Please select the outcome measures that correspond to the clinical trial below.
Title: : A Phase III Multicenter, Randomized, Parallel Group, Controlled, Double Blind Study to Investigate the Safety and Efficacy of Inhaled Mannitol Over 12 Months in the Treatment of Bronchiectasis.
Brief Summary: No gold standard therapy exists for clearing mucus from the airways of patients with bronchiectasis. While rhDNase has a proven place in the treatment of cystic fibrosis (CF), it failed to improve Forced expiratory volume in one second (FEV1) in a short-term non-CF bronchiectasis study and has been shown to be detrimental after 6 months therapy in non CF bronchiectasis, moreover it has no proven effect on mucociliary clearance. Hypertonic saline has been shown to have a comparable mode of action to inhaled mannitol, but has yet to be examined as a long term treatment option in bronchiectasis.

The purpose of this study is to examine the efficacy and safety of 52 weeks treatment with inhaled mannitol in subjects with non-cystic fibrosis bronchiectasis. Previous studies with inhaled mannitol have demonstrated improvement in mucociliary clearance; mucus rehydration; improvement in quality of life and respiratory symptoms in patients with bronchiectasis and pulmonary function in cystic fibrosis. The results of this current study in combination with a recently completed 3 month study seek to confirm these early findings and to extend the evidence to support its use as a mucoactive therapy in subjects with bronchiectasis.

We hypothesize that mannitol will improve the overall health and hygiene of the lung through regular and effective clearing of the mucus load. As a consequence of the reduction in mucus load and inflammatory process, the frequency of bronchiectasis related pulmonary exacerbations and the need for exacerbation related antibiotic treatment should fall. Days in hospital and community health care costs are expected to change in line with improvements in respiratory health.

Finally, we plan to demonstrate that inhaled mannitol is safe and well tolerated over a 52 week period. We will test these hypotheses using 400 mg mannitol twice daily (BD) against control.


Options:
A: Change in QOL-B Respiratory Symptoms Score at Day 28 (Baseline to Day 28)
B: Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis? (1 year); Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )? (1 year)
C: Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline (End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.); Ratio of the Percentage Neutrophil Count at End of Treatment Compared to Baseline (End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.); 24-hour Sputum Weight(g) (Baseline and day 28); Slow Vital Capacity (SVC) (Baseline and day 28); Forced Expiratory Volume in 1 Second (FEV1) (Baseline and day 28); Forced Vital Capacity (FVC) (Baseline and day 28); Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%) (Baseline and day 28); Morning Peak Expiratory Flow (PEF) (Last 7 days on treatment); Evening Peak Expiratory Flow (PEF) (Last 7 days on treatment); Bronkotest Diary Card Signs and Symptoms (Last 7 days on treatment); St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) (Baseline and day 28)
D: Rate of Graded Pulmonary Exacerbations (52 weeks)

Answer: D