Table 1 Description of indacaterol studies using a tiotropium comparator arm*

INHANCE [9]

Randomised, double-blind, placebo-controlled study assessing efficacy, safety and tolerability of two doses of indacaterol in patients with COPD using open-label tiotropium as active control

Double-blind indacaterol and placebo via Breezhaler^®. Open-label tiotropium via HandiHaler^®

No placebo to tiotropium was available.* Tiotropium was administered open-label

FEV₁ <80 and ≥30% predicted FEV₁/FVC <70%. Smoking history ≥20 pack-years

26 weeks

First objective: superiority of indacaterol to placebo using trough FEV₁ at 12 weeks. Second objective: non-inferiority of indacaterol to tiotropium using trough FEV₁ at 12 weeks

INTIME [10]

Randomised, blinded, placebo-controlled, multicentre, three-period, incomplete block, multi-dose crossover study to determine the effect on lung function of indacaterol in patients with moderate-to-severe COPD, using tiotropium as an active control

Double-blind indacaterol and placebo via Breezhaler^®. Third-party blinding of tiotropium (via HandiHaler^®)^†

Indacaterol and its matching placebo were made identical in appearance and were dispensed in such a manner to make them indistinguishable to patients and all blinded study personnel. An exact physical match to tiotropium was not available. Blinding of tiotropium was maintained by use of third-party blinding procedures^†

FEV₁ <80 and ≥30% predicted FEV₁/FVC <70%. Smoking history ≥10 pack-years

70 days (14 days treatment with four different treatments in three separate periods with a washout of 14 days between treatments)

First objective: superiority of indacaterol to placebo using trough FEV₁ at 14 days. Second objective: non-inferiority of indacaterol to tiotropium using trough FEV₁ at 14 days

INTENSITY [11]

Randomised, parallel-group, blinded, double-dummy study to compare the efficacy and safety of indacaterol delivered via a SDDPI with tiotropium delivered via a HandiHaler^® in patients with moderate-to-severe COPD

Blind, double-dummy indacaterol via Breezhaler^® versus tiotropium via HandiHaler^®

Patients receiving indacaterol also took placebo via the inhaler used for tiotropium, and patients receiving tiotropium took placebo via the inhaler used for indacaterol. The colour of the capsules was compatible, but the placebo did not have the markings. The blinding of tiotropium was maintained by use of an unblinded individual, who was not involved in any study assessments, to administer treatment. Patients and investigators therefore remained blind to treatment allocation

FEV₁ <80 and ≥30% predicted FEV₁/FVC <70%. Smoking history ≥10 pack-years

12 weeks

First objective: non-inferiority of indacaterol to tiotropium using trough FEV₁ at 12 weeks Second objective: superiority of indacaterol to tiotropium using trough FEV₁ at 12 weeks