Comparing the Efficacy of Symbicort® pMDI and Formoterol Turbuhaler in Reducing Exacerbations in Patients With Cronic Obstructive Pulmonary Disease
Condition: COPD Patients
MeSH terms: Lung Diseases, Obstructive
Intervention: Symbicort; Formoterol turbohaler; Placebo for Symbicort pMDI; Placebo for Formoterol Turbohaler
Intervention description: Budesonide/formoterol pMDI, 160/4.5 μg x 2 actuations BID, for oral inhalation, 120 doses; Formoterol Turbuhaler 4.5 μg x 2 actuations BID, for oral inhalation, 60 doses; pMDI, aerosol for oral inhalation, placebo, 120 doses; PLacebo powder for oral inhalation, 60 doses
Intervention MeSH terms: Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2026.0
Sex: All
Minimum age: 40 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: COPD, turbuhaler, pMDI

Summary:

      Comparing the efficacy of Symbicort® pMDI and Formoterol Turbuhaler in reducing exacerbations
      in patients with Chronic Obstructive Pulmonary Disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

        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) <0.7 (70%) and FEV1 ≤70% of
        predicted normal (PN) value.

        6. Documented use of a short-acting inhaled bronchodilator (β2-agonists or
        anticholinergics) as rescue medication within 6 months prior to study start.

        7. A score of ≥2 on the modified medical research council (MMRC) dyspnea scale. 8.
        Documented history of ≥1 moderate or severe COPD exacerbation(s) that required treatment
        with systemic (oral, IM, IV) corticosteroids (a minimum 3 day course of an oral
        corticosteroid treatment or single depot corticosteroid injection), or hospitalization
        (defined as an inpatient stay or >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.

        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.

         13. Subjects who are currently in the intensive rehabilitation phase or scheduled to begin
             new participation (intensive rehabilitation phase) in a pulmonary rehabilitation
             program during the study or have started a new pulmonary rehabilitation program within
             60 days of Visit 1. Subjects in the maintenance phase of pulmonary rehabilitation
             program are not excluded.

         14. Treatment with oral, parenteral, or intra-articular corticosteroids within 4 weeks
             prior to Visit 1.

         15. Omalizumab or any other monoclonal or polyclonal antibody therapy taken for any reason
             within 6 months prior to Visit 1.