In case of emergency, please contact:
Investigator
text
Study contact
text
Telephone (daytime)
integer
Telephone (evening/weekends)
integer
Address
text
Diary card
Note: Please complete the web based diary (questionnaire) daily in the evenings. Note: Day 1 will be dosed in the unit. Note: If you take dose differently to the scheduled dose (1 tablet from bottle A and 1 tablet from bottle B) you should contact the site immediately using the contact details on the cover page.
text
Study drug
Note: Do not take bronchodilator prior to clinic visit on Day 14, 21 and 28. Do not perform strenuous exercise 48 hr prior to visit on Day 14, 21 and 28.
integer
Other dosing day
text
day month year
date
00:00-23:59
time
e.g., 1. Note: If you take dose differently to the scheduled dose (1 tablet from bottle A and 1 tablet from bottle B) you should contact the site immediately using the contact details on the cover page.
integer
e.g., 1. Note: If you take dose differently to the scheduled dose (1 tablet from bottle A and 1 tablet from bottle B) you should contact the site immediately using the contact details on the cover page.
integer
Exacerbations
CF Exacerbation event, record.
integer
day month year. Note: If you have an exacerbation, immediately contact the site using the details above. Note: Record your individual symptoms in the itemgroup CHANGES IN HEALTH.
date
00:00-23:59
time
day month year
date
00:00-23:59
time
If Yes, record each antibiotic in the itemgroup OTHER MEDICATIONS.
text
Exacerbation of CF requiring hospitalisation
text
Other medications
Medication record
integer
e.g., Aspirin
text
e.g., Tablet
text
Amount Taken of medication
integer
e.g., Headache
text
day month year
date
00:00-23:59
time
day month year
date
00:00-23:59
time
Changes in health
Changes in health, record.
integer
Diagnosis Only (if known) Otherwise Sign/Symptom. e.g., Headache
text
day month year
date
00:00-23:59
time
day month year
date
00:00-23:59
time
Maximum intensity of event
integer
Daily Respiratory Symptom Diary for Cystic Fibrosis
This item contains the result of clinical outcome assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.
text