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Cystic Fibrosis (CF) Flow Rates Study

This study has been completed.
Sponsor:
Information provided by:
Pharmaxis
ClinicalTrials.gov Identifier:
NCT00779077
First received: October 23, 2008
Last updated: April 22, 2009
Last verified: April 2009
History of Changes
  Purpose

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
Cystic Fibrosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by Pharmaxis:

Primary Outcome Measures:
  • inspiratory flow rates [ Time Frame: single visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • inspiratory volumes [ Time Frame: single visit ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: January 2009
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
cystic fibrosis
adults and children with cystic fibrosis

  Eligibility

Ages Eligible for Study:   6 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

CF 6yrs and above

Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dr Brett Charlton, Pharmaxis
ClinicalTrials.gov Identifier: NCT00779077     History of Changes
Other Study ID Numbers: DPM-OSM-403
Study First Received: October 23, 2008
Last Updated: April 22, 2009
Health Authority: Australia: TGA

Keywords provided by Pharmaxis:
device characteristics

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013