Trial Outcomes & Findings for Indacaterol EfectIveness In COPD Patients With Tuberculosis History (NCT NCT01778062)

NCT ID: NCT01778062

Last Updated: 2015-10-23

Results Overview

Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariate

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 136 participants
• Primary outcome timeframe: 8 week
• Results posted on: 2015-10-23

Participant Flow

Participant milestones

Measure	Indacaterol Indacaterol 150 µg once daily	Placebo Placebo once daily
Overall Study STARTED	68	68
Overall Study Safety Set	68	68
Overall Study Intent to Treat (ITT)	68	67
Overall Study COMPLETED	62	57
Overall Study NOT COMPLETED	6	11

Reasons for withdrawal

Measure	Indacaterol Indacaterol 150 µg once daily	Placebo Placebo once daily
Overall Study Adverse Event	1	3
Overall Study Consent Withdrawal	1	5
Overall Study major protocol deviation	4	3

Baseline Characteristics

Indacaterol EfectIveness In COPD Patients With Tuberculosis History

Baseline characteristics by cohort

Measure	Indacaterol n=68 Participants Indacaterol 150 µg once daily	Placebo n=68 Participants Placebo once daily	Total n=136 Participants Total of all reporting groups
Age, Continuous	63.96 Years STANDARD_DEVIATION 10.90 • n=5 Participants	64.62 Years STANDARD_DEVIATION 9.20 • n=7 Participants	64.29 Years STANDARD_DEVIATION 10.06 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	28 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	40 Participants n=7 Participants	85 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 week

Population: ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug.

Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariate

Outcome measures

Measure	Indacaterol n=68 Participants Indacaterol 150 µg once daily	Placebo n=67 Participants Placebo once daily
Trough Forced Expiratory Volume in One Second Change	0.08 Liters Standard Deviation 0.16	-0.06 Liters Standard Deviation 0.10

SECONDARY outcome

Timeframe: 8 week

Population: ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug.

The SGRQ-C contains 14 questions divided into two components. Part 1 produces "Symptoms" scores and Part 2 "Activity" and "Impacts" scores. 14 questions which are divided in three domains: "symptom" (question 1-7), "activity" (question 9, 12) and "impact" (question 8, 10, 11, 13 and 14). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Mixed model used baseline SGRQ, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.

Outcome measures

Measure	Indacaterol n=68 Participants Indacaterol 150 µg once daily	Placebo n=66 Participants Placebo once daily
St. George Respiratory Questionnaire for COPD (SGRQ-C) Change After 8 Weeks of Treatment	-2.69 Score on a scale Standard Deviation 13.00	-0.33 Score on a scale Standard Deviation 16.30

SECONDARY outcome

Timeframe: 8 week

Population: ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug.

TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to 1 hour post inhalation of ipratropium as covariates.

Outcome measures

Measure	Indacaterol n=68 Participants Indacaterol 150 µg once daily	Placebo n=66 Participants Placebo once daily
Change From Baseline in Transition Dyspnea Index (TDI) After 8 Weeks of Treatment	1.01 Score on a scale Standard Deviation 2.15	0.23 Score on a scale Standard Deviation 2.38

SECONDARY outcome

Timeframe: 8 week

Population: ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug

Number of COPD exacerbation during 8-week treatment. COPD exacerbations are defined as a new onset or worsening of at least one respiratory symptom (i.e. dyspnea, cough, sputum purulence or volume, or wheeze) present for at least 3 consecutive days, documented change or increase in COPD-related treatment due to worsening symptoms or documented COPD-related hospitalizations or emergency room visits.

Outcome measures

Measure	Indacaterol n=68 Participants Indacaterol 150 µg once daily	Placebo n=67 Participants Placebo once daily
Incidence of COPD Exacerbation	3 Participants	5 Participants

Adverse Events

Indacaterol

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Indacaterol n=68 participants at risk Indacaterol	Placebo n=68 participants at risk Placebo
Injury, poisoning and procedural complications Spinal fracture	1.5% 1/68	0.00% 0/68
Respiratory, thoracic and mediastinal disorders COPD Exacerbation	0.00% 0/68	1.5% 1/68
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.5% 1/68	0.00% 0/68
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.5% 1/68	0.00% 0/68

Other adverse events

Measure	Indacaterol n=68 participants at risk Indacaterol	Placebo n=68 participants at risk Placebo
Infections and infestations Nasopharyngitis	4.4% 3/68	5.9% 4/68
Infections and infestations Upper respiratory tract infection	4.4% 3/68	10.3% 7/68
Respiratory, thoracic and mediastinal disorders COPD Exacerbation	4.4% 3/68	7.4% 5/68

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