Early Intervention in Pulmonary Exacerbation in Cystic Fibrosis

NCT00850551 | Completed

• 1 other identifier: 35243-E/A
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis

Keywords

Early Intervention; Pulmonary Exacerbation; Cystic Fibrosis; Lung Function; Spirometry; Phillips Telemonitor; Home Spirometry; PiKo-6; Home Monitoring

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (1)

• 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.

  6 months

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Usual Care

Other: Early Intervention

Intervention

OTHER

Twice weekly home spirometry and symptom assessment

Other: Early Intervention

Interventions

Early Intervention OTHER

Twice a week home spirometry and symptom assessment

Also known as: Piko-6, Philips Telemonitor

Intervention; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Christopher H Goss, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 23, 2009
• First Posted: February 25, 2009
• Study Start: January 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 1, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)