Recruitment

Recruitment Status
Completed
Estimated Enrollment
23

Inclusion Criterias

FEV1% greater than or equal to 75% of best measurement in previous 6 months;
18<Age>65
Diagnosis of CF confirmed by history of positive chloride sweat test and/or CFTR mutation analysis;
...
FEV1% greater than or equal to 75% of best measurement in previous 6 months;
18<Age>65
Diagnosis of CF confirmed by history of positive chloride sweat test and/or CFTR mutation analysis;
History of consistent sputum production on most occasions;
Body weight greater than or equal to 75% of best measurement in previous 6 months;
1 or more hospitalizations for CFPE treatment with intravenous antibiotics within the previous year;
Provision of signed informed-consent to study protocol;
Absence of CFPE (i.e., Akron Pulmonary Exacerbation Score <5);
Not admitted to hospital within the previous 3 weeks;

Exclusion Criterias

Recent and/or persistent visible blood in sputum (hemoptysis);
Women who are pregnant or lactating;
Subject does not meet Inclusion criteria;
...
Recent and/or persistent visible blood in sputum (hemoptysis);
Women who are pregnant or lactating;
Subject does not meet Inclusion criteria;
Rescue use of oral antibiotics within the previous 3 weeks, defined as antibiotic use for health deterioration rather than chronic suppression

Summary

Conditions
Cystic Fibrosis
Type
Observational
Design
  • Observational Model: Cohort
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Inclusion Criterias

FEV1% greater than or equal to 75% of best measurement in previous 6 months;
18<Age>65
Diagnosis of CF confirmed by history of positive chloride sweat test and/or CFTR mutation analysis;
...
FEV1% greater than or equal to 75% of best measurement in previous 6 months;
18<Age>65
Diagnosis of CF confirmed by history of positive chloride sweat test and/or CFTR mutation analysis;
History of consistent sputum production on most occasions;
Body weight greater than or equal to 75% of best measurement in previous 6 months;
1 or more hospitalizations for CFPE treatment with intravenous antibiotics within the previous year;
Provision of signed informed-consent to study protocol;
Absence of CFPE (i.e., Akron Pulmonary Exacerbation Score <5);
Not admitted to hospital within the previous 3 weeks;

Exclusion Criterias

Recent and/or persistent visible blood in sputum (hemoptysis);
Women who are pregnant or lactating;
Subject does not meet Inclusion criteria;
...
Recent and/or persistent visible blood in sputum (hemoptysis);
Women who are pregnant or lactating;
Subject does not meet Inclusion criteria;
Rescue use of oral antibiotics within the previous 3 weeks, defined as antibiotic use for health deterioration rather than chronic suppression

Locations

South Portland, Maine, 04106
Lebanon, New Hampshire, 03756
South Portland, Maine, 04106
Lebanon, New Hampshire, 03756

Tracking Information

NCT #
NCT02188758
Collaborators
MaineHealth
Investigators
Not Provided