Asthma Clinical Trial
Official title:
A Comparison of the Efficacy 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 Adolescents and Adults - a 26 Weeks, Randomised, Open-label, Parallel-group, Multicentre Study
| Verified date | January 2011 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Portugal: National Pharmacy and Medicines Institute |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 1000 |
| Est. completion date | December 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
Inclusion Criteria: - - Diagnosis of asthma ³ 3 months - Prescribed daily use of glucocorticosteroids at a dose > 320 mcg/ day for at least 3 months prior to Visit 1 Exclusion Criteria: - Smoking history > 10 pack-years - Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion - Any significant disease or disorder that my jeopardize the safety of the patient. Additional inclusion and exclusion criteria will be evaluated by the investigator. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Chile | Research Site | Quillota | |
| Chile | Research Site | Valparaiso | |
| Croatia | Researh Site | Dubrovnik | |
| Croatia | Research Site | Split | |
| Croatia | Research Site | Zagreb | |
| Czech Republic | Research Site | Brno | |
| Czech Republic | Research Site | Hradec Králové | |
| Czech Republic | Research Site | Jihlava | |
| Czech Republic | Research Site | Litomice | |
| Czech Republic | Research Site | Ostrava | |
| Czech Republic | Research Site | Praha | |
| Czech Republic | Research Site | Prostijov | |
| Czech Republic | Research Site | Strakonice | |
| Greece | Research Site | Ahens | |
| Greece | Research Site | Alexandroup | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Kavala | |
| Iceland | Research Site | Akureyri | |
| Iceland | Research Site | Reykjavik | |
| Latvia | Research Site | Daugavpils | |
| Latvia | Research Site | Riga | |
| Latvia | Research Site | Rigas raj | |
| Lithuania | Research Site | Kaunas | |
| Lithuania | Research Site | Klaipeda | |
| Lithuania | Research Site | Vilnius | |
| Portugal | Research Site | Aveiro | |
| Portugal | Research Site | Coimbra | |
| Portugal | Research Site | Coviha | |
| Portugal | Research Site | Lisboa | |
| Portugal | Research Site | Porto | |
| Portugal | Research Site | Setubal | |
| Portugal | Research Site | Vila Nova de Gaia | |
| Slovakia | Research Site | Banská Bystrica | |
| Slovakia | Research Site | Bardejov | |
| Slovakia | Research Site | Bratislava | |
| Slovakia | Research Site | Hlohovec | |
| Slovakia | Research Site | Kosice | |
| Slovakia | Research Site | Liptovský Hrádok | |
| Slovakia | Research Site | Malacky | |
| Slovakia | Research Site | Nitra Zobor | |
| Slovakia | Research Site | Partizánske | |
| Slovakia | Research Site | Revúca | |
| Slovakia | Research Site | Senec | |
| Slovakia | Research Site | Topostany | |
| Slovakia | Research Site | Zilina | |
| Slovenia | Research Site | Celje | |
| Slovenia | Research Site | Golnik | |
| Slovenia | Research Site | Kamnik | |
| Slovenia | Research Site | Koper | |
| Slovenia | Research Site | Litija | |
| Slovenia | Research Site | Ljubljana | |
| Slovenia | Research Site | Murska Sobota | |
| Slovenia | Research Site | Nova Gorica |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Chile, Croatia, Czech Republic, Greece, Iceland, Latvia, Lithuania, Portugal, Slovakia, Slovenia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to first severe asthma exacerbation | |||
| Secondary | Number of asthma exacerbations | |||
| Secondary | Mean use of as-needed medication | |||
| Secondary | Prescribed asthma medication | |||
| Secondary | Asthma Control Questionnaire | |||
| Secondary | Asthma related costs (direct asthma medication, direct non-medication costs and indirect costs) | |||
| Secondary | Safety: Serious Adverse Events and discontinuations due to adverse events | |||
| Secondary | All variables assessed over the 6 months treatment period |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04410523 -
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
|
Phase 2 | |
| Completed |
NCT04624425 -
Additional Effects of Segmental Breathing In Asthma
|
N/A | |
| Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
N/A | |
| Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
| Recruiting |
NCT03694158 -
Investigating Dupilumab's Effect in Asthma by Genotype
|
Phase 4 | |
| Terminated |
NCT04946318 -
Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma
|
Phase 2 | |
| Completed |
NCT04450108 -
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
|
N/A | |
| Completed |
NCT03086460 -
A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)
|
Phase 2 | |
| Completed |
NCT01160224 -
Oral GW766944 (Oral CCR3 Antagonist)
|
Phase 2 | |
| Completed |
NCT03186209 -
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
|
Phase 3 | |
| Completed |
NCT02502734 -
Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
|
Phase 3 | |
| Completed |
NCT01715844 -
L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics
|
Phase 1 | |
| Terminated |
NCT04993443 -
First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036
|
Phase 1 | |
| Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
| Recruiting |
NCT06033833 -
Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
|
Phase 2 | |
| Completed |
NCT03257995 -
Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.
|
Phase 2 | |
| Completed |
NCT02212483 -
Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
|
N/A | |
| Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
| Withdrawn |
NCT01468805 -
Childhood Asthma Reduction Study
|
N/A | |
| Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|