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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014