Table 2.

Summary description of research protocols and procedures

	Minimal Risk Studies
	PROTOCOL TITLE AND DESCRIPTIONS	REQUIRED PROCEDURES
A	Can some medicine make it harder to learn?	Random assignment to FDA approved medication or placebo
	3 weekends of school-like participation over 1 month to evaluate impact of medication on learning ability.	Allergy skin testing
		Psychological Testing
B	What are the characteristics of adolescents with mild to severe asthma?	8 clinic visits including physical exam, spirometry, and asthma symptom/treatment questionnaires at each visit
	3 years participation to evaluate the characteristics of adolescents with mild to severe asthma.	1 blood test
C	Can a HRCT help in studying asthma?	spirometry test
	One day participation to examine utility of HRTC (High Resolution Computer Tomography) in studying asthma.	HRTC x-ray
D	How to stay healthy when you have asthma?	Random assignment to 1 of 3 levels of intervention: information only, information and 3 home visits from a health care worker, or information and 3 home visits with discussion about asthma medications
	18 month participation to evaluate different methods of helping adolescents control asthma, miss less school, and have fewer health problems
E	How much cortisol and nitric oxide do I have in my body?	24 hr urine collection,
	36 hour hospital observation to evaluate levels of cortisol and nitric oxide.	1 spirometry test
		3 peak flow measures
		nitric oxide levels measured every 4 hours.
	Above minimal risk studies
F	Which of these medicines works better?	Medication change every 4 weeks
	15 week clinical trial comparing two FDA approved medication using a double blind, double dummy placebo crossover design	3 overnight hospital stays
		8 spirometry tests
		8 Nitric Oxide measures
		6 -24hr urine collections
G	How often should asthma medicine be taken?	Random assignment to treatment
	26 week trial to examine fixed versus as needed dosing schedule for established asthma medication.	Medical history
		12 physical exams
		12 spirometry tests
		7 methacholine challenge tests
		1 allergy skin test
		1 electrocardiogram
		1 quality of life questionnaire
		7 urine pregnancy tests
H	How effective are these treatments for asthma over time?	Random assignment to treatment
	5 year clinical trial comparing 2 investigational medications versus placebo	6 comprehensive physical exams
		2 allergy skin tests
		6 Tanner Staging exams
		6 spirometry tests
		2 blood draws
		5 psychological tests
		6 methacholine challenge tests
		2 neuropsychological tests
		6 bone density measurements
I	Does this test help us to understand asthma?	5 clinic visits including spirometry
	4 months participation to evaluate utility of sputum induction findings for asthma treatment.	1 allergy skin test
		2 methacholine challenge tests
		2 sputum inductions