| 1.1 Change in FEV1 (% predicted) |
5 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 1.1.1 At 2 to 4 weeks (all participants) |
4 |
246 |
Mean Difference (IV, Fixed, 95% CI) |
3.30 [0.71, 5.89] |
| 1.1.2 At 2 to 4 weeks (participants aged 14 years and over) |
2 |
205 |
Mean Difference (IV, Fixed, 95% CI) |
4.15 [1.14, 7.16] |
| 1.1.3 At 2 to 4 weeks (children FEV1 > 80% predicted) |
1 |
20 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.42 [‐7.45, 6.61] |
| 1.1.4 At 12 weeks |
1 |
149 |
Mean Difference (IV, Fixed, 95% CI) |
4.10 [‐0.08, 8.28] |
| 1.1.5 At 24 weeks |
1 |
140 |
Mean Difference (IV, Fixed, 95% CI) |
5.37 [1.03, 9.71] |
| 1.1.6 At 36 weeks |
1 |
134 |
Mean Difference (IV, Fixed, 95% CI) |
3.63 [‐1.56, 8.82] |
| 1.1.7 At 48 weeks |
1 |
134 |
Mean Difference (IV, Fixed, 95% CI) |
2.31 [‐2.72, 7.34] |
| 1.1.8 24 hours after single dose |
1 |
36 |
Mean Difference (IV, Fixed, 95% CI) |
0.30 [‐3.48, 4.08] |
| 1.2 Change in FVC (% predicted) |
3 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 1.2.1 At 2 to 4 weeks |
3 |
225 |
Mean Difference (IV, Fixed, 95% CI) |
1.07 [‐1.63, 3.78] |
| 1.2.2 At 12 weeks |
1 |
141 |
Mean Difference (IV, Fixed, 95% CI) |
4.56 [0.79, 8.33] |
| 1.2.3 At 24 weeks |
1 |
140 |
Mean Difference (IV, Fixed, 95% CI) |
3.64 [0.17, 7.11] |
| 1.2.4 At 36 weeks |
1 |
134 |
Mean Difference (IV, Fixed, 95% CI) |
3.40 [‐0.82, 7.62] |
| 1.2.5 At 48 weeks |
1 |
134 |
Mean Difference (IV, Fixed, 95% CI) |
2.76 [‐1.09, 6.61] |
| 1.3 Mean change in FEV0.5 (mL) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.3.1 At 48 weeks |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.4 Mean change in FEV0.75 (L) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 1.4.1 12 weeks |
1 |
150 |
Mean Difference (IV, Fixed, 95% CI) |
0.02 [‐0.03, 0.07] |
| 1.4.2 24 weeks |
1 |
150 |
Mean Difference (IV, Fixed, 95% CI) |
0.02 [‐0.04, 0.08] |
| 1.4.3 36 weeks |
1 |
150 |
Mean Difference (IV, Fixed, 95% CI) |
0.04 [‐0.01, 0.09] |
| 1.4.4 48 weeks |
1 |
150 |
Mean Difference (IV, Fixed, 95% CI) |
0.01 [‐0.04, 0.06] |
| 1.5 LCI |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.5.1 At 4 weeks |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.6 LCI change from baseline |
2 |
190 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.60 [‐1.00, ‐0.19] |
| 1.6.1 At 12 months |
2 |
190 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.60 [‐1.00, ‐0.19] |
| 1.7 Radiolabelled isotope clearance (%) |
3 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 1.7.1 At 60 mins |
3 |
68 |
Mean Difference (IV, Fixed, 95% CI) |
6.14 [2.56, 9.72] |
| 1.8 Mucociliary clearance measured as area under the curve |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 1.8.1 Single dose |
2 |
44 |
Mean Difference (IV, Fixed, 95% CI) |
‐212.06 [‐271.64, ‐152.48] |
| 1.9 Change in mucocilliary clearance rate (% clearance) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.9.1 At 4 weeks |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.10 Exercise capacity (using a subjective visual analogue score) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 1.10.1 At Week 1 |
1 |
52 |
Mean Difference (IV, Fixed, 95% CI) |
0.88 [0.19, 1.57] |
| 1.10.2 At Week 2 |
1 |
52 |
Mean Difference (IV, Fixed, 95% CI) |
1.01 [0.18, 1.84] |
| 1.11 Quality of life (change from baseline) |
4 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 1.11.1 CFQ parent |
3 |
365 |
Mean Difference (IV, Fixed, 95% CI) |
1.62 [‐1.69, 4.92] |
| 1.11.2 CFQ 14+ |
1 |
91 |
Mean Difference (IV, Fixed, 95% CI) |
7.77 [1.86, 13.68] |
| 1.11.3 SF36 |
1 |
91 |
Mean Difference (IV, Fixed, 95% CI) |
2.84 [‐7.90, 13.58] |
| 1.11.4 CFQ‐R respiratory domain at 4 weeks |
1 |
20 |
Mean Difference (IV, Fixed, 95% CI) |
7.40 [‐2.45, 17.25] |
| 1.12 Feeling of cleared chest (using a subjective visual analogue scale) |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 1.12.1 At up to Week 1 |
2 |
72 |
Mean Difference (IV, Fixed, 95% CI) |
0.97 [0.35, 1.60] |
| 1.13 Average number of pulmonary exacerbations |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.13.1 Number requiring antibiotics |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.13.2 Number of visits not requiring antibiotics |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.14 Average number of hospital admissions per participant |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.14.1 At 48 weeks |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.15 Mean adherence rate |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 1.16 Change in log10 colony forming units (CFU)/g from baseline at final visit |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.16.1 P. aeruginosa
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.16.2 S. aureus
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.17 Mean time (years) to first detection of CF pathogens |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.17.1 First detection of S aureus
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.17.2 First detection of H influenzae
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.17.3 First isolation of P aeruginosa
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.18 Adverse events: acute fall in lung function |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.18.1 Acute fall in FEV₁ % predicted |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.18.2 Acute fall in FEV₁ mL |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 1.19 Adverse events 2 to 4 weeks |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 1.19.1 Any adverse event |
1 |
23 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.81 [0.59, 1.10] |
| 1.19.2 Cough |
2 |
75 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.80 [0.41, 1.58] |
| 1.19.3 Pharyngitis |
2 |
75 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.08 [0.36, 26.35] |
| 1.19.4 Chest tightness |
1 |
52 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.79 [0.12, 65.38] |
| 1.19.5 Haemoptysis |
1 |
52 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.93 [0.21, 4.17] |
| 1.19.6 Wheezing |
1 |
23 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.22 [0.01, 4.93] |
| 1.19.7 Nasal congestion |
1 |
23 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.43 [0.09, 2.08] |
| 1.19.8 Increased sputum production |
1 |
33 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.36 [0.09, 19.88] |
| 1.20 Adverse events 48 to 52 weeks |
3 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 1.20.1 All adverse events |
2 |
192 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.00 [0.92, 1.09] |
| 1.20.2 Serious adverse events |
2 |
192 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.85 [0.42, 1.69] |
| 1.20.3 Cough |
3 |
513 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.02 [0.87, 1.19] |
| 1.20.4 Chest tightness |
1 |
321 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.21 [0.01, 4.26] |
| 1.20.5 Vomiting |
1 |
321 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.52 [0.13, 2.03] |
| 1.20.6 Wheezing |
1 |
321 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.06 [0.38, 11.11] |
| 1.20.7 Fever |
3 |
513 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.73 [0.53, 1.00] |
| 1.20.8 Nasal congestion |
2 |
471 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.90 [0.63, 1.27] |
| 1.20.9 Ear infection |
2 |
363 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.27 [0.74, 2.17] |
| 1.20.10 Acquisition of Burkholderia cepacia
|
1 |
321 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.03 [0.15, 7.23] |
| 1.20.11 Abdominal distension / flatulence |
1 |
42 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.00 [0.71, 5.64] |
| 1.20.12 Rhinorrhoea |
1 |
42 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.70 [1.04, 2.79] |
| 1.20.13 Diarrhoea |
1 |
42 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.83 [0.30, 2.31] |
