Carnegie Mellon University

BCS Trial Outline

The figure below illustrates the temporal sequence of British Cold Study (BCS) study procedures.  See the table below for a more detailed description of the measures taken during each phase of the study.

BCS-temporal-sequence

Figure 1. Temporal sequence of BCS study activities.  >>Download PowerPoint Slide<<



BCS Measures by Study Phase

Study Phase Measures Collected

1-2 days Pre-Viral Challenge

(Days -1 & -2)*

• Physical exam

• Blood draw:

     o Complete Blood Count (CBC) with differential and serum chemistry;

     o total & viral-specific serum Ab;

     o cotinine

• Clinician reports: Upper Respiratory Illness (URI) signs and symptoms

• Number of tissues used each day

• Nasal wash:

     o total Ab (protein, IgA, & IgE);

     o specific  Ab (IgA)

• Nasal mucus secretion rate

• Questionnaire Sets 1, 2, & 3

End of Quarantine Day 0

Inoculation with Virus (i.e., Viral Challenge)

Quarantine Days 0 through 6

• Clinician reports:  URI signs and symptoms

• Participant reports: URI symptoms

• Nasal wash:  specific IgA

• Ears, nose, and throat (ENT) exam

• Number of tissues used each day

• Nasal mucus secretion rate (Quarantine Days 2-6)

Quarantine Day 6

• Physician and participant ratings of cold severity

4 weeks Post-Challenge

• Blood draw: total and viral-specific serum Ab; cotinine

*Participants in the British Cold Study (in contrast to the three Pittsburgh Cold Studies and the Pittsburgh Mind-Body Center Cold Study) were quarantined in the Common Cold Unit for two days prior to inoculation with the challenge virus.

Study Questionnaire Sets

Questionnaire Set 1

Life Events List
Interpersonal Support Evaluation List
Mood States Scale, Part A

Questionnaire Set 2

Perceived Stress Scale
Fleming & Watts Self Esteem Scale
Mood States Scale, Part B
Social Network Index
Recent Cold History

Questionnaire Set 3

Spheres of Control Scale
Demographics
Physical Activity Questionnaire
Alcohol Consumption Questionnaire
Eating Habits Questionnaire
History and Current Status of Smoking
Sleep