Microsoft word - p16excldrg_med.doc

Exclusionary Drugs
for BASALT and TALC Common Runin
(Visits 1-3)
Drugs to be withheld throughout the study. Generic Names
Trade Names
Excluded Drug
(may not be inclusive)
(may not be inclusive)
Steroid Medications
flunisolide, fluticasone, mometasone Flovent, Pulmicort, QVAR triamcinolone acetonide Nonsteroidal Antiinflammatory Medications
Bronchodilators
Alupent, Brethine, Bricanyl, Metaprel, 1 week Intermediate-acting inhaled β-agonists albuterol, bitolterol, levalbuterol, Combivent, Donnatal, Scopoderm, Transderm-Scop Xanthine Derivatives
Anti-IgE Therapy
Drugs to be withheld throughout the study. Generic Names
Trade Names
Excluded Drug
(may not be inclusive)
(may not be inclusive)
Cardiac Drugs
Psych or CNS-Related Drugs
isocarboxazid, nialamide, phenelzine, selegiline, toloxatone, tranylcypromine Antibiotics
Drugs Exclusionary for TALC Protocol Only
Drugs/Substances to be withheld prior to Visits 1-3* Drug/substance
Trade Names
Prior to Visits
Antihistamines (chlorpheniramine, desloratadine, Allegra, Allegra-D, Benadryl, Chlor-Trimeton, diphenhydramine, fexofenadine, loratadine and Oral Decongestants (pseudoephedrine and others) Nasal Decongestants (oxymetazoline and others) Methylxanthine-containing food or beverages Anacin, Darvon, Esgic, Excedrin, No-Doz, *These drugs/substances are allowed between visits, but not prior to pulmonary function testing. Exclusionary Medical Conditions for
BASALT and TALC Protocols (may not be
inclusive)
Cardiac arrhythmias (clinically significant) Congenital anomaly, including growth abnormalities (clinically significant) Coronary artery disease (unstable or severe) Eating disorder (e.g. anorexia or bulimia (active disease)) Hypersensitivity to soya lecithin or related food products such as soybean or peanuts (history of)** Lung disease other than asthma (COPD, emphysema, chronic bronchitis, pulmonary embolism, malignancy, cystic fibrosis, among others) Any malignancy other than basal cell skin cancers Myocardial infarction (history within 6 months of enrollment) Skeletal disorders, including osteoporosis and rheumatoid arthritis Substance abuse (including active drug or alcohol abuse) Tuberculosis (history of positive skin test with negative chest x-ray allowed) **These conditions are exclusionary for the TALC protocol only
Inclusion Criteria for BASALT/TALC

• Men and women, 18 years old or older (no upper age limit) • History of physician-diagnosed asthma • Need for daily controller therapy (received prescription for and/or used in past 12 months); or symptoms more than twice a week if not on controller medication. • If on controller medication, must have been on a stable dose for at least 2 weeks prior to • Stable asthma for at least 6 weeks prior to enrollment • Non-smoking (no smoking in the last year, and less than 10-pack year history)

Source: http://aaac.duhs.duke.edu/wysiwyg/downloads/p16excldrg_med.pdf