DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



SYMPHONIE - A Comparison of Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Budesonide/formoterol Turbuhaler (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca France Medical Director, MD, Study Director, Affiliation: AstraZeneca

Summary

The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma.

Clinical Details

Official title: A Comparison of Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26-week, Randomised, Open, Parallel Group Multicentre Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to first severe asthma exacerbation

Secondary outcome: Number of asthma exacerbations, Mean use of as-needed medication, Prescribed asthma medication, Asthma Control Questionnaire, Satisfaction with Asthma Treatment Questionnaire, Safety: Serious Adverse Events and discontinuations due to adverse events

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Minimum of 3 months history of asthma, diagnosed according to the American Thoracic

Society (ATS) definition. Prescribed inhaled GCS at a dose of ³400 µg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1. Exclusion Criteria:

- Use of any b-blocking agent, including eye-drops, Use of oral GCS as maintenance

treatment, A history of smoking ³ 10 pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).

Locations and Contacts

Research Site, Abbeville, France

Research Site, Agen, France

Research Site, Ajaccio, France

Research Site, Albi, France

Research Site, Ales, France

Research Site, Amberieu En Bugey, France

Research Site, Amiens, France

Research Site, Angers, France

Research Site, Angouleme, France

Research Site, Apt, France

Research Site, Arles, France

Research Site, Aubagne, France

Research site, Avignon, France

Research Site, Avrille, France

Research Site, Bastia, France

Research Site, Bayonne, France

Research Site, Bethune, France

Research Site, Beziers, France

Research Site, Biarritz, France

Research Site, Blois, France

Research Site, Bois Guillaume, France

Research Site, Bordeaux, France

Research Site, Boulogne Billancourt, France

Research Site, Bourgoin Jallieu, France

Research Site, Brest, France

Research Site, Briey, France

Research Site, Bron, France

Research Site, Cabestany, France

Research Site, Cachan, France

Research Site, Caen, France

Research Site, Cagnes Sur Mer, France

Research Site, Cambrai, France

Research Site, Carcassonne, France

Research Site, Castelnau Le Lez, France

Research site, Challans, France

Research Site, Chalons En Champagne, France

Research Site, Champs Sur Marne, France

Research Site, Charleville Mezieres, France

Research Site, Chelles, France

Research Site, Cherbourg Octeville, France

Research Site, Chevilly Larue, France

Research Site, Choisy Le Roi, France

Research site, Cholet, France

Research Site, Colmar, France

Research Site, Cornebarrieu, France

Research Site, Courbevoie, France

Research Sites, Creteil, France

Research Site, Denain, France

Research Site, Dieppe, France

Research Site, Dijon, France

Research Site, Dole, France

Research Site, Epernay, France

Research Site, Epinal, France

Research Site, Ermont, France

Research Site, Etampes, France

Research Site, Fecamp, France

Research Site, Forbach, France

Research Site, Gournay Sur Marne, France

Research Site, Grenoble, France

Research Site, Hagondange, France

Research Site, Hazebrouck, France

Research Site, Henin Beaumont, France

Research Site, Herblay, France

Research Site, Hyeres, France

Research Site, Issy Les Moulineaux, France

Research Site, Joigny, France

Research Site, Juan Les Pins, France

Research Site, La Roche Sur Yon, France

Research site, La Rochelle, France

Research Site, La Teste De Buch, France

Research Site, Lagardelle Sur Leze, France

Research Site, Le Havre, France

Research Site, Le Puy En Velay, France

Research site, Lens, France

Research Site, Les Mureaux, France

Research Site, Libourne, France

Research Site, Lille, France

Research site, Limoges, France

Research site, Loudeac, France

Research site, Luneville, France

Research Site, Lyon, France

Research Site, Marcq En Baroeul, France

Additional Information

Starting date: September 2004
Last updated: January 21, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017