Trial Outcomes & Findings for Indacaterol 75 μg Compared to Placebo, Assessing Time to Patient's Perception of Onset of Effect in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (NCT NCT01543828)

NCT ID: NCT01543828

Last Updated: 2013-05-10

Results Overview

Defined as the first time point that the patient responds "yes" to the following self-administered question: "I feel that the drug is working in improving my breathing?"

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: 5, 7.5, 10, 15, 20, 30, 40, 50, and 60 minutes post dose for treatment 1 and treatment 2
• Results posted on: 2013-05-10

Participant Flow

Participant milestones

Measure	Indacaterol Then Placebo In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.	Placebo Then Indacaterol In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
Treatment 1 STARTED	20	20
Treatment 1 COMPLETED	20	20
Treatment 1 NOT COMPLETED	0	0
Treatment 2 STARTED	20	19
Treatment 2 COMPLETED	19	19
Treatment 2 NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Indacaterol Then Placebo In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.	Placebo Then Indacaterol In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
Treatment 2 Lost to Follow-up	1	0

Baseline Characteristics

Indacaterol 75 μg Compared to Placebo, Assessing Time to Patient's Perception of Onset of Effect in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Baseline characteristics by cohort

Measure	Indacaterol Then Placebo n=20 Participants In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.	Placebo Then Indacaterol n=20 Participants In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.	Total n=40 Participants Total of all reporting groups
Age Continuous	62.2 years STANDARD_DEVIATION 10.29 • n=93 Participants	60.8 years STANDARD_DEVIATION 6.90 • n=4 Participants	61.5 years STANDARD_DEVIATION 8.68 • n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	4 Participants n=4 Participants	13 Participants n=27 Participants
Sex: Female, Male Male	11 Participants n=93 Participants	16 Participants n=4 Participants	27 Participants n=27 Participants

PRIMARY outcome

Timeframe: 5, 7.5, 10, 15, 20, 30, 40, 50, and 60 minutes post dose for treatment 1 and treatment 2

Population: Full Analysis Set included all participants who received one dose of study drug.

Defined as the first time point that the patient responds "yes" to the following self-administered question:

"I feel that the drug is working in improving my breathing?"

Outcome measures

Measure	indacaterol_treatment 1 n=20 Participants In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI). Albuterol was available for use as rescue medication.	indacaterol_treatment 2 n=19 Participants In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.	placebo_treatment 1 n=20 Participants In treatment 1, participants received placebo one dose delivered via SDDPI. Albuterol was available for use as rescue medication.	placebo_treatment 2 n=20 Participants In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
Time (in Minutes) to Patient's Perception of Onset of Effect	25.13 Minutes Standard Deviation 27.726	26.05 Minutes Standard Deviation 28.787	21.88 Minutes Standard Deviation 25.928	25.88 Minutes Standard Deviation 27.449

Adverse Events

Indacaterol

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Indacaterol n=40 participants at risk Participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI).	Placebo n=40 participants at risk Participants received placebo one dose delivered via SDDPI.
Respiratory, thoracic and mediastinal disorders Cough	5.0% 2/40	0.00% 0/40

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