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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00779077

Enrollment

Registered

2008-10-24

Start date

2009-01-31

Completion date

2009-02-28

Last updated

2009-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

device characteristics

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.

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

6 Years to 50 Years

Healthy volunteers

Inclusion criteria

* CF * FEV1 ≥ 30% and \< 90% predicted

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
inspiratory flow rates	single visit

Secondary

Measure	Time frame
inspiratory volumes	single visit

Outcome results