Trial Outcomes & Findings for Inhaled Ciclesonide for Outpatients With COVID19 (NCT NCT04435795)

NCT ID: NCT04435795

Last Updated: 2022-06-10

Results Overview

Proportion of participants with no symptoms of cough, fever or dyspnea at day 7

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 215 participants
• Primary outcome timeframe: day 7
• Results posted on: 2022-06-10

Participant Flow

Enrolment to the trial began on 15 September 2020 in Quebec, 9 February 2021 in Ontario, and 22 March 2021 in British Columbia. The last participants were recruited on 8 June 2021.

Overall, 215 participants were randomised, and the modified intention-to-treat population included 203 adults with respiratory symptoms or fever.

Participant milestones

Measure	Ciclesonide Inhaled and Nasal Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE	Placebo Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
Overall Study STARTED	108	107
Overall Study COMPLETED	105	98
Overall Study NOT COMPLETED	3	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Inhaled Ciclesonide for Outpatients With COVID19

Baseline characteristics by cohort

Measure	Ciclesonide Inhaled and Nasal n=105 Participants Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE	Placebo n=98 Participants Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID	Total n=203 Participants Total of all reporting groups
Age, Continuous	35 years n=5 Participants	35 years n=7 Participants	35 years n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	55 Participants n=7 Participants	109 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	43 Participants n=7 Participants	94 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · African canadian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Asian	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · White	63 Participants n=5 Participants	53 Participants n=7 Participants	116 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Middle Eastern	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · South Asian	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Other	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Canada · British Columbia	51 Participants n=5 Participants	51 Participants n=7 Participants	102 Participants n=5 Participants
Region of Enrollment Canada · Ontario	19 Participants n=5 Participants	13 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment Canada · Quebec	35 Participants n=5 Participants	34 Participants n=7 Participants	69 Participants n=5 Participants

PRIMARY outcome

Timeframe: day 7

Proportion of participants with no symptoms of cough, fever or dyspnea at day 7

Outcome measures

Measure	Ciclesonide Inhaled and Nasal n=105 Participants Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE	Placebo n=98 Participants Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea	42 Participants	34 Participants

SECONDARY outcome

Timeframe: Day 14

Proportion of participants with no symptoms of cough, fever or dyspnea at Day 14

Outcome measures

Measure	Ciclesonide Inhaled and Nasal n=105 Participants Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE	Placebo n=98 Participants Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea	95 Participants	91 Participants

SECONDARY outcome

Timeframe: Day 7

Proportion who are reporting that they are "very much improved" or "much improved"

Outcome measures

Measure	Ciclesonide Inhaled and Nasal n=105 Participants Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE	Placebo n=98 Participants Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 7	77 Participants	74 Participants

SECONDARY outcome

Timeframe: Day 14

Proportion who are reporting that they are "very much improved" or "much improved"

Outcome measures

Measure	Ciclesonide Inhaled and Nasal n=105 Participants Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE	Placebo n=98 Participants Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 14	95 Participants	91 Participants

SECONDARY outcome

Timeframe: day 7

Dyspnea was defined as reporting "shortness of breath" or "chest congestion" or "chest tightness". In those who reported dyspnea at baseline, resolution will be defined as having no symptoms in these three areas.

Outcome measures

Measure	Ciclesonide Inhaled and Nasal n=53 Participants Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE	Placebo n=49 Participants Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
Improvement in Dyspnea: Resolution of Dyspnea at Day 7	38 Participants	27 Participants

SECONDARY outcome

Timeframe: day 7

Improvement of wet or dry cough. Analysis limited to patients who reported cough at baseline. Defined as a 2 point decrease, or a decrease to 0 on a visual analogue scale that ranged from 0 for no symptoms to 10 for severe symptoms

Outcome measures

Measure	Ciclesonide Inhaled and Nasal n=89 Participants Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE	Placebo n=86 Participants Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
Improvement in Cough at Day 7: Proportion of Patient With a Reduction of Cough Symptoms at Day 7	57 Participants	54 Participants

SECONDARY outcome

Timeframe: day 14

Hospitalization for SARS-CoV-2 related illness

Outcome measures

Measure	Ciclesonide Inhaled and Nasal n=105 Participants Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE	Placebo n=98 Participants Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
Proportion of Participants Hospitalized for SARS-CoV-2	6 Participants	3 Participants

SECONDARY outcome

Timeframe: day 29

All cause mortality

Outcome measures

Measure	Ciclesonide Inhaled and Nasal n=105 Participants Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE	Placebo n=98 Participants Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
Mortality	0 Participants	0 Participants

Adverse Events

Ciclesonide Inhaled and Nasal

Serious events: 7 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ciclesonide Inhaled and Nasal n=105 participants at risk Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE	Placebo n=98 participants at risk Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
Respiratory, thoracic and mediastinal disorders Hospithalization	5.7% 6/105 • 29 Days	3.1% 3/98 • 29 Days
Respiratory, thoracic and mediastinal disorders Visit to the emergency department	0.95% 1/105 • 29 Days	3.1% 3/98 • 29 Days

Other adverse events

Measure	Ciclesonide Inhaled and Nasal n=105 participants at risk Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE	Placebo n=98 participants at risk Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
Respiratory, thoracic and mediastinal disorders Thrush	1.9% 2/105 • 29 Days	0.00% 0/98 • 29 Days
General disorders Severe headache	12.4% 13/105 • 29 Days	5.1% 5/98 • 29 Days
General disorders Voice change	1.9% 2/105 • 29 Days	2.0% 2/98 • 29 Days
General disorders throat irritaiton	6.7% 7/105 • 29 Days	5.1% 5/98 • 29 Days
General disorders Dry mouth	1.9% 2/105 • 29 Days	3.1% 3/98 • 29 Days
General disorders Dry nose, irritated nose or nosebleed	3.8% 4/105 • 29 Days	1.0% 1/98 • 29 Days
General disorders Dizziness	0.95% 1/105 • 29 Days	0.00% 0/98 • 29 Days
General disorders Nausea	10.5% 11/105 • 29 Days	2.0% 2/98 • 29 Days
General disorders Wheeze	0.00% 0/105 • 29 Days	1.0% 1/98 • 29 Days
General disorders Other	5.7% 6/105 • 29 Days	3.1% 3/98 • 29 Days

Additional Information

Dr Nicole EZER

Research Institute of the McGill University Health Center

Phone: 514-934-1934

Email: nicole.ezer@mcgill.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place