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Cystic Fibrosis (CF) Flow Rates Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00779077
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : April 24, 2009
Information provided by:

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.

Condition or disease
Cystic Fibrosis

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Official Title: 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
Study Start Date : January 2009
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

cystic fibrosis
adults and children with cystic fibrosis

Primary Outcome Measures :
  1. inspiratory flow rates [ Time Frame: single visit ]

Secondary Outcome Measures :
  1. inspiratory volumes [ Time Frame: single visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CF 6yrs and above

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

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Responsible Party: Dr Brett Charlton, Pharmaxis Identifier: NCT00779077     History of Changes
Other Study ID Numbers: DPM-OSM-403
First Posted: October 24, 2008    Key Record Dates
Last Update Posted: April 24, 2009
Last Verified: April 2009
Keywords provided by Pharmaxis:
device characteristics
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases