Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2005-005974-64 | |||
| SPAIN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symbicort (budesonide/formoterol) Turbuhaler | Drug | |||
| Conventional treatment | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mean Use of as Needed Medication |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carlos Barcina, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | A Coruña | Spain | ||||
| Research Site |
Not provided
654
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SMART | Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms) |
| FG001 | Conv. Best Practice | Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Mean use of as needed medication during the treatment period |
| Baseline up to 6 months |
| Use of Inhaled Steroids | Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents) | Baseline up to 6 months |
| 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 |
| Peak Expiratory Flow (PEF) | Peak expiratory flow (PEF) | 6 months (end of the study) |
| Alagón |
| Spain |
| Research Site | Alicante | Spain |
| Research Site | Almoradí | Spain |
| Research Site | Barcelona | Spain |
| Research Site | Burgos | Spain |
| Research Site | Cadiz | Spain |
| Research Site | Caravaca | Spain |
| Research Site | Cartagena | Spain |
| Research Site | Coslada | Spain |
| Research Site | Córdoba | Spain |
| Research Site | Donostia / San Sebastian | Spain |
| Research Site | Dos Hermanas | Spain |
| Research Site | Elche | Spain |
| Research Site | Fuencarral | Spain |
| Research Site | Fuenlabrada | Spain |
| Research Site | Galdakao | Spain |
| Research Site | Gallur | Spain |
| Research Site | Gandia | Spain |
| Research Site | Getafe | Spain |
| Research Site | Gijón | Spain |
| Research Site | Granada | Spain |
| Research Site | Huelva | Spain |
| Research Site | Huesca | Spain |
| Research Site | Idiazabal | Spain |
| Research Site | Jaén | Spain |
| Research Site | Lugo | Spain |
| Research Site | Madrid | Spain |
| Research Site | Mataró | Spain |
| Research Site | Málaga | Spain |
| Research Site | Oviedo | Spain |
| Research Site | Pamplona | Spain |
| Research Site | Pinto | Spain |
| Research Site | Pozuelo de Alarcón | Spain |
| Research Site | Sagunto | Spain |
| Research Site | Salamanca | Spain |
| Research Site | San Juan | Spain |
| Research Site | Santander | Spain |
| Research Site | Santiago | Spain |
| Research Site | Santiago de Compostela | Spain |
| Research Site | Seville | 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 Cañada | Spain |
| Research Site | Vitoria-Gasteiz | Spain |
| Research Site | Zaragoza | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SMART | Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms) |
| BG001 | Conv. Best Practice | Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Days | Baseline up to 6 months |
|
|
| |||||||||||||||||||||||||||||
| 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. | Posted | Number | Exacerbations | Baseline up to 6 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Mean Use of as Needed Medication | Mean use of as needed medication during the treatment period | Posted | Mean | Full Range | Inhalations | Baseline up to 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Use of Inhaled Steroids | Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents) | Posted | Mean | Full Range | micrograms | Baseline up to 6 months |
|
| ||||||||||||||||||||||||||||||
| 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) | Posted | Mean | Full Range | Scores on a scale | Daily 14 days prior to each of visit 2-4 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Peak Expiratory Flow (PEF) | Peak expiratory flow (PEF) | Posted | Mean | Full Range | L/min | 6 months (end of the study) |
|
|
Not provided
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SMART | Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms) | 10 | 326 | 0 | 326 | ||
| EG001 | Conv. Best Practice | Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement. | 5 | 326 | 0 | 326 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Epicondylitis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gene Mutation | Congenital, familial and genetic disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Medullary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Irritable Bowel Syndrome | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cerebral Haemorrhage | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bursitis Infective | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
Not provided
The study was prematurely stopped, because it was not possible to recruit the sample size required in the period of time established.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| D019819 | Budesonide |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
|
|
|
|
|