Chronic Obstructive Pulmonary Disease Clinical Trial
— SPACEOfficial title:
A Randomised, Double Blind, Double Dummy, Multicentre Phase III Study Comparing the Efficacy of Budesonide/Formoterol (Symbicort® Forte Turbuhaler®) and Oral Prednisolone + Formoterol (Oxis® Turbuhaler) During Two Weeks, in COPD Patients With an Acute Exacerbation, Followed by Twelve Weeks Open Follow up Period With Budesonide/Formoterol (Symbicort Forte Turbuhaler)
| Verified date | January 2011 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Medical Products Agency |
| Study type | Interventional |
To assess if Symbicort forte Turbuhaler (during two weeks) is as effective as an oral course of prednisolone + Oxis Turbuhaler (during two weeks) for the treatment of an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD).
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | July 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with chronic obstructive pulmonary disease and an acute exacerbation - After the acute treatment a simple pulmonary function test shows a value of 30%-60% of the predicted normal value. - Patients, who, based on the clinical examination after the initial acute treatment, are candidates for a course of oral steroids for the treatment of acute symptoms due to chronic obstructive pulmonary disease Exclusion Criteria: - Diagnosis/history of asthma - Oxygen uptake (saturation) is <92% after the initial acute treatment - A requirement for regular use of oxygen therapy - Regular treatment with any inhaled steroid >1 000 µg/day at study entry Additional inclusion and exclusion criteria will be evaluated by the investigator |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Research Site | Aalbaek | |
| Denmark | Research Site | Aalborg | |
| Denmark | Research Site | Christiansfeld | |
| Denmark | Research Site | Erfurt | |
| Denmark | Research Site | Norager | |
| Denmark | Research Site | Oksbol | |
| Denmark | Research Site | Saeby | |
| Finland | Research Site | Lohja | |
| Finland | Research Site | Pietarsaari | |
| Finland | Research Site | Porvoo | |
| Finland | Research Site | Tammisaari | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Leipzig | |
| Germany | Research Site | Marburg | |
| Norway | Research Site | Fredrikstad | |
| Norway | Research Site | Harstad | |
| Norway | Research Site | Molde | |
| Norway | Research Site | Oslo | |
| Norway | Research Site | Straume | |
| Sweden | Research Site | Akersberga | |
| Sweden | Research Site | Alingsas | |
| Sweden | Research Site | Atvidaberg | |
| Sweden | Research Site | Borlange | |
| Sweden | Research Site | Goteborg | |
| Sweden | Research Site | Hollviken | |
| Sweden | Research Site | Kilafors | |
| Sweden | Research Site | Limhamn | |
| Sweden | Research Site | Lindesberg | |
| Sweden | Research Site | Lulea | |
| Sweden | Research Site | Malmo | |
| Sweden | Research Site | Motala | |
| Sweden | Research Site | Örebro | |
| Sweden | Research Site | Sigtuna | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Trosa | |
| Sweden | Research Site | Tumba | |
| Sweden | Research Site | Uppsala |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Denmark, Finland, Germany, Norway, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Forced Expiratory Volume in one second (FEV1) | |||
| Secondary | Number of patients with treatment failures | |||
| Secondary | Time to first exacerbation | |||
| Secondary | Number of patients developing an exacerbation | |||
| Secondary | Diary cards | |||
| Secondary | Quality of Life | |||
| Secondary | - Adverse Events (AEs) | |||
| Secondary | Serious Adverse Events (SAEs) and Discontinuations due to AEs | |||
| Secondary | Variables will be assessed before and over the 2+12 weeks treatment period |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05102305 -
A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
|
||
| Completed |
NCT01867762 -
An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
| Recruiting |
NCT05562037 -
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
|
N/A | |
| Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
| Completed |
NCT03089515 -
Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
|
N/A | |
| Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
| Recruiting |
NCT05552833 -
Pulmonary Adaptive Responses to HIIT in COPD
|
N/A | |
| Recruiting |
NCT05835492 -
A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
|
||
| Recruiting |
NCT05631132 -
May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?
|
N/A | |
| Completed |
NCT03244137 -
Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
|
||
| Not yet recruiting |
NCT03282526 -
Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease
|
N/A | |
| Completed |
NCT02546700 -
A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 2 | |
| Withdrawn |
NCT04446637 -
Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD
|
Phase 3 | |
| Completed |
NCT04535986 -
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
|
Phase 3 | |
| Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
| Completed |
NCT03256695 -
Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
| Completed |
NCT03295474 -
Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
|
||
| Withdrawn |
NCT04042168 -
Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
| Completed |
NCT03414541 -
Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
| Completed |
NCT02552160 -
DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy
|