Changes in Cardiac Function in COPD Patients After Administration of Budesonide/Formoterol (Symbicort®) Versus Placebo
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Budesonide / Formoterol; Placebo
Intervention description: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation. Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).
After 45 minutes , the above measurements will be repeated.; Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).
After 45 minutes , the above measurements will be repeated.
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      To investigate whether Budesonide/Formoterol (Symbicort ®) therapy can improve heart function
      at rest by decreasing lung hyperinflation in patients with COPD (Chronic Obstructive
      Pulmonary Disease).
    

Eligibility criteria:

        Inclusion Criteria:

        Outpatients subjects of either sex between ages 40-80 years, with a diagnosis of COPD. COPD
        will be characterized as the presence of airflow obstruction with an FEV1/FVC < 0.7 (Forced
        Expiratory Volume at one second / Forced Vital Capacity) and a FEV1 (Forced Expiratory
        Volume at one second ) 80% of predicted. All patients must have lung hyperinflation as
        demonstrated by an increase of ≥100 ml after the administration of budesonide/formoterol.
        All patients must have a cigarette smoking history of more than 10 pack-years, and be able
        to perform all the specified procedures as required by the protocol.

        Exclusion Criteria:

          1. Patients with other significant diseases (recent < 6 weeks COPD exacerbation) that
             could place the patient at risk because of participation in the study, or which may
             influence the results of the study or the patients' ability to participate in the
             study.

          2. All patients with a recent (<1 year) history of myocardial infarction, or with a
             recent history of heart failure (NYHA class III and IV, pulmonary edema, or patients
             with cardiac arrhythmias.

          3. Patients on daytime oxygen therapy.

          4. Patients with known active tuberculosis.

          5. Patients with a history of active cancer except for non-metastatic skin cancer.

          6. Patients who have undergone thoracotomy, sternotomy, major cardiopulmonary
             intervention (lung resection, open heart surgery, etc), or other procedure in the 6
             months prior to evaluation likely to cause instability of pulmonary status.

          7. Patients with upper respiratory infection in the past six weeks.