Trial Outcomes & Findings for A Study to Investigate the Bronchodilatory Effect of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00856193)

Results Overview

Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from predose (day 1) to the readings taken 0-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

From Day 1 to 0-24 hours after drug administration on Day 14

Results posted on

2016-09-14

Participant Flow

Patients were randomized into one of two sequences to receive either NVA237 50 μg followed by placebo or placebo followed by NVA237 50 μg.

Participant milestones

Participant milestones
Measure	NVA237 50μg Then Placebo NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device.	Placebo Then NVA237 50μg Placebo 50 µg capsules followed by NVA237 50 µg capsules for inhalation once daily with Concept 1 device.
Period 1 STARTED	16	17
Period 1 COMPLETED	16	17
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	16	17
Period 2 COMPLETED	16	15
Period 2 NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	NVA237 50μg Then Placebo NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device.	Placebo Then NVA237 50μg Placebo 50 µg capsules followed by NVA237 50 µg capsules for inhalation once daily with Concept 1 device.
Period 2 Abnormal test procedure results	0	1
Period 2 Lost to Follow-up	0	1

Baseline Characteristics

A Study to Investigate the Bronchodilatory Effect of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Randomized Patients n=33 Participants NVA237 50 μg capsules for inhalation once daily with Concept 1 device. Matching placebo 50 µg capsules for inhalation once daily with Concept 1 device.
Age, Continuous	60.5 years STANDARD_DEVIATION 9.13 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Day 1 to 0-24 hours after drug administration on Day 14

Population: Efficacy analysis set

Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from predose (day 1) to the readings taken 0-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.

Outcome measures

Outcome measures
Measure	NVA237 50μg n=31 Participants NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.	Placebo n=32 Participants Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14	1.827 Liters Standard Error 0.0330	1.664 Liters Standard Error 0.0324

SECONDARY outcome

Timeframe: From day 1 to 0 -12 hours after drug administration on Day 14

Population: Efficacy analysis set

Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 0-12 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.

Outcome measures

Outcome measures
Measure	NVA237 50μg n=31 Participants NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.	Placebo n=32 Participants Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours on Day 14	1.879 Liters Standard Error 0.0346	1.714 Liters Standard Error 0.0340

SECONDARY outcome

Timeframe: From Day 1 to 12 hours-24 hours after drug administration on Day 14

Population: Efficacy analysis set

Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 12-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.

Outcome measures

Outcome measures
Measure	NVA237 50μg n=31 Participants NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.	Placebo n=32 Participants Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours on Day 14	1.776 Liters Standard Error 0.0344	1.615 Liters Standard Error 0.0339

SECONDARY outcome

Timeframe: Day 14

Population: Safety Population

According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening , causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. See Adverse Events module for details.

Outcome measures

Outcome measures
Measure	NVA237 50μg n=31 Participants NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.	Placebo n=33 Participants Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) Overall Adverse Events	2 Participants	4 Participants
Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) Serious Adverse Events (SAEs)	0 Participants	0 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

NVA237 50 μg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=33 participants at risk Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.	NVA237 50 μg n=31 participants at risk NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
Gastrointestinal disorders Gastrointestinal disorders	6.1% 2/33 • Number of events 2	0.00% 0/31

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.
Publication restrictions are in place

Restriction type: OTHER