| Primary | Absolute Change in FEV1 % Predicted From Week 0 to Week 6 | Difference between study arms (discontinue - continue) in the absolute change in FEV1 % predicted from Week 0 to Week 6. | | Posted | | Mean | Standard Deviation | FEV1 % predicted | | Week 0 to Week 6 | | | | ID | Title | Description |
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| OG000 | HS-Discontinue | Discontinuation of current hypertonic saline (HS) therapy Discontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period. | | OG001 | HS-Continue | Continuation of current hypertonic saline (HS) therapy Continuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-0.2± 4.10
- OG0010.1± 3.64
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The non-inferiority test was a priori designed to be conducted on the per-protocol (PP) population. | ANOVA | Adjusted for four dichotomous randomization strata. | <0.0001 | One-sided test for non-inferiority | Median Difference (Final Values) | -0.324 | | | 2-Sided | 95 | -1.3 | 0.6 | | | Direction of difference is Discontinue - Continue. | | Non-Inferiority | The non-inferiority margin is -3. |
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| Secondary | Absolute Change in LCI 2.5 From Baseline to Week 6 | Difference between study arms (discontinue - continue) in the absolute change in LCI 2.5 (Lung Clearance Index) from Baseline (Week 0, if available, or else Week -2) to Week 6. LCI 2.5 is the number of times the volume in the lungs needs to turn over to expel an inert gas. A higher value of LCI 2.5 indicates poorer lung function. | Participants in the per-protocol (PP) population with an acceptable LCI 2.5 measurement at baseline and at Week 6. | Posted | | Mean | Standard Deviation | number of lung volume turnovers | | Baseline (Week 0 or Week -2) to Week 6 | | | | ID | Title | Description |
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| OG000 | HS-Discontinue | Discontinuation of current hypertonic saline (HS) therapy Discontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period. | | OG001 | HS-Continue | Continuation of current hypertonic saline (HS) therapy Continuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%. |
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| Secondary | Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CRISS) From Week 0 to Week 6 | Difference between study arms (discontinue - continue) in the absolute change in respiratory symptoms, as measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CRISS) from Week 0 to Week 6. The Cystic Fibrosis Respiratory Symptoms Daily Diary (CFRSD) asks a participant to state the extent of their 8 respiratory symptoms: difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present 'a great deal' or 'extremely'. A summed score (range from 0-24) is calculated for each participant and converted to a final score with a range of 0 to 100, where the lowest scores indicate improvement of symptoms. Calculation of a score requires responses for at least 7 out of 8 symptoms. | Participants in the per-protocol (PP) population with a CRISS score at Week 0 and Week 6 | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 to Week 6 | | | | ID | Title | Description |
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| OG000 | HS-Discontinue | Discontinuation of current hypertonic saline (HS) therapy Discontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period. | | OG001 | HS-Continue |
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| Secondary | Absolute Change in Respiratory Symptoms, as Measured by CFQ-R Respiratory Domain From Week 0 to Week 6 | Difference between study arms (discontinue - continue) in the absolute change in respiratory symptoms, as measured by the Cystic Fibrosis Questionnaire-Revised Respiratory Domain Score from Week 0 to Week 6. The Cystic Fibrosis Questionnaire - Revised asks participants 6 questions related to respiratory symptoms which are each assigned a score 1-4. The Respiratory Domain Scaled Score is calculated as follows: 100*[{sum of responses}/{number of responses}-1]/3 only if number of responses ≥ 3; otherwise the score is set to missing. The scaled score ranges from 0 to 100 where higher scores indicate improvement of symptoms. | Participants in the per-protocol (PP) population with a score at Week 0 and at Week 6 | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | HS-Discontinue | Discontinuation of current hypertonic saline (HS) therapy Discontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period. | | OG001 | HS-Continue | Continuation of current hypertonic saline (HS) therapy Continuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%. |
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| Secondary | Absolute Change in FEV1 % Predicted From Week -2 to Week 0 | Difference between study arms (discontinue - continue) in the absolute change in FEV1 % predicted from Week -2 to Week 0. | Per-protocol (PP) population | Posted | | Mean | Standard Deviation | % predicted | | Week -2 to Week 0 | | | | ID | Title | Description |
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| OG000 | HS-Discontinue | Discontinuation of current hypertonic saline (HS) therapy Discontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period. | | OG001 | HS-Continue | Continuation of current hypertonic saline (HS) therapy Continuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%. |
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| Secondary | Absolute Change in FEV1 % Predicted From Week 0 to Week 2 | Difference between study arms (discontinue - continue) in the absolute change in FEV1 % predicted from Week 0 to Week 2. | Participants in the per-protocol (PP) population with FEV1 measurements at Week 0 and at Week 2 | Posted | | Mean | Standard Deviation | % predicted | | Week 0 to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | HS-Discontinue | Discontinuation of current hypertonic saline (HS) therapy Discontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period. | | OG001 | HS-Continue | Continuation of current hypertonic saline (HS) therapy Continuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%. |
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| Secondary | Number and Percent of Participants Initiating Acute Antibiotics From Week 0 to Week 6 | Difference between study arms (discontinue - continue) in the percent of subjects initiating acute oral, inhaled or intravenous antibiotics from Week 0 to Week 6. Includes antibiotics initiated for respiratory indications; excludes those taken as part of a chronic cycled regimen or for a UTI, skin infection, etc. | Intent to treat (ITT) population of all randomized participants | Posted | | Count of Participants | | Participants | | Week 0 to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | HS-Discontinue | Discontinuation of current hypertonic saline (HS) therapy Discontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period. | | OG001 | HS-Continue | Continuation of current hypertonic saline (HS) therapy Continuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%. |
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| Secondary | Number and Percent of Participants Hospitalized From Week 0 to Week 6 | Difference between study arms (discontinue - continue) in the percent of subjects hospitalized from Week 0 to Week 6. | Intent-to-treat (ITT) population of all randomized participants. | Posted | | Count of Participants | | Participants | | Week 0 to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | HS-Discontinue | Discontinuation of current hypertonic saline (HS) therapy Discontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period. | | OG001 | HS-Continue | Continuation of current hypertonic saline (HS) therapy Continuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%. |
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| Secondary | Number and Percent of Participants Experiencing Pulmonary Exacerbations From Week 0 to Week 6 | Difference between study arms (discontinue - continue) in the percent of subjects experiencing a pulmonary exacerbation from Week 0 to Week 6. Pulmonary exacerbations defined using Fuchs criteria. | Intent-to-treat (ITT) population of all randomized participants. | Posted | | Count of Participants | | Participants | | Week 0 to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | HS-Discontinue | Discontinuation of current hypertonic saline (HS) therapy Discontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period. | | OG001 | HS-Continue | Continuation of current hypertonic saline (HS) therapy Continuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%. |
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| Secondary | Number and Percent of Participants Experiencing Adverse Events (AEs) From Week 0 to Week 6 | Difference between study arms (discontinue - continue) in the percent of participants with at least one AE from Week 0 to Week 6. Includes serious and non-serious AEs. | Intent-to-treat (ITT) population of all randomized participants. | Posted | | Count of Participants | | Participants | | Week 0 to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | HS-Discontinue | Discontinuation of current hypertonic saline (HS) therapy Discontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period. | | OG001 | HS-Continue | Continuation of current hypertonic saline (HS) therapy Continuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%. |
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| Secondary | Rate of Adverse Events (AEs) From Week 0 to Week 6 Therapy Arms | Comparison of study arms (discontinue/continue) in the rate of AE occurrence (number of events divided by total follow-up weeks in each arm) from Week 0 to Week 6. Includes serious and non-serious AEs. | Intent-to-treat (ITT) population of all randomized participants. | Posted | | Number | | events per week | | Week 0 to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | HS-Discontinue | Discontinuation of current hypertonic saline (HS) therapy Discontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period. | | OG001 | HS-Continue | Continuation of current hypertonic saline (HS) therapy Continuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%. |
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| Secondary | Number and Percent of Participants With Temporary or Permanent Changes From Assigned Therapy Regimen Due to Adverse Event From Week 0 to Week 6 | Difference between study arms (discontinue - continue) in the percent of subjects temporarily or permanently changing their assigned therapy regimen due to an adverse event Week 0 to Week 6 | Intent-to-treat (ITT) population of all randomized participants. | Posted | | Count of Participants | | Participants | | Week 0 to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | HS-Discontinue | Discontinuation of current hypertonic saline (HS) therapy Discontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period. | | OG001 | HS-Continue | Continuation of current hypertonic saline (HS) therapy Continuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%. |
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