TABLE 6.
Respiratory parametersb | Effects with nebulized administration of CMS at dose of: |
Effects with i.v. infusion of 150 mg of CBAc |
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2 million IU |
4 million IU |
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Predose | Postdosed | Predose | Postdosed | Predose | Postdosed | |
FEV1e | 2.0 ± 0.65 | 1.9 ± 0.65 | 2.0 ± 0.61 | 2.1 ± 0.64f | 2.1 ± 0.62 | 2.1 ± 0.62 |
FVCe | 3.6 ± 0.85 | 3.5 ± 0.94 | 3.9 ± 0.87 | 3.8 ± 0.93f | 3.9 ± 0.78 | 3.9 ± 0.88 |
MIPe | 155 ± 64 | 151 ± 44 | 160 ± 40 | 161 ± 33 | 148 ± 39 | 153 ± 36 |
MEPe | 157 ± 56 | 157 ± 55 | 158 ± 30 | 166 ± 38 | 152 ± 29 | 164 ± 30 |
eGFRg | 127 ± 18 | 121 ± 20h | 133 ± 22 | 121 ± 37 | 145 ± 22 | 127 ± 31h |
Data represented as mean ± SD (n = 6).
FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; MIP, minimum inspiratory pressure; MEP, maximum expiratory pressure.
For lung function parameters, n = 5, as subject 2 did not undergo lung function tests since he presented with hemoptysis.
One to two hours postadministration for lung function test; 12 h postadministration for eGFR.
No statistically significant difference between pre- and postdose measurements for FEV1, FVC, MIP, and MEP.
Due to time constraints in the lung function laboratory, n = 5, as FEV1 and FVC could not be carried out for subject 2.
No statistically significant difference was found between pre- and postdose measurements for eGFR following nebulized CMS delivery. A statistically significant difference was found between pre- and postdose measurements for eGFR following i.v. CMS delivery.
n = 4 for nebulized 2 million IU CMS and n = 5 for i.v. 150 mg of CBA.