Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults

Condition(s) targeted: Asthma, Bronchial

Intervention: Symbicort (budesonide/formoterol) Turbuhaler (Drug); Conventional treatment (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: AstraZeneca

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

This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a more general setting in order to assess the real-life impact of introducing this new treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a conventional stepwise treatment regimen according to the investigator's judgement in patients who present with symptoms on inhaled GCS treatment or who require and are already on treatment with a combination of inhaled GCS and LABA.

Official title: A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 mg, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults - a 26-Week, Randomised, Open-Label, Parallel-Group, Multicentre Study. Study SPAIN

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: The primary outcome variable will be time to first severe asthma exacerbations. Exacerbations are considered an appropriate outcome variable by CPMP The definition of a severe asthma exacerbation is based on the same guideline.

Secondary outcome: A secondary objective is to collect safety data for treatment in the two treatment groups in adult patients with persistent asthma

Minimum age: 18 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 (9).

- Prescribed inhaled GCS at a dose of ≥320 µg/day and within the approved label for the

relevant drug during the last 3 months prior to Visit 1.

- Either daily maintenance treatment with both inhaled GCS and long-acting

b2-agonist(LABA) or daily treatment with inhaled GCS alone (i. e. without LABA)

- A history of suboptimal asthma control the month prior to enrolment as judged by the

investigator

- Use of ≥3 inhalations of as needed medication for symptom relief during the last 7

days before enrolment

Exclusion Criteria:

- Previous treatment with Symbicort Single Inhaler;

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

treatment.

- Known or suspected hypersensitivity to study therapy or excipients.

- A history of smoking ≥ 10 pack years.

- Asthma exacerbation requiring change in asthma treatment during the last 14 days prior

to or at Visit 1.

Research Site, A Coruna, Spain

Research Site, Alagon, Spain

Research Site, Alicante, Spain

Research Site, Almoradi, Spain

Research Site, Barcelona, Spain

Research Site, Burgos, Spain

Research Site, Cadiz, Spain

Research Site, Caravaca, Spain

Research Site, Cartagena, Spain

Research Site, Cordoba, Spain

Research Site, Coslada, Spain

Research Site, Dos Hermanas, Spain

Research Site, Elche, Spain

Research Site, Fuencarral, Spain

Research Site, Fuenlabrada, Spain

Research Site, Galdacano, Spain

Research Site, Gallur, Spain

Research Site, Gandia, Spain

Research Site, Getafe, Spain

Research Site, Gijon, Spain

Research Site, Granada, Spain

Research Site, Huelva, Spain

Research Site, Huesca, Spain

Research Site, Idiazabal, Spain

Research Site, Jaen, Spain

Research Site, Lugo, Spain

Research Site, Madrid, Spain

Research Site, Malaga, Spain

Research Site, Mataro, Spain

Research Site, Oviedo, Spain

Research Site, Pamplona, Spain

Research Site, Pinto, Spain

Research Site, Pozuelo de Alarcon, Spain

Research Site, Sagunto, Spain

Research Site, Salamanca, Spain

Research Site, San Juan, Spain

Research Site, San Sebastian, Spain

Research Site, Santander, Spain

Research Site, Santiago de Compostela, Spain

Research Site, Santiago, Spain

Research Site, Sevilla, Spain

Research Site, Terrassa, Spain

Research Site, Valdemoro, Spain

Research Site, Valencia, Spain

Research Site, Valladolid, Spain

Research Site, Vigo, Spain

Research Site, Viladecans, Spain

Research Site, Vilanova, Spain

Research Site, Villabona, Spain

Research Site, Villanueva de la Canada, Spain

Research Site, Vitoria, Spain

Research Site, Zaragoza, Spain

Starting date: September 2006
Ending date: December 2008
Last updated: June 12, 2008