Early Intervention in Pulmonary Exacerbation in Cystic Fibrosis

This study has been completed.
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Chris Goss, University of Washington
ClinicalTrials.gov Identifier:
NCT00850551
First received: February 23, 2009
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

This study will be performed at the University of Washington. Forty subjects with Cystic Fibrosis will be enrolled, with 20 randomized into the usual care arm and 20 randomized into the intervention arm. All subjects will be enrolled for 6 months and have 3 study visits. One at baseline, midpoint, and final. The intervention arm subjects may have more study visits depending on their respiratory symptoms.

The intervention arm subjects will perform home spirometry twice a week with a PiKo-6 hand held spirometer. They will also have a home-based telemonitoring system connected to their phone line. They will be prompted twice a week to answer questions regarding their health via the telemonitor.

Subjects who are not able to utilize the home-based telemonitoring system will answer the questions regarding their health via the internet from their home computer.

If the subject's spirometry falls by greater than 10% from baseline or the CF respiratory symptoms change in 3 or more of the 8 respiratory symptoms captured by the telemonitor questionnaire, the subject will be called by the research staff and clinically evaluated by the study PIs within three days.

The usual care subjects will continue with their routine care at the University of Washington CF Clinic.


Condition Intervention
Cystic Fibrosis
Other: Early Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Early Intervention in Pulmonary Exacerbation in Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Assess the feasibility of the use of home spirometry and home symptom assessment on the diagnosis of acute pulmonary exacerbation in adult patients with mild to moderate CF lung disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the impact of the use of home spirometry, home symptom assessment and a protocolized approach to treatment of acute pulmonary exacerbation compared to usual care. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: January 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Usual Care
Other: Early Intervention
Twice a week home spirometry and symptom assessment
Other Names:
  • Piko-6
  • Philips Telemonitor
Intervention
Twice weekly home spirometry and symptom assessment
Other: Early Intervention
Twice a week home spirometry and symptom assessment
Other Names:
  • Piko-6
  • Philips Telemonitor

Detailed Description:

The study design is a single center, randomized non-blinded controlled clinical trial comparing usual care to a program of early identification and treatment of pulmonary exacerbation in adults with CF. Forty subjects will be enrolled a at the University of Washington with 20 subjects randomized into the usual care arm, and 20 randomized into the intervention arm.

Usual care is defined as the regular quarterly CF visits with acute visits triggered by calls from the patient to the clinic. Neither home assessment of spirometry or standardized home symptom assessment are a component of usual care. Treatment of a pulmonary exacerbation will be based on a standard protocol employing a standard definition and treatment regimen. This study will employ current standardized CF pulmonary exacerbation orders used at the University of Washington. Usual care arm subjects will have 3 study visits at baseline, midpoint, and final, over a period of 6 months.

The early intervention protocol will employ twice a week assessment of home spirometry and CF respiratory symptoms; we will employ a home based monitoring system from Philips called the Philips Remote Patient Monitoring system (TeleStation). The home monitoring system is connected to the patient's phone line; this system is currently used in clinical practice in the care of patients with diabetes and heart failure.

Subjects who do not have a home phone line will answer the CF respiratory questions via the internet from their home computer.

The home spirometry will be done using a PiKo-6 hand held spirometer up to 84 spirometry values. If the subject's spirometry falls by greater than 10% from baseline or the CF respiratory symptoms change in 3 or more of the 8 respiratory symptoms captured in the questionnaire, the subject will be called by the research staff and clinically evaluated by the study PIs within three days. This evaluation will include a history and physical exam along with repeat spirometry at the clinic. The intervention arm subjects will have 3 study visits at baseline, midpoint, and final, over a period of 6 months. They may have additional study visits depending on their respiratory symptoms or exacerbations during the 6 month study period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female at least 18 years old
  • Confirmed diagnosis of cystic fibrosis
  • Chronically colonization wtih Pseudomonas defined by positive sputum or lower airway cultures on 2 or more occasions in any 12 month period
  • Ability to participate in an interview and administration of questionnaire lasting 60 minutes
  • Clinically stable without IV antibiotic treatment for a pulmonary exacerbation in the prior 2 weeks
  • Ability to perform spirometry
  • Have a home telephone line or home computer with internet connection
  • Written informed consent

Exclusion Criteria:

  • Colonization with burkholderia cepacia complex
  • Confirmed diagnosis of allergic bronchopulmonary aspergillosis as defined by the CFF guidance document
  • Currently receiving antimicrobial therapy to treat non-tuberculous mycobacterium
  • History of prior solid organ transplant
  • Inability to speak and read the English language well enough to complete questionnaire
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850551

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Cystic Fibrosis Foundation
Investigators
Principal Investigator: Christopher H Goss, MD University of Washington
  More Information

No publications provided

Responsible Party: Chris Goss, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00850551     History of Changes
Other Study ID Numbers: 35243-E/A
Study First Received: February 23, 2009
Last Updated: June 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Early Intervention
Pulmonary Exacerbation
Cystic Fibrosis
Lung Function
Spirometry
Phillips Telemonitor
Home Spirometry
PiKo-6
Home Monitoring

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 August 21, 2014