Table 1 Summary of RCTs in CF measuring QoL: antibiotics and steroids

ANTIBIOTICS

Quittner et al. [14]

Secondary analysis of Ramsey et al. [13]

Secondary analysis of RCT.

Tobramycin versus placebo in 3 cycles

n = 520 (age >= 6 years) (n = 499 for QoL)

mean age 21 years FEV₁ 25% to 75%

Non-validated 3-point scale (better/no change/worse) primary outcome

Tobramaycin improved lung function (not reported here)

Tobramycin associated with improved QoL

Equi et al. [17]

Azithromycin (250 gm or 500 gm dependent on weight) vs placebo; crossover design

n = 41 (age 8–18 years) median FEV₁ = 61% (range 33% to 80%)

QWB

Significant improvement in FEV₁ compared with placebo, but not FVC or mid-expiratory flow

No difference in QoL

Wolter et al. [18]

Azithromycin vs placebo; 2 parallel groups

n = 59 (age 18–44 years; mean 27.9 years) mean FEV₁ = 56.5%

CRQ

Significant difference in FEV₁ and FVC favouring azythromycin

Significant improvement in all domains of QoL

Saiman et al. [19]

Azithromicyn vs placebo; 2 parallel groups

n = 185 (age >= 6 years) (n= 177 for QoL)

mean age 20 years ≈ 60% had FEV₁ > 60%

CFQ

Significant difference in FEV₁, lower risk of exacerbation, higher weight, but more side effects in treatment group

Significant difference in physical functioning domain only

HOME/HOSPITAL ANTIBIOTICS

Wolter et al. [20]

Home versus hospital IVs antibiotics; 2 parallel groups

17 adolescents and adults

CRQ primary outcome

No clinical compromise associated with home therapy

Home IVs fared worse for fatigue and mastery, but better for personal, family, sleeping, eating and total disruption

STEROIDS

Balfour-Lynn et al. [24]

Corticosteroids vs placebo; crossover

n = 22 (age 7–17 years; mean 10.3 years)

mean FEV₁= 64% (range 21% to 102%)

Ad hoc VAS scales

No significant benefit in any of the outcomes

No changes in well-being