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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Bnai Zion Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Tel-Aviv Sourasky Medical Center
Schneider Children's Medical Center, Israel
Meir Hospital, Kfar Saba, Israel
Kaplan Medical Center
Barzilai Medical Center
Laniado Hospital
HaEmek Medical Center, Israel
Information provided by (Responsible Party):
Bnai Zion Medical Center
ClinicalTrials.gov Identifier:
NCT01373008
First received: June 13, 2011
Last updated: February 5, 2013
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Bronchopulmonary Dysplasia
Drug: Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD); Prospective, Double Blind, Randomized Placebo-control, Multi-center Study

Resource links provided by NLM:


Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical outcomes at each visit [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inhaled QVAR
Inhaled QVAR 100 mic via aerochamber twice daily until 3 month post discharge
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.
Placebo Comparator: Inhaled placebo
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.

  Eligibility

Ages Eligible for Study:   up to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373008

Contacts
Contact: Amir Kugelman, MD 972-4-8359063 amirkug@gmail.com

Locations
Israel
Bnai Zion Medical Center Recruiting
Haifa, Israel, 31048
Principal Investigator: Amir Kugelman, MD         
Sponsors and Collaborators
Bnai Zion Medical Center
Tel-Aviv Sourasky Medical Center
Schneider Children's Medical Center, Israel
Meir Hospital, Kfar Saba, Israel
Kaplan Medical Center
Barzilai Medical Center
Laniado Hospital
HaEmek Medical Center, Israel
  More Information

No publications provided

Responsible Party: Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT01373008     History of Changes
Other Study ID Numbers: 0110-10
Study First Received: June 13, 2011
Last Updated: February 5, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Bnai Zion Medical Center:
Inhaled steroids
bronchopulmonary dysplasia
Infants with moderate to severe BPD

Additional relevant MeSH terms:
Infant, Premature, Diseases
Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Newborn, Diseases
Beclomethasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 28, 2014