Patients with moderate to very severe chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
Trade Name: Vannair
Product Name: SYMBICORT pMDI 160/4.5
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: Budesonide
CAS Number: 51333-22-3
Other descriptive name: BUDESONI
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent at Visit 1 obtained prior to conducting any study-related procedures including withdrawal of medications. 2. Outpatients; men or women =40 years of age. 3. A current clinical diagnosis of COPD with COPD symptoms for more than 1 year, according to the GOLD guidelines. 4. Current or previous smoker with a smoking history equivalent to 10 or more pack years (1 pack year = 20 cigarettes smoked per day for 1 year). 5. Post-bronchodilator FEV1/forced vital capacity (FVC) 24 hour stay in an observation area in the emergency department or other equivalent facility depending on the country and healthcare system) within 2-52 weeks before Visit 1 (i.e., not within the 14 days prior to Visit 1). A history of an exacerbation treated exclusively with antibiotics will not be considered adequate. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1136 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1136
Exclusion criteria
Exclusion criteria: 1. A history of asthma at or after 18 years of age. 2. Subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure (including significant cor pulmonale), uncontrolled hypertension as defined by the Investigator, or any other relevant cardiovascular disorder as judged by the Investigator. 3. Known homozygous alpha-1 antitrypsin deficiency. 4. Any significant disease or disorder (e.g., gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject’s ability to participate in the study. 5. A history of malignancy (except basal cell carcinoma) within the past 5 years. 6. Active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, or other active pulmonary diseases. 7. Subjects who have needed additions or alterations to their usual maintenance or change in formulation of rescue therapy for COPD due to worsening symptoms within the 14 days prior to Visit 1 and up to Visit 3. 8. CXR (frontal and lateral) with suspicion of pneumonia or other condition/abnormality that will require additional investigation/treatment, or put the subject at risk because of participation in the study. 9. Risk factors for pneumonia: immune suppression (HIV, lupus) or other risk for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson’s disease, myasthenia gravis, etc.). 10. Pneumonia not resolved within 14 days of Visit 1. 11. Moderate or severe COPD exacerbation that has not resolved within 14 days prior to Visit 1 or a moderate or severe COPD exacerbation that occurs between Visit 1 and Visit 2. 12. Long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy in reducing exacerbations with Symbicort pMDI 160/4.5 µg x 2 actuations BID versus formoterol Turbuhaler 4.5 µg x 2 inhalations BID in COPD subjects;Secondary Objective: To compare Symbicort pMDI and formoterol Turbuhaler treatments on the time to the first COPD exacerbation To compare Symbicort pMDI and formoterol Turbuhaler treatments on health status/health-related quality of life To compare Symbicort pMDI and formoterol Turbuhaler treatments on pulmonary function To compare Symbicort pMDI and formoterol Turbuhaler treatments on rescue medication use To compare Symbicort pMDI and formoterol Turbuhaler treatments on nocturnal awakenings To demonstrate the safety of Symbicort pMDI compared to that of formoterol Turbuhaler in subjects with COPD;Primary end point(s): The rate of moderate and severe COPD exacerbations defined as: Worsening of =2 major symptoms or worsening of 1 major symptom together with =1 minor symptom for =2 consecutive days. Moderate exacerbation: treatment of symptoms with systemic corticosteroids (=3 days) and/or antibiotics. Severe exacerbation: symptoms that require hospitalization (including >24 hours in ED/urgent care setting). Major symptoms: • Dyspnea • Increase in sputum volume • Increase in sputum color/purulence Minor symptoms: • Sore throat • Colds (nasal discharge and/or nasal congestion) • Fever without other cause • Increased cough • Increased wheeze;Timepoint(s) of evaluation of this end point: Study Visit: Enrolment W -5 Run-in W -4 Randomization W 0 Treatment W 4, 8, 17 EoT W 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time to first moderate or severe COPD exacerbation • St. George’s Respiratory Questionnaire (SGRQ) • Pre-dose/pre-bronchodilator FEV1 at the study site • Total rescue medication use (average puffs/day) • Nights with awakening due to COPD ;Timepoint(s) of evaluation of this end point: Study Visit: Enrolment W -5 Run-in W -4 Randomization W 0 Treatment W 4, 8, 17 EoT W 26 | — |
Countries
Argentina, Bulgaria, Chile, Czech Republic, European Union, Germany, Mexico, Poland, South Africa, Spain, United States
Contacts
Public Contactinformation centre
AstraZeneca AB
Outcome results
None listed