; amirkug@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 14, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

IL (1)