Trial Outcomes & Findings for Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations (NCT NCT02418468)

Last Updated: 2017-07-11

Results Overview

To compare the effects of indacaterol 150ug once dialy (od) to placebo in GOLD 2014 Group B COPD patients, in terms of 24-hour postdose (trough) forced expiratory volume in 1 second (FEV1) after 12 weeks of dosing.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

24 participants

Primary outcome timeframe

at week 12

Results posted on

2017-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	Indacaterol 150 mcg Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)	Placebo Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
Overall Study STARTED	13	11
Overall Study COMPLETED	11	10
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Indacaterol 150 mcg Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)	Placebo Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
Overall Study Adverse Event	1	0
Overall Study Withdrawal of informed consent	1	1

Baseline Characteristics

Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Indacaterol 150 mcg n=13 Participants Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)	Placebo n=11 Participants Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)	Total n=24 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 7.2 • n=5 Participants	68.8 years STANDARD_DEVIATION 14.96 • n=7 Participants	66 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: at week 12

Population: Full Analysis Set (FAS) - would include all randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients would be analyzed according to the treatment assigned at randomization.

Outcome measures

Outcome measures
Measure	Indacaterol 150 mcg n=13 Participants Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)	Placebo n=11 Participants Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks	1.76 Liters Standard Error 0.067	1.86 Liters Standard Error 0.061

Adverse Events

Indacaterol 150 mcg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Indacaterol 150 mcg n=11 participants at risk Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)	Placebo n=13 participants at risk Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
Infections and infestations Influenza viral infections	0.00% 0/11	7.7% 1/13
Injury, poisoning and procedural complications Thoracic cage fractures non-spinal	0.00% 0/11	7.7% 1/13
Skin and subcutaneous tissue disorders Epidermal and dermal conditions	9.1% 1/11	0.00% 0/13

Other adverse events

Other adverse events
Measure	Indacaterol 150 mcg n=11 participants at risk Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)	Placebo n=13 participants at risk Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
Ear and labyrinth disorders Inner ear signs and sympotoms	9.1% 1/11	0.00% 0/13
Eye disorders Corneal injuries	0.00% 0/11	7.7% 1/13
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/11	7.7% 1/13
Musculoskeletal and connective tissue disorders Joint related signs and symptoms	9.1% 1/11	0.00% 0/13
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders sign and symptoms NEC	0.00% 0/11	7.7% 1/13
Respiratory, thoracic and mediastinal disorders Bronchospasm and obstruction	0.00% 0/11	7.7% 1/13
Respiratory, thoracic and mediastinal disorders Coughing and associated symptoms	9.1% 1/11	0.00% 0/13
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Infection	0.00% 0/11	7.7% 1/13

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER