Recruitment

Recruitment Status
Completed
Estimated Enrollment
23

Inclusion Criteria

1 or more hospitalizations for CFPE treatment with intravenous antibiotics within the previous year;
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;
...
1 or more hospitalizations for CFPE treatment with intravenous antibiotics within the previous year;
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
History of consistent sputum production on most occasions;
Not admitted to hospital within the previous 3 weeks;
Body weight greater than or equal to 75% of best measurement in previous 6 months;
Absence of CFPE (i.e., Akron Pulmonary Exacerbation Score <5);
Provision of signed informed-consent to study protocol;

Exclusion Criteria

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

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 Criteria

1 or more hospitalizations for CFPE treatment with intravenous antibiotics within the previous year;
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;
...
1 or more hospitalizations for CFPE treatment with intravenous antibiotics within the previous year;
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
History of consistent sputum production on most occasions;
Not admitted to hospital within the previous 3 weeks;
Body weight greater than or equal to 75% of best measurement in previous 6 months;
Absence of CFPE (i.e., Akron Pulmonary Exacerbation Score <5);
Provision of signed informed-consent to study protocol;

Exclusion Criteria

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

Tracking Information

NCT #
NCT02188758
Collaborators
MaineHealth
Investigators
Not Provided