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

Bronchopulmonary Dysplasia Clinical Trial

Official title:

Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD); Prospective, Double Blind, Randomized Placebo-control, Multi-center Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01373008
• Other study ID #: 0110-10
• Status: Recruiting
• Phase: Phase 2
• First received: June 13, 2011
• Last updated: August 11, 2015
• Start date: June 2011
• Est. completion date: June 2016

Study information

• Verified date: August 2015
• Source: Bnai Zion Medical Center
• Contact: Amir Kugelman, MD
• Phone: 972-4-8359063
• Email: amirkug[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia

Intervention

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.

Locations

Country	Name	City	State
Israel	Bnai Zion Medical Center	Haifa

Sponsors (8)

Lead Sponsor	Collaborator
Bnai Zion Medical Center	Barzilai Medical Center, HaEmek Medical Center, Israel, Kaplan Medical Center, Laniado Hospital, Meir Hospital, Kfar Saba, Israel, Schneider Children's Medical Center, Israel, Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Clinical outcomes at each visit	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.	4 months	Yes