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Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness (ORBEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02148796
Recruitment Status : Active, not recruiting
First Posted : May 28, 2014
Last Update Posted : May 9, 2023
Sponsor:
Information provided by (Responsible Party):
University of Arizona

No Study Results Posted on ClinicalTrials.gov for this Study
Recruitment Status : Active, not recruiting
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025
Publications:
Bousquet J, Anto J, Auffray C, Akdis M, Cambon-Thomsen A, Keil T, Haahtela T, Lambrecht BN, Postma DS, Sunyer J, Valenta R, Akdis CA, Annesi-Maesano I, Arno A, Bachert C, Ballester F, Basagana X, Baumgartner U, Bindslev-Jensen C, Brunekreef B, Carlsen KH, Chatzi L, Crameri R, Eveno E, Forastiere F, Garcia-Aymerich J, Guerra S, Hammad H, Heinrich J, Hirsch D, Jacquemin B, Kauffmann F, Kerkhof M, Kogevinas M, Koppelman GH, Kowalski ML, Lau S, Lodrup-Carlsen KC, Lopez-Botet M, Lotvall J, Lupinek C, Maier D, Makela MJ, Martinez FD, Mestres J, Momas I, Nawijn MC, Neubauer A, Oddie S, Palkonen S, Pin I, Pison C, Rance F, Reitamo S, Rial-Sebbag E, Salapatas M, Siroux V, Smagghe D, Torrent M, Toskala E, van Cauwenberge P, van Oosterhout AJ, Varraso R, von Hertzen L, Wickman M, Wijmenga C, Worm M, Wright J, Zuberbier T. MeDALL (Mechanisms of the Development of ALLergy): an integrated approach from phenotypes to systems medicine. Allergy. 2011 May;66(5):596-604. doi: 10.1111/j.1398-9995.2010.02534.x. Epub 2011 Jan 24.
De Prost Y - Clinical Study Report (BV-2002/1) Multicentric, randomized, double-blind, placebo-controlled study of the efficacy and safety of Broncho-Vaxom® (OM-85 BV) in children suffering from atopic dermatitis. - Clinical Study Report (30 January 2008).
FDA Center for Drug Evaluation and Research (CDER) - Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children. Guidance for Industry: March 2007.
NHIS (2011)] National Health Interview Survey Data - Current Asthma Population Estimates. National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention Hyattsville, MD: http://www.cdc.gov/asthma/nhis/2011/data.htm
NHLBI. National Asthma Education and Prevention Program: Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma; NIH Publication Number 08-5846. October 2007.
Principi N - Clinical Study Report (BV-2005/01) Double-Blind, Placebo-Controlled, Randomised Clinical Study of Broncho-Vaxom in Children Suffering from Recurrent Upper Respiratory Tract Infections. - Clinical Study Report (2 October 2012a).
Principi N - Clinical Study Report (EBV09/01) Double-Blind, Placebo-Controlled, Randomised Clinical Study of Broncho-Vaxom® Drops in Children Suffering from Recurrent Respiratory Tract Infections. - Clinical Study Report (23 October 2012b).
Spertini F - Clinical Study Report (BV-2007/03) Efficacy of Broncho-Vaxom® in Allergic Rhinitis: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study. - Clinical Study Report (31 July 2009)