Cystic Fibrosis (CF) Flow Rates Study

This study has been completed.

First Received: October 23, 2008 Last Updated: April 22, 2009 History of Changes

Sponsored by:	Pharmaxis
Information provided by:	Pharmaxis
ClinicalTrials.gov Identifier:	NCT00779077

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:	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:

Genetics Home Reference related topics: cystic fibrosis

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

Keywords provided by Pharmaxis:

device characteristics

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis

Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases

Additional relevant MeSH terms:

Pathologic Processes
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis

Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on September 01, 2009