IMPALA-X

14 evidence topics · 3 sources

Objective

Long-term safety objective

“To investigate safety of long term use of inhaled molgramostim.” (opens the source at this quote in a new tab)

Location and study date

Participating centers and originally planned study period

Attribute	Quoted specification
Participating centers	“Centres participating in the IMPALA (MOL-PAP-002) trial”
Estimated first enrollment	“Q1 2018”
Estimated last completion	“Q4 2021”

Study design

Uncontrolled extension study

Design component	Quoted specification
Design	“open-label, non-controlled”
Planned treatment duration	“up to 36-month treatment period”

Eligibility criteria

Entry after the preceding IMPALA study

“Completed the IMPALA study” (opens the source at this quote in a new tab)

Treatment

Intermittent inhaled molgramostim

Treatment component	Quoted specification
Daily dose during treatment weeks	“300 μg/day”
Intermittent schedule	“1 week on and 1 week off”

Study outcomes

Rationale for using adverse events as the primary endpoint

Not applicable.

Statistical analysis description

Number of participants (Planned and analyzed)

Planned enrollment

Planning measure	Participants
Maximum planned enrollment	“90”

Enrolled participants

“n = 60” (opens the source at this quote in a new tab)

Description of analysis sets

Descriptive safety analysis

“Descriptive statistics were used to summarize AEs” (opens the source at this quote in a new tab)

Analysis populations and exposure

Measure	Reported value
Full analysis set	“60”
Safety analysis set	“59”
Molgramostim exposure, patient-years	“93.4”

Results

Participant disposition

Early discontinuation of the extension

“discontinued early as intermittent dosing did not show substantial evidence of benefit vs placebo (PBO) in the IMPALA trial” (opens the source at this quote in a new tab)

Completion of the planned treatment duration

Disposition measure	Reported value
Participants completing the planned 36 months	“no patients”

Baseline characteristics

Characteristics by preceding randomized treatment

Characteristic	Prior continuous molgramostim, 15 participants	Prior intermittent molgramostim, 23 participants	Prior placebo, 22 participants
Age, years, mean and standard deviation	“48.7 (14.0)”	“46.7 (12.8)”	“45.6 (14.4)”
Male, number and percentage	“7 (46.7)”	“18 (78.3)”	“11 (50.0)”

Efficacy results

No evidence found.

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

Serious treatment-emergent events and mortality

Safety finding	Quoted value
Participants experiencing serious treatment-emergent adverse events	“Eight”
Attribution of those serious events to study treatment	“none”
Reported deaths due to COVID-19 infection	“One”
Interval between final molgramostim dose and the reported death	“24 days”

Study limitations

Summary

IMPALA-X was an uncontrolled extension that enrolled 60 participants, with 59 included in the safety analysis. It was terminated early, and no participant completed the planned 36 months. The reported exposure was 93.4 patient-years. Selection from participants who completed the preceding study and the absence of a concurrent comparator limit interpretation of adverse-event frequencies. The intermittent regimen was not pursued after the preceding IMPALA results and should not be treated as equivalent to the continuous daily regimen studied in IMPALA-2.