investigators were provided with guidance as described in Table 14 to screen and exclude patients with asthma or mixed asthma. If there was any uncertainty with the diagnosis, investigators would call the country medical advisor or call the global medical monitor to assess the eligibility of the patient. 14: Investigator guidance for screening patients with asthma. Asthma COPD Medical history Asthma is often diagnosed in childhood COPD is diagnosed later in life (>40 (onset early in life) years of age) Past history of allergy, sinusitis, eczema, Allergies and sinusitis are rare in COPD frequent respiratory infections and nasal polyps IgE levels/eosinophil counts could be high because of atopy Many asthmatics are non-smokers or if COPD is frequently associated with smokers likely to be lower significant and long tobacco exposure Family history of asthma usually present Symptoms Characterized by episodic wheeze with Persistent or worsening dyspnea, often chest tightness and dry cough productive chronic cough Symptoms vary from day to day Dyspnea during exercise Symptoms at night/early morning Symptoms are slowly progressive Symptoms are more in the morning and during day Pulmonary Function Tests Asthmatic patients commonly have FEV1/FVC <70% predicted is normal or slightly reduced FEV1/FVC required for the diagnosis of COPD ratio Asthma usually reversible after COPD not fully reversible or irreversible bronchodilator challenge airflow obstruction To ensure the exclusion of patients with asthma or mixed asthma, investigators were required to check the patients’ medical records for any documented history of asthma. This was further validated by the sponsor’s clinical monitor by verifying source documents for patients. Investigators were also expected to discuss patients’ medical history with them to identify any undocumented diagnoses of asthma. Patients with asthma or a suspicion of mixed asthma were therefore excluded on clinical grounds as determined by the investigator. These included onset of symptoms, smoking history, increased IgE levels, increased eosinophils, and history of allergic rhinitis. Furthermore, in Studies A2303 and A2313, >60% of all patients had FEV1 reversibility >12% at baseline (62.9% [1342/2135] in Study A2303 and 65.6% [343/523] in Study A2313). These values are not substantially different from those that have been published for COPD patients.
investigators were provided with guidance as described in Table 14 to screen and exclude patients with asthma or mixed asthma. If there was any uncertainty with the diagnosis, investigators would call the country medical advisor or call the global medical monitor to assess the eligibility of the patient. 14: Investigator guidance for screening patients with asthma. Asthma COPD Medical history Asthma is often diagnosed in childhood (onset early in life) COPD is diagnosed later in life (>40 years of age) Past history of allergy, sinusitis, eczema, frequent respiratory infections and nasal polyps IgE levels/eosinophil counts could be high because of atopy Allergies and sinusitis are rare in COPD Many asthmatics are non-smokers or if smokers likely to be lower Family history of asthma usually present COPD is frequently associated with significant and long tobacco exposure Symptoms Characterized by episodic wheeze with chest tightness and dry cough Symptoms vary from day to day Symptoms at night/early morning Persistent or worsening dyspnea, often productive chronic cough Dyspnea during exercise Symptoms are slowly progressive Symptoms are more in the morning and during day Pulmonary Function Tests Asthmatic patients commonly have normal or slightly reduced FEV1/FVC ratio FEV1/FVC <70% predicted is required for the diagnosis of COPD Asthma usually reversible after bronchodilator challenge COPD not fully reversible or irreversible airflow obstruction To ensure the exclusion of patients with asthma or mixed asthma, investigators were required to check the patients’ medical records for any documented history of asthma. This was further validated by the sponsor’s clinical monitor by verifying source documents for patients. Investigators were also expected to discuss patients’ medical history with them to identify any undocumented diagnoses of asthma. Patients with asthma or a suspicion of mixed asthma were therefore excluded on clinical grounds as determined by the investigator. These included onset of symptoms, smoking history, increased IgE levels, increased eosinophils, and history of allergic rhinitis. Furthermore, in Studies A2303 and A2313, >60% of all patients had FEV1 reversibility >12% at baseline (62.9% [1342/2135] in Study A2303 and 65.6% [343/523] in Study A2313). These values are not substantially different from those that have been published for COPD patients.
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