Page 1 of 5. Bronchial Asthma IDGN-BA-A16 I. INCLUSION AND EXCLUSION CRITERIA
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1 Page 1 of 5 Subject's initials: (in Hebrew) פרטי משפחה INCLUSION CRITERIA I. INCLUSION AND EXCLUSION CRITERIA 1. Subject is diagnosed with Asthma according to: Yes No a. Presence of symptoms of airflow obstruction (2 or more of cough, wheezing, dyspnea). b. Airflow obstruction is at least partially reversible (demonstrated by spiromentry at any time - FEV1 increased by >15% following β-agonist inhalation) or evidence of bronchial hyperresponsiveness by metacholine challenge (demonstrated by PC20<8µg). 2. Age > 12 years. 3. Subject has less than 3 pack-years of smoking. 4. All 4 grandparents are of Ashkenazi Jewish origin as declared by the subject. 5. Subject or subject s legal representative has signed the informed consent form. EXCLUSION CRITERIA 1. Subject is diagnosed with any of the following list of Asthma differential diagnoses: a. Obstructions involving large airways: foreign body in trachea or bronchus; vocal cord dysfunction; vascular rings or laryngeal webs; laryngotracheomalacia, tracheal stenosis or bronchostenosis; enlarged lymph nodes or tumor. b. Obstructions involving small airways: viral bronchiolitis or obliterative bronchiolitis; cystic fibrosis; bronchopulmonary dysplasia. c. Other causes: recurrent cough not due to asthma (i.e. secondary to drugs such as angiotensin-converting enzyme [ACE] inhibitors); aspiration from swallowing mechanism dysfunction or gastroesophgeal reflux; chronic obstructive pulmonary disease (chronic bronchitis or emphysema); congestive heart failure; pulmonary embolism; pulmonary infiltration with eosinophilia; vasculitis involving the lungs and airways; post-transplant patients. 2. Subject is a known carrier of a blood transmitted infectious disease or suffers from conditions in which phlebotomy is contra-indicated. Yes No Subject is eligible for the study, if all INCLUSION criteria are YES and all EXCLUSION criteria are NO. INVESTIGATOR S STATEMENT CONCERNING DATA VERIFICATION I have verified the data entered in the Case Report Form and have determined that it is complete, accurate and compatible with the source documents. / / Investigator s name (printed) Investigator s signature Day Month Year Where appropriate mark like this (not like this )
2 Page 2 of 5 II. DEMOGRAPHICS 1. Sex: Male 4. Year of immigration: Female 5. Height*: cm 2. Year of birth: 6. Weight*: kg 3. Country of birth: * If measurements cannot be carried out, subject s declaration is sufficient. III. FAMILY HISTORY 1. Mother 2. Father Country of birth Country of birth 1.1 Mother: 2.1 Father: 1.2 Grandfather: 2.2 Grandfather: 1.3 Grandmother: 2.3 Grandmother: 3. Blood relatives: 3.1 Specify total number of siblings (including patient): 3.2 For close family members known to suffer from the following conditions, please answer the questions regarding their medical history: Migraine or Childhood onset Adult onset Skin Allergic recurrent asthma (<=12 yrs.) asthma atopy/eczema rhinitis headaches Mother Father Sib 1 Sib 2 Sib 3 Child
3 Page 3 of 5 IV. CLINICAL CHARACTERISTICS 1. Age at diagnosis or onset of symptoms (the earliest of the two): 2. Diagnosis was made by (mark one or both): a. FEV1 improvement of more than 15% after inhalation of a β adrenergic agonist. b. Bronchial hyperresponsiveness demonstrated by a PC20<8µ gram of methacholine. 3. Last abnormal pulmonary function tests: a. FEV1% Pre-beta agonists b. FEV1% Post-beta agonists Regarding asthma severity (before treatment, excluding inhaled short acting agents): 4. Symptoms occur at a frequency of: a. 2 episodes per week or less b. More than 2 episodes per week but not daily c. Daily 5. Do exacerbations limit daily activity? Yes No 6. Does the patient use inhaled short acting β-agonists daily? 7. Specify the number of daily puffs of inhaled short acting agent: 8. The frequency of night-time symptoms is (mark only one): a. 2 episodes per month or less b. More than 2 episodes per month but less than 1 episode per week c. More than 1 episode per week d. Almost every night
4 Page 4 of 5 IV. CLINICAL CHARACTERISTICS (cont.) 9. Is PEF / FEV1% normal between attacks? Yes No Unknown 10. Can a precipitating / aggravating factor be identified? * *If yes, specify (mark as many as appropriate): a. Environmental indoor (e.g. mites) b. Exercise c. Infection d. Occupational chemicals / allergens e. Emotions f. Drugs (including aspirin and NSAIDs) g. Food / food additives / preservatives h. Seasonal changes i. Changes in weather j. Menses / pregnancy k. Other, specify: Other: 11. Does the patient suffer from allergic rhinitis / chronic sinusitis? 12. Does the patient suffer from frequent skin allergies / eczema? 13. Does the patient suffer from migraine headaches?
5 Page 5 of 5 V. MEDICATIONS 1. Regarding long-term therapy (if relevant), specify the drug / drug combination that gives the patient the best improvement / control of the disease: Short-acting agents only Long-acting β agonist Inhaled corticosteroids at a low-medium dose Inhaled corticosteroids at a high dose A leukotrein modifier Theophylline Systemic steroids-intermittently* Systemic steroids-continuously** *If treated intermittently with systemic steroids, specify the number of courses given over last year: **If treated continuously, specify the average prednisone equivalent dose:
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Nasal and Sinus Disorders Chronic Nasal Congestion When nasal obstruction occurs without other symptoms (such as sneezing, facial pressure, postnasal drip etc.) then a physical obstruction might be the