Trial Outcomes & Findings for Efficacy and Safety of Indacaterol in Adults (40 Years and Above) With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00792805)

Last Updated: 2011-08-17

Results Overview

FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

563 participants

Primary outcome timeframe

Week 12 + 1 day, Day 85

Results posted on

2011-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	Indacaterol 150 μg Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Indacaterol 300 μg Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Placebo to Indacaterol Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Overall Study STARTED	188	188	187
Overall Study Exposed to Study Medication or Placebo	187	188	186
Overall Study COMPLETED	166	162	154
Overall Study NOT COMPLETED	22	26	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Indacaterol 150 μg Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Indacaterol 300 μg Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Placebo to Indacaterol Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Overall Study Adverse Event	12	10	10
Overall Study Subject withdrew consent	5	6	5
Overall Study Administrative problems	2	0	4
Overall Study Abnormal test procedure result(s)	1	2	0
Overall Study Unsatisfactory therapeutic effect	1	6	6
Overall Study Lost to Follow-up	1	1	6
Overall Study Abnormal laboratory value(s)	0	0	1
Overall Study Protocol deviation	0	1	1

Baseline Characteristics

Efficacy and Safety of Indacaterol in Adults (40 Years and Above) With Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=561 Participants Total of all reporting groups	Indacaterol 150 μg n=187 Participants Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Indacaterol 300 μg n=188 Participants Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Placebo to Indacaterol n=186 Participants Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Age Continuous	65.4 years STANDARD_DEVIATION 8.75 • n=483 Participants	66.2 years STANDARD_DEVIATION 8.01 • n=93 Participants	65.5 years STANDARD_DEVIATION 8.86 • n=4 Participants	64.6 years STANDARD_DEVIATION 9.30 • n=27 Participants
Sex: Female, Male Female	32 Participants n=483 Participants	12 Participants n=93 Participants	7 Participants n=4 Participants	13 Participants n=27 Participants
Sex: Female, Male Male	529 Participants n=483 Participants	175 Participants n=93 Participants	181 Participants n=4 Participants	173 Participants n=27 Participants

PRIMARY outcome

Timeframe: Week 12 + 1 day, Day 85

Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized to impute missing data.

Outcome measures

Outcome measures
Measure	Indacaterol 150 μg n=176 Participants Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Indacaterol 300 μg n=178 Participants Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Placebo to Indacaterol n=171 Participants Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85	1.32 Liters Standard Error 0.024	1.29 Liters Standard Error 0.024	1.17 Liters Standard Error 0.024

Adverse Events

Indacaterol 150 μg

Serious events: 12 serious events

Other events: 38 other events

Deaths: 0 deaths

Indacaterol 300 μg

Serious events: 12 serious events

Other events: 50 other events

Deaths: 0 deaths

Placebo to Indacaterol

Serious events: 15 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Indacaterol 150 μg n=187 participants at risk Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Indacaterol 300 μg n=188 participants at risk Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Placebo to Indacaterol n=186 participants at risk Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Infections and infestations Nasopharyngitis	8.6% 16/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	7.4% 14/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	3.2% 6/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	4.8% 9/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	6.9% 13/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	8.6% 16/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	15.5% 29/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	18.6% 35/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	19.4% 36/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.

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 (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Indacaterol 150 μg n=187 participants at risk Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Indacaterol 300 μg n=188 participants at risk Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Placebo to Indacaterol n=186 participants at risk Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Cardiac disorders Angina unstable	0.00% 0/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.54% 1/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Cardiac disorders Ventricular extrasystoles	0.00% 0/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.54% 1/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Eye disorders Eye oedema	0.53% 1/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.53% 1/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Gastrointestinal disorders Intestinal polyp	0.53% 1/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
General disorders Oedema peripheral	0.53% 1/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Immune system disorders Drug hypersensitivity	0.00% 0/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.54% 1/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Infections and infestations Cellulitis	0.00% 0/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.54% 1/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Infections and infestations Lung abscess	0.00% 0/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.53% 1/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Infections and infestations Pneumonia	0.53% 1/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.54% 1/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection bacterial	0.00% 0/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	1.1% 2/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	1.1% 2/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.54% 1/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Femoral neck fracture	0.53% 1/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.53% 1/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.54% 1/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.00% 0/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.54% 1/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.53% 1/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Nervous system disorders Hypoaesthesia	0.53% 1/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Nervous system disorders Lacunar infarction	0.53% 1/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.2% 6/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	4.8% 9/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	3.8% 7/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.53% 1/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.
Vascular disorders Hypertension	0.00% 0/187 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.00% 0/188 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.	0.54% 1/186 • Baseline to the end of the study (Week 26) Safety population: All patients who received at least 1 dose of study drug.