Trial Outcomes & Findings for Inspiratory Flow Rates Achieved by the COPD Patients Through Breezhaler®, Ellipta® and Handihaler® Inhaler Devices (NCT NCT02596009)

Results Overview

The peak inspiratory flows (PIF) rates obtained from the inhalation flow profiles generated by the COPD patients through the three dry powder inhalation (DPI) devices(Breezhaler®, Ellipta® and Handihaler®) were measured and compared (without drug or placebo administration). Each patient were required to generate inhalation flow profiles through all three DPI devices in a randomized cross-over sequence. The inspiratory measurements were taken in each of these devices in the same visit.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

97 participants

Primary outcome timeframe

Visit 2 (Day 1)

Results posted on

2018-06-26

Participant Flow

Out of the 97 screened and randomized patients, 96 patients (99.0%) completed the study.

No active drug or placebo was administered in this study. The patients were to continue on their respective current maintenance COPD treatment as deemed appropriate by the treating physician. Each patient was required to inhale through all three study devices at the same visit in a randomized cross-over sequence.

Participant milestones

Participant milestones
Measure	Breezhaler/Ellipta/Handihaler Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).	Breezhaler/Handihaler/Ellipta Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).	Ellipta/Breezhaler/Handihaler Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).	Ellipta/Handihaler/Breezhaler Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).	Handihaler/Breezhaler/Ellipta Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).	Handihaler/Ellipta/Breezhaler Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).
Overall Study STARTED	14	16	16	16	18	17
Overall Study COMPLETED	14	15	16	16	18	17
Overall Study NOT COMPLETED	0	1	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Breezhaler/Ellipta/Handihaler Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).	Breezhaler/Handihaler/Ellipta Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).	Ellipta/Breezhaler/Handihaler Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).	Ellipta/Handihaler/Breezhaler Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).	Handihaler/Breezhaler/Ellipta Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).	Handihaler/Ellipta/Breezhaler Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).
Overall Study Administrative problems	0	1	0	0	0	0

Baseline Characteristics

Inspiratory Flow Rates Achieved by the COPD Patients Through Breezhaler®, Ellipta® and Handihaler® Inhaler Devices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Breezhaler/Ellipta/Handihaler n=97 Participants Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).
Age, Customized 40 - 64 years	27 Years n=5 Participants
Age, Customized 65 - 74 years	46 Years n=5 Participants
Age, Customized ≥75 years	24 Years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 2 (Day 1)

Population: Per-protocol set (PPS): This PPS population consisted of all randomized patients, who completed inhalation flow maneuvers through all three inhaler devices.

The peak inspiratory flows (PIF) rates obtained from the inhalation flow profiles generated by the COPD patients through the three dry powder inhalation (DPI) devices(Breezhaler®, Ellipta® and Handihaler®) were measured and compared (without drug or placebo administration). Each patient were required to generate inhalation flow profiles through all three DPI devices in a randomized cross-over sequence. The inspiratory measurements were taken in each of these devices in the same visit.

Outcome measures

Outcome measures
Measure	Breezhaler® n=93 Participants Each patient was required to inhale via Breezhaler® in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).	Ellipta® n=88 Participants Each patient were required to inhale via Ellipta® in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).	Handihaler® n=93 Participants Each patient were required to inhale via Handihaler® in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).
Peak Inspiratory Flows Rates Summary by Inhalation Devices - PPS	107.52 L/min Standard Deviation 23.335	80.73 L/min Standard Deviation 18.440	53.59 L/min Standard Deviation 20.629

PRIMARY outcome

Timeframe: Visit 2 (Day 1)

Population: Full Analysis Set (FAS): The FAS set consisted of all randomized patients who carried out inhalation maneuver through at least one inhaler.

The peak inspiratory flows (PIF) rates obtained from the inhalation flow profiles generated by the COPD patients through the three dry powder inhalation (DPI) devices(Breezhaler®, Ellipta® and Handihaler®) were measured and compared (without drug or placebo administration). Each patient were required to generate inhalation flow profiles through all three DPI devices in a randomized cross-over sequence. The inspiratory measurements were taken in each of these devices in the same visit. This FAS dataset includes PIF data from additional patients with corrected inhaler internal resistance values.

Outcome measures

Outcome measures
Measure	Breezhaler® n=97 Participants Each patient was required to inhale via Breezhaler® in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).	Ellipta® n=91 Participants Each patient were required to inhale via Ellipta® in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).	Handihaler® n=97 Participants Each patient were required to inhale via Handihaler® in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).
Peak Inspiratory Flows Rates Summary by Inhalation Devices - FAS	108 L/min Standard Deviation 23	78 L/min Standard Deviation 15	49 L/min Standard Deviation 9

Adverse Events

Breezhaler/Ellipta/Handihaler

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

Principal investigator is a sponsor employee Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. 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