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

Asthma, Bronchial Clinical Trial

Official title:

A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 Micrograms, 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00385593
• Other study ID #: D5890L00010
• Secondary ID: 2005-005974-64SP
• Status: Terminated
• Phase: Phase 3
• First received: October 6, 2006
• Last updated: November 30, 2010
• Start date: September 2006
• Est. completion date: October 2008

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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 glucocorticosteroids (GCS) treatment or who require and are already on treatment with a combination of inhaled and long-acting B2 agonists (LABA).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 654
• Est. completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 400µg/day of budesonide (or equivalents)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 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.

Study Design

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

Related Conditions & MeSH terms

• Asthma
• Asthma, Bronchial

Intervention

Drug:
• Symbicort (budesonide/formoterol) Turbuhaler

• Conventional treatment

Locations

Country	Name	City	State
Spain	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
Spain	Research Site	Santiago de Compostela
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Severe Asthma Exacerbation	Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral Glucocorticosteroids (GCS) treatment for at least 3 days.	Baseline up to 6 months	No
Secondary	Total Number of Severe Exacerbations	Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral (GCS) treatment for at least 3 days.	Baseline up to 6 months	No
Secondary	Mean Use of as Needed Medication	Mean use of as needed medication during the treatment period	Baseline up to 6 months	No
Secondary	Use of Inhaled Steroids	Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents)	Baseline up to 6 months	No
Secondary	Change in the Asthma Control Questionnaire(ACQ) Score	The ACQ is a 7-point scale with scores ranging from 0 (very well controlled) to 6 (very badly controlled)	Daily 14 days prior to each of visit 2-4	No
Secondary	Peak Expiratory Flow (PEF)	Peak expiratory flow (PEF)	6 months (end of the study)	No