Cystic Fibrosis (CF) Flow Rates Study
An Open, Observational, Non-Interventional Study of Inspiratory Flow Rates and Volumes in Subjects With Cystic Fibrosis Inhaling Via a Spirometer With the High Resistance RS01 Dry Powder Inhaler Device in Series
1 other identifier
observational
25
0 countries
N/A
Brief Summary
We wish to measure the inspiratory flow and volumes generated by the subjects inhaling from a spirometer with a high resistance dry powder inhaler in series in subjects with cystic fibrosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2009
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2008
CompletedFirst Posted
Study publicly available on registry
October 24, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedApril 24, 2009
April 1, 2009
1 month
October 23, 2008
April 22, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
inspiratory flow rates
single visit
Secondary Outcomes (1)
inspiratory volumes
single visit
Study Arms (1)
cystic fibrosis
adults and children with cystic fibrosis
Eligibility Criteria
CF 6yrs and above
You may qualify if:
- FEV1 ≥ 30% and \< 90% predicted
You may not qualify if:
- Be considered "terminally ill" or listed for lung transplantation
- Have had a lung transplant
- Have had a significant episode of haemoptysis (\>60 ml) in the three months prior to enrolment
- Have had a myocardial infarction in the three months prior to enrolment
- Have had a cerebral vascular accident in the three months prior to enrolment
- Have had major ocular surgery in the three months prior to enrolment
- Have had major abdominal, chest or brain surgery in the three months prior to enrolment
- Have a known cerebral, aortic or abdominal aneurysm
- Be breast feeding or pregnant
- Be using beta blockers
- Have unstable asthma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Syntaralead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 23, 2008
First Posted
October 24, 2008
Study Start
January 1, 2009
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
April 24, 2009
Record last verified: 2009-04