Cystic Fibrosis (CF) Flow Rates Study

NCT ID: NCT00779077

Last Updated: 2009-04-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-02-28

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.

Conditions

Cystic Fibrosis

Study Design

• Observational Model Type: COHORT

Study Groups

cystic fibrosis

adults and children with cystic fibrosis

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syntara

INDUSTRY

Sponsor Role: lead

Responsible Party

Pharmaxis

Other Identifiers

DPM-OSM-403

Identifier Type: -

Identifier Source: org_study_id