Clinical trial NCT00385593: Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Asthma, Bronchial
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-10-09
Enrollment: 654
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility 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 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.

Primary outcomes:
measure: Time to First Severe Asthma Exacerbation
timeFrame: Baseline up to 6 months
Secondary outcomes:
measure: Total Number of Severe Exacerbations
timeFrame: Baseline up to 6 months
measure: Mean Use of as Needed Medication
timeFrame: Baseline up to 6 months
measure: Use of Inhaled Steroids
timeFrame: Baseline up to 6 months
measure: Change in the Asthma Control Questionnaire(ACQ) Score
timeFrame: Daily 14 days prior to each of visit 2-4
measure: Peak Expiratory Flow (PEF)
timeFrame: 6 months (end of the study)
Other outcomes:
Locations:
city: A Coruna
country: Spain
facility: Research Site
city: Alagon
country: Spain
facility: Research Site
city: Alicante
country: Spain
facility: Research Site
city: Almoradi
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Burgos
country: Spain
facility: Research Site
city: Cadiz
country: Spain
facility: Research Site
city: Caravaca
country: Spain
facility: Research Site
city: Cartagena
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Coslada
country: Spain
facility: Research Site
city: Dos Hermanas
country: Spain
facility: Research Site
city: Elche
country: Spain
facility: Research Site
city: Fuencarral
country: Spain
facility: Research Site
city: Fuenlabrada
country: Spain
facility: Research Site
city: Galdacano
country: Spain
facility: Research Site
city: Gallur
country: Spain
facility: Research Site
city: Gandia
country: Spain
facility: Research Site
city: Getafe
country: Spain
facility: Research Site
city: Gijon
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Huelva
country: Spain
facility: Research Site
city: Huesca
country: Spain
facility: Research Site
city: Idiazabal
country: Spain
facility: Research Site
city: Jaen
country: Spain
facility: Research Site
city: Lugo
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Mataro
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
city: Pinto
country: Spain
facility: Research Site
city: Pozuelo de Alarcon
country: Spain
facility: Research Site
city: Sagunto
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: San Juan
country: Spain
facility: Research Site
city: San Sebastian
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Santiago de Compostela
country: Spain
facility: Research Site
city: Santiago
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Terrassa
country: Spain
facility: Research Site
city: Valdemoro
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
city: Vigo
country: Spain
facility: Research Site
city: Viladecans
country: Spain
facility: Research Site
city: Vilanova
country: Spain
facility: Research Site
city: Villabona
country: Spain
facility: Research Site
city: Villanueva de la Canada
country: Spain
facility: Research Site
city: Vitoria
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Carlos Barcina, MD
role: STUDY_DIRECTOR
References: