Trial Outcomes & Findings for Efficacy and Safety of Inhaled CMS in Bronchiectasis Subjects With Chronic P. Aeruginosa Infection. (PROMIS-I) (NCT NCT03093974)

Last Updated: 2023-11-15

Results Overview

The primary efficacy assessment for an individual subject was the frequency of pulmonary exacerbations (exacerbation rate). A pulmonary exacerbation was defined as the presence concurrently of at least three of the following eight symptoms/signs for at least 24 hours: * increased cough; * increased sputum volume and/or consistency; * increased sputum purulence; * new or increased haemoptysis; * increased wheezing; * increased dyspnoea; * increased fatigue/malaise; * episodes of fever (temperature ≥38°C). AND It was clinically determined that the subject required and was prescribed systemic antibiotic therapy. AND The episode of exacerbation lasted for at least 24 hours. The overall episode of exacerbation needs to last at least 24 hours, but individual symptoms/signs can last less than 24 hours (e.g, a temperature). AND in the opinion of the Investigator, the subject required and started treatment with systemic antibiotics.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

377 participants

Primary outcome timeframe

12 months

Results posted on

2023-11-15

Participant Flow

Recruitment was halted with 377 subjects randomised.

Participant milestones

Participant milestones
Measure	CMS (Colistimethate Sodium) Inhaled colistimethate sodium twice daily. The active pharmaceutical ingredient consisting of pure CMS one million international units (MIU) / 80 mg of CMS / 33 mg colistin base activity (CBA) was provided as a powder for nebuliser solution in 10R International Organization for Standardization (ISO) glass vials CMS: 1 M units equivalent to 80 mg colistimethate sodium diluted in 1 mL saline solution 0.45%. Investigational Medicinal Product (IMP) glass vials were shrink wrapped in opaque white plastic and provided in boxes of 30 vials (two weeks of b.i.d dosing). The 1 MIU/mL CMS/0.45% saline solution was transferred from the glass vial into a nebuliser system fitted with a 0.3 mL medication chamber, for administration by inhalation. This delivered a nominal dose of 0.3 MIU/24 mg CMS (\~10 mg CBA) from the device. The first dose of the IMP was administered at the site under the supervision of the site staff and pts were instructed how to prepare and self-administer the IMP at home via the nebulizer system, b.i.d (morning and evening) over a period of 12 months. At least 10 minutes (min) before each administration, an inhaled short-acting bronchodilator (e.g., salbutamol /albuterol), supplied by the Sponsor, could be taken to improve tolerability.	Placebo Saline solution inhaled twice daily, provided and adminitered at the same way of the IMP. Placebo: 1 ml saline solution 0.45%. the placebo was made up of identical empty glass vials to which the same saline diluent was added in exactly the same way as the reconstitution of the active treatment by injecting the diluent through the rubber stopper. The glass vials were shrink wrapped with opaque white plastic to maintain the blind.
Overall Study STARTED	177	200
Overall Study Modified Intention to Treat Population - (mITT)	176	197
Overall Study Safety Population (SAF)	176	197
Overall Study Per -Protocol Population (PP)	117	122
Overall Study COMPLETED	123	129
Overall Study NOT COMPLETED	54	71

Reasons for withdrawal

Reasons for withdrawal
Measure	CMS (Colistimethate Sodium) Inhaled colistimethate sodium twice daily. The active pharmaceutical ingredient consisting of pure CMS one million international units (MIU) / 80 mg of CMS / 33 mg colistin base activity (CBA) was provided as a powder for nebuliser solution in 10R International Organization for Standardization (ISO) glass vials CMS: 1 M units equivalent to 80 mg colistimethate sodium diluted in 1 mL saline solution 0.45%. Investigational Medicinal Product (IMP) glass vials were shrink wrapped in opaque white plastic and provided in boxes of 30 vials (two weeks of b.i.d dosing). The 1 MIU/mL CMS/0.45% saline solution was transferred from the glass vial into a nebuliser system fitted with a 0.3 mL medication chamber, for administration by inhalation. This delivered a nominal dose of 0.3 MIU/24 mg CMS (\~10 mg CBA) from the device. The first dose of the IMP was administered at the site under the supervision of the site staff and pts were instructed how to prepare and self-administer the IMP at home via the nebulizer system, b.i.d (morning and evening) over a period of 12 months. At least 10 minutes (min) before each administration, an inhaled short-acting bronchodilator (e.g., salbutamol /albuterol), supplied by the Sponsor, could be taken to improve tolerability.	Placebo Saline solution inhaled twice daily, provided and adminitered at the same way of the IMP. Placebo: 1 ml saline solution 0.45%. the placebo was made up of identical empty glass vials to which the same saline diluent was added in exactly the same way as the reconstitution of the active treatment by injecting the diluent through the rubber stopper. The glass vials were shrink wrapped with opaque white plastic to maintain the blind.
Overall Study Withdrawal by Subject	32	27
Overall Study Adverse Event	17	24
Overall Study Death	0	1
Overall Study Non-Compliance with Study Drug	1	0
Overall Study Protocol-Specified withdrawal criterion met	3	16
Overall Study Lost to Follow-up	0	1
Overall Study Other	1	2

Baseline Characteristics

Age continuous data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CMS (Colistimethate Sodium) n=177 Participants Inhaled colistimethate sodium twice daily. The active pharmaceutical ingredient consisting of pure CMS one million international units (MIU) / 80 mg of CMS / 33 mg colistin base activity (CBA) was provided as a powder for nebuliser solution in 10R International Organization for Standardization (ISO) glass vials CMS: 1 MIU equivalent to 80 mg colistimethate sodium diluted in 1 mL saline solution 0.45%. Investigational Medicinal Product (IMP) glass vials were shrink wrapped in opaque white plastic and provided in boxes of 30 vials (two weeks of b.i.d dosing). The 1 MIU/mL CMS/0.45% saline solution was transferred from the glass vial into a specific nebuliser system fitted with a 0.3 mL medication chamber, for administration by inhalation. This delivered a nominal dose of 0.3 MIU/24 mg CMS (\~10 mg CBA) from the device. The first dose of the IMP was administered at the site under the supervision of the site staff and subjects were instructed how to prepare and self-administer the IMP at home via a specific nebuliser system, b.i.d (morning and evening) over a period of 12 months. At least 10 minutes (min) before each administration, an inhaled short-acting bronchodilator (e.g., salbutamol /albuterol), supplied by the Sponsor, could be taken to improve tolerability.	Placebo n=200 Participants Saline solution inhaled twice daily, provided and adminitered at the same way of the IMP. Placebo: 1 ml saline solution 0.45%. the placebo was made up of identical empty glass vials to which the same saline diluent was added in exactly the same way as the reconstitution of the active treatment by injecting the diluent through the rubber stopper. The glass vials were shrink wrapped with opaque white plastic to maintain the blind.	Total n=377 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=177 Participants	0 Participants n=200 Participants	1 Participants n=377 Participants
Age, Categorical Between 18 and 65 years	69 Participants n=177 Participants	88 Participants n=200 Participants	157 Participants n=377 Participants
Age, Categorical >=65 years	107 Participants n=177 Participants	112 Participants n=200 Participants	219 Participants n=377 Participants
Age, Continuous	64.2 years STANDARD_DEVIATION 14.86 • n=176 Participants • Age continuous data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	64.2 years STANDARD_DEVIATION 13.06 • n=197 Participants • Age continuous data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	64.2 years STANDARD_DEVIATION 13.92 • n=373 Participants • Age continuous data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)
Sex: Female, Male Female	123 Participants n=176 Participants • Sex data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	126 Participants n=197 Participants • Sex data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	249 Participants n=373 Participants • Sex data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)
Sex: Female, Male Male	53 Participants n=176 Participants • Sex data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	71 Participants n=197 Participants • Sex data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	124 Participants n=373 Participants • Sex data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=176 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	0 Participants n=197 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	0 Participants n=373 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)
Race (NIH/OMB) Asian	5 Participants n=176 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	3 Participants n=197 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	8 Participants n=373 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=176 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	0 Participants n=197 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	0 Participants n=373 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)
Race (NIH/OMB) Black or African American	0 Participants n=176 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	0 Participants n=197 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	0 Participants n=373 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)
Race (NIH/OMB) White	167 Participants n=176 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	189 Participants n=197 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	356 Participants n=373 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)
Race (NIH/OMB) More than one race	0 Participants n=176 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	1 Participants n=197 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	1 Participants n=373 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=176 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	4 Participants n=197 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)	8 Participants n=373 Participants • Ethnicity data are provide for mITT Population that includes all subjects who provided informed consent, were randomised and received at least one dose or partial dose of study drug (summarised by randomised treatment)
Region of Enrollment Greece	8 participants n=177 Participants	9 participants n=200 Participants	17 participants n=377 Participants
Region of Enrollment New Zealand	6 participants n=177 Participants	13 participants n=200 Participants	19 participants n=377 Participants
Region of Enrollment Netherlands	1 participants n=177 Participants	0 participants n=200 Participants	1 participants n=377 Participants
Region of Enrollment Belgium	0 participants n=177 Participants	2 participants n=200 Participants	2 participants n=377 Participants
Region of Enrollment Italy	23 participants n=177 Participants	30 participants n=200 Participants	53 participants n=377 Participants
Region of Enrollment United Kingdom	18 participants n=177 Participants	15 participants n=200 Participants	33 participants n=377 Participants
Region of Enrollment Israel	19 participants n=177 Participants	22 participants n=200 Participants	41 participants n=377 Participants
Region of Enrollment Australia	33 participants n=177 Participants	30 participants n=200 Participants	63 participants n=377 Participants
Region of Enrollment Portugal	21 participants n=177 Participants	27 participants n=200 Participants	48 participants n=377 Participants
Region of Enrollment Switzerland	1 participants n=177 Participants	0 participants n=200 Participants	1 participants n=377 Participants
Region of Enrollment Germany	32 participants n=177 Participants	33 participants n=200 Participants	65 participants n=377 Participants
Region of Enrollment Spain	15 participants n=177 Participants	19 participants n=200 Participants	34 participants n=377 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The Modified ITT (mITT) Population will comprise all subjects who provided informed consent, were randomised and received at least 1 dose or partial dose of the IMP.

Outcome measures

Outcome measures
Measure	CMS (Colistimethate Sodium) n=176 Participants Inhaled colistimethate sodium twice daily. The active pharmaceutical ingredient consisting of pure CMS one million international units (MIU) / 80 mg of CMS / 33 mg colistin base activity (CBA) was provided as a powder for nebuliser solution in 10R International Organization for Standardization (ISO) glass vials. CMS: 1 MIU equivalent to 80 mg colistimethate sodium diluted in 1 mL saline solution 0.45%. Investigational Medicinal Product (IMP) glass vials were shrink wrapped in opaque white plastic and provided in boxes of 30 vials (two weeks of b.i.d dosing). The 1 MIU/mL CMS/0.45% saline solution was transferred from the glass vial into a specific nebuliser system fitted with a 0.3 mL medication chamber, for administration by inhalation. This delivered a nominal dose of 0.3 MIU/24 mg CMS (\~10 mg CBA) from the device. The first dose of the IMP was administered at the site under the supervision of the site staff and subjects were instructed how to prepare and self-administer the IMP at home via a specific nebuliser system, b.i.d (morning and evening) over a period of 12 months. At least 10 minutes (min) before each administration, an inhaled short-acting bronchodilator (e.g., salbutamol /albuterol), supplied by the Sponsor, could be taken to improve tolerability.	Placebo n=197 Participants Saline solution inhaled twice daily, provided and administered at the same way of the IMP. Placebo: 1 ml saline solution 0.45%. the placebo was made up of identical empty glass vials to which the same saline diluent was added in exactly the same way as the reconstitution of the active treatment by injecting the diluent through the rubber stopper. The glass vials were shrink wrapped with opaque white plastic to maintain the blind.
Mean Annual Non-cystic Fibrosis Bronchiectasis (NCFB) Pulmonary Exacerbation Rate	0.580 number of Pulmonary Exacerbations The CIs of the LS Mean NCFB pulmonary exacerbation annual rates are infinite in both the CMS and placebo groups due to the SEs being not-estimable. (the low numbers of subjects and/or events in some countries led to the LS Means being not-estimable).	0.948 number of Pulmonary Exacerbations The CIs of the LS Mean NCFB pulmonary exacerbation annual rates are infinite in both the CMS and placebo groups due to the SEs being not-estimable. (the low numbers of subjects and/or events in some countries led to the LS Means being not-estimable).

Adverse Events

CMS (Colistimethate Sodium) (SAF)

Serious events: 31 serious events

Other events: 142 other events

Deaths: 1 deaths

Placebo (SAF)

Serious events: 46 serious events

Other events: 159 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	CMS (Colistimethate Sodium) (SAF) n=176 participants at risk Inhaled colistimethate sodium twice daily. The active pharmaceutical ingredient consisting of pure CMS one million international units (MIU) / 80 mg of CMS / 33 mg colistin base activity (CBA) was provided as a powder for nebuliser solution in 10R International Organization for Standardization (ISO) glass vials. CMS: 1 MIU equivalent to 80 mg colistimethate sodium diluted in 1 mL saline solution 0.45%. Investigational Medicinal Product (IMP) glass vials were shrink wrapped in opaque white plastic and provided in boxes of 30 vials (two weeks of b.i.d dosing). The 1 MIU/mL CMS/0.45% saline solution was transferred from the glass vial into a specific nebulizer system fitted with a 0.3 mL medication chamber, for administration by inhalation. This delivered a nominal dose of 0.3 MIU/24 mg CMS (\~10 mg CBA) from the device. The first dose of the IMP was administered at the site under the supervision of the site staff and subjects were instructed how to prepare and self-administer the IMP at home via a specific nebulizer system, b.i.d (morning and evening) over a period of 12 months. At least 10 minutes (min) before each administration, an inhaled short-acting bronchodilator (e.g., salbutamol /albuterol), supplied by the Sponsor, could be taken to improve tolerability.	Placebo (SAF) n=197 participants at risk Saline solution inhaled twice daily, provided and administered at the same way of the IMP. Placebo: 1 ml saline solution 0.45%. The placebo was made up of identical empty glass vials to which the same saline diluent was added in exactly the same way as the reconstitution of the active treatment by injecting the diluent through the rubber stopper. The glass vials were shrink wrapped with opaque white plastic to maintain the blind.
Infections and infestations Infective exacerbation of bronchiectasis	38.1% 67/176 • Number of events 110 • All AEs occurring from the day of the first IMP administration, i.e. Visit 2 (day 0), up to the follow-up (54 weeks after the beginning of the trial), when follow-up phone call took place. An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.	55.8% 110/197 • Number of events 196 • All AEs occurring from the day of the first IMP administration, i.e. Visit 2 (day 0), up to the follow-up (54 weeks after the beginning of the trial), when follow-up phone call took place. An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
Respiratory, thoracic and mediastinal disorders Cough	11.9% 21/176 • Number of events 24 • All AEs occurring from the day of the first IMP administration, i.e. Visit 2 (day 0), up to the follow-up (54 weeks after the beginning of the trial), when follow-up phone call took place. An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.	9.6% 19/197 • Number of events 19 • All AEs occurring from the day of the first IMP administration, i.e. Visit 2 (day 0), up to the follow-up (54 weeks after the beginning of the trial), when follow-up phone call took place. An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.5% 22/176 • Number of events 34 • All AEs occurring from the day of the first IMP administration, i.e. Visit 2 (day 0), up to the follow-up (54 weeks after the beginning of the trial), when follow-up phone call took place. An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.	8.1% 16/197 • Number of events 19 • All AEs occurring from the day of the first IMP administration, i.e. Visit 2 (day 0), up to the follow-up (54 weeks after the beginning of the trial), when follow-up phone call took place. An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
Respiratory, thoracic and mediastinal disorders Haemoptysis	5.1% 9/176 • Number of events 19 • All AEs occurring from the day of the first IMP administration, i.e. Visit 2 (day 0), up to the follow-up (54 weeks after the beginning of the trial), when follow-up phone call took place. An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.	9.6% 19/197 • Number of events 33 • All AEs occurring from the day of the first IMP administration, i.e. Visit 2 (day 0), up to the follow-up (54 weeks after the beginning of the trial), when follow-up phone call took place. An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
Respiratory, thoracic and mediastinal disorders Sputum increased	7.4% 13/176 • Number of events 13 • All AEs occurring from the day of the first IMP administration, i.e. Visit 2 (day 0), up to the follow-up (54 weeks after the beginning of the trial), when follow-up phone call took place. An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.	3.6% 7/197 • Number of events 9 • All AEs occurring from the day of the first IMP administration, i.e. Visit 2 (day 0), up to the follow-up (54 weeks after the beginning of the trial), when follow-up phone call took place. An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
Gastrointestinal disorders Diarrhoea	6.8% 12/176 • Number of events 12 • All AEs occurring from the day of the first IMP administration, i.e. Visit 2 (day 0), up to the follow-up (54 weeks after the beginning of the trial), when follow-up phone call took place. An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.	2.5% 5/197 • Number of events 5 • All AEs occurring from the day of the first IMP administration, i.e. Visit 2 (day 0), up to the follow-up (54 weeks after the beginning of the trial), when follow-up phone call took place. An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
Nervous system disorders Headache	2.3% 4/176 • Number of events 4 • All AEs occurring from the day of the first IMP administration, i.e. Visit 2 (day 0), up to the follow-up (54 weeks after the beginning of the trial), when follow-up phone call took place. An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.	5.6% 11/197 • Number of events 13 • All AEs occurring from the day of the first IMP administration, i.e. Visit 2 (day 0), up to the follow-up (54 weeks after the beginning of the trial), when follow-up phone call took place. An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.

Additional Information

Michela Meroni - Clinical Trial Manager

Zambon S.p.A.

Phone: +39 02 665241

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place