Trial Outcomes & Findings for A Safety and Efficacy Study of Inhaled R940343 in Patients With Mild to Moderate Asthma (NCT NCT01591044)

NCT ID: NCT01591044

Last Updated: 2016-09-29

Results Overview

Change from baseline in pre-BD FEV1 (% predicted) at Week 8.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

301 participants

Primary outcome timeframe

Baseline and Week 8

Results posted on

2016-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	R940343 2mg, 2 Puffs Bid R343 2mg, 2 puffs bid R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid	Placebo Placebo: 1 puff bid or 2 puffs bid	R940343 1mg, 1 Puff Bid R343 1mg, 1 puff bid R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid
Overall Study STARTED	101	100	100
Overall Study COMPLETED	94	91	96
Overall Study NOT COMPLETED	7	9	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Safety and Efficacy Study of Inhaled R940343 in Patients With Mild to Moderate Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	R940343 2mg, 2 Puffs Bid n=101 Participants R343 2mg, 2 puffs bid R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid	Placebo n=100 Participants Placebo: 1, 1 puff bid or 2, 2 puffs bid	R940343 1mg, 1 Puff Bid n=100 Participants R343 1mg, 1 puff bid R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid	Total n=301 Participants Total of all reporting groups
Age, Continuous	39.5 years STANDARD_DEVIATION 13.5 • n=5 Participants	38.3 years STANDARD_DEVIATION 12.6 • n=7 Participants	39.3 years STANDARD_DEVIATION 12.8 • n=5 Participants	39.1 years STANDARD_DEVIATION 13 • n=4 Participants
Sex: Female, Male Female	51 Participants n=5 Participants	58 Participants n=7 Participants	55 Participants n=5 Participants	164 Participants n=4 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	42 Participants n=7 Participants	45 Participants n=5 Participants	137 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 8

Population: All efficacy endpoints were analyzed based on the intent to treat population consisting of all randomized patients.

Change from baseline in pre-BD FEV1 (% predicted) at Week 8.

Outcome measures

Outcome measures
Measure	R940343 2mg, 2 Puffs Bid n=101 Participants R343 2mg, 2 puffs bid R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid	Placebo n=100 Participants Placebo: 1, 1 puff bid or 2, 2 puffs bid	R940343 1mg, 1 Puff Bid n=100 Participants R343 1mg, 1 puff bid R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid
Change in FEV1	-0.40 percentage of change Standard Deviation 8.56	0.69 percentage of change Standard Deviation 9.31	-0.59 percentage of change Standard Deviation 8.75

Adverse Events

R940343 2mg, 2 Puffs Bid

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 48 other events

Deaths: 0 deaths

R940343 1mg, 1 Puff Bid

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Anne-Marie Duliege, MD

Rigel

Phone: 650-624-1100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	R940343 2mg, 2 Puffs Bid n=101 participants at risk R343 2mg, 2 puffs bid R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid	Placebo n=100 participants at risk Placebo: 1, 1 puff bid or 2, 2 puffs bid	R940343 1mg, 1 Puff Bid n=100 participants at risk R343 1mg, 1 puff bid R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid
Eye disorders Eye Disorders	0.99% 1/101 • Number of events 1 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	1.0% 1/100 • Number of events 1 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	1.0% 1/100 • Number of events 2 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).
Blood and lymphatic system disorders BLOOD AND LYMPHATIC SYSTEM DISORDERS	0.00% 0/101 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	1.0% 1/100 • Number of events 2 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	0.00% 0/100 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).
Cardiac disorders Cardiac Disorders	0.00% 0/101 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	2.0% 2/100 • Number of events 2 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	0.00% 0/100 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).
Ear and labyrinth disorders Ear and Labyrinth Disorders	0.99% 1/101 • Number of events 1 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	0.00% 0/100 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	0.00% 0/100 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).
Gastrointestinal disorders Gastrointestinal Disorders	0.99% 1/101 • Number of events 1 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	1.0% 1/100 • Number of events 1 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	2.0% 2/100 • Number of events 2 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).
General disorders General Disorders and Administration Site Conditions	0.00% 0/101 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	1.0% 1/100 • Number of events 1 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	0.00% 0/100 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).
Infections and infestations Infections and infestations	19.8% 20/101 • Number of events 20 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	26.0% 26/100 • Number of events 26 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	9.0% 9/100 • Number of events 9 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	2.0% 2/101 • Number of events 2 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	1.0% 1/100 • Number of events 1 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	2.0% 2/100 • Number of events 2 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).
Investigations Investigations	3.0% 3/101 • Number of events 3 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	3.0% 3/100 • Number of events 3 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	1.0% 1/100 • Number of events 1 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).
Musculoskeletal and connective tissue disorders Musculoskeletal and Connective Tissue Disorders	0.00% 0/101 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	3.0% 3/100 • Number of events 3 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	1.0% 1/100 • Number of events 1 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).
Nervous system disorders NERVOUS SYSTEM DISORDERS	0.99% 1/101 • Number of events 1 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	0.00% 0/100 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	1.0% 1/100 • Number of events 1 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).
Psychiatric disorders Psychiatric disorders	0.00% 0/101 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	0.00% 0/100 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	1.0% 1/100 • Number of events 1 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).
Renal and urinary disorders Renal and urinary disorders	0.00% 0/101 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	1.0% 1/100 • Number of events 1 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	0.00% 0/100 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).
Reproductive system and breast disorders Reproductive system and breast disorders	0.99% 1/101 • Number of events 1 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	1.0% 1/100 • Number of events 1 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	0.00% 0/100 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	4.0% 4/101 • Number of events 4 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	9.0% 9/100 • Number of events 9 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	8.0% 8/100 • Number of events 8 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).
Skin and subcutaneous tissue disorders Skin and Subcutaneous Tissue Disorders	2.0% 2/101 • Number of events 2 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	3.0% 3/100 • Number of events 3 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).	0.00% 0/100 • The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).