Summary

Objectives:

1)Evaluate the severity of asthma in children starting a contoller therapy for such pathology 
2)Estimate the risk of treatment failure within 6 months of starting controller therapy and compare this risk between different treatments. 
3)Identify risk factors for failure of first controller therapy. 

Study Design:
Prospective cohort study 

Study duration:
The total duration of the study is 12 months. In the first 6 months subjects meeting the study criteria will be recruited, the next 6 months will be follow up. 

Study population:
Children with asthma or wheeze which start treatment with inhaled corticosteroids (ICS), cromoglycates, long acting B-agonists (LABA) or montelukast/zafirlukast (LTRA) 

Exclusion criteria:
1)Cystic fibrosis, BPCO, Broncopulmonary dysplasia 
2)Use of one or more of the following drugs ICS, LTRA, LABA and cromoglycates in the 6 months preceding the study. 

Data collection:
Inclusion and exclusion criteria and severity of asthma 
Such information will be collected by an electronic form on the doctor’s computer which appears in the moment in which he/she prewscribes one of the drugs of interest. 
Severità will be classified according to GINA guidelines. 

Endpoint:
a) Treatment failure. Includes interruption of controller therapy, use of oral steroids, hospitalisation and/or accessing emergency services for asthma. 
b) Exacerbation of asthma. Includes use of oral steroids, hospitalisation and/or accessing emergency services for asthma. 

Analysis
The aim of the study is to establish the severity of asthma at the time of treatment initiation and evaluating the different outcomes (failure, exacerbations) between different controller therapies. 

Expected sample:
A pilot study has shown that in 6 months each paeditarician should have 5-10 children eligible for the study. We expect to enrol 500 children. 

Recruitment was stopped in May 2007 with almost 600 children having been enrolled compared to the 500 expected. These children will be followed for at least 6 months from the prescription of treatment being studied. 
The study started in January 2006 and finished in December 2007.

Partecipants and Collaborations

Coordinators

Miriam CJM Sturkenboom 
Department of Epidemiology and Buiostatistics and medical informatics, Erasmus University Medical Centre, Rotterdam 
Carlo Giaquinto 
Dipartimento di Pediatria, Padova 
Luigi Cantarutti 
Coordinamento Pedianet, PLS, Padova

Partecipants

Alongi Angelo, Avarello Giovanni, Barberi Frandanisa Maria, Barone Roberto, Basoccu Pietro, Biondi Claudio, Bonfigli Emanuela, Bratto Massimo, Budassi Roberto, Cantarutti Luigi, Cera Giuseppe Egidio, Cuboni Giancarlo, Curto Salvatore, De Clara Roberto, De Marchi Annamaria, Doria Mattia, Drago Stefano, Elio Giuseppe, Ferretti Michele, Fusco Fabrizio, Galvagno Andrea, Gentili Alberta, Gentilucci Pierfrancesco, Giancola Giuseppe, Girotto Silvia, Gobbi Costantino, Grillone Giuseppe, Lietti Giuseppe, Lista Cinzia, Lorusso Giuseppe, Macropodio Nadia, Masotti Sergio, Mauri Laura, Mazzini Franco, Milani Massimo, Mirabelli M. Cristina, Mulas Anna, Muzzolini Carmen, Nicoloso Flavia, Olimpi Laura, Pasinato Angela, Passarella Andrea, Rosas Paolo, Rosignoli Rino, Ruffato Bruno, Salamone Pietro, Sambugaro Daniela, Saretta Luigi, Sciolla Nicola, Semenzato Flavio, Senesi Paolo, Spanevello Walter, Speciale Sergio ,Speranza Francesco, Storelli Francesco, Tamassia Gianni, Tambaro Paolo, Terenghi Albino, Toffol Giacomo, Trebbi Miro, Valpreda Andrea, Vannini Paola, Varni Pierfiorenzo, Vertua Guido, Volpe Concetta.

Collaborations

Data Monitor

Antonio Scamarcia 
Società Servizi Telematici, Padova

Computer-related Assistance

Alessandro Zandarin 
Società Servizi Telematici, Padova

Pubblications

Financing

The study was partially funded by Merck, US