Trial Outcomes & Findings for Evaluation of the Efficacy and Safety of MV130 in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01842360)

NCT ID: NCT01842360

Last Updated: 2025-10-02

Results Overview

Comparison in the number of COPD exacerbations in the two study groups in the 18-month study period.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 198 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2025-10-02

Participant Flow

Participant milestones

Measure	MV130 The participants will receive daily dose of MV130 during 12 months MV130: The participants will receive daily dose of MV130 during 12 months	Placebo The participants will receive daily dose of placebo during 12 months Placebo: The participants will receive daily dose of placebo during 12 months
Overall Study STARTED	97	101
Overall Study COMPLETED	63	79
Overall Study NOT COMPLETED	34	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Efficacy and Safety of MV130 in Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Measure	MV130 n=97 Participants The participants will receive daily dose of MV130 during 12 months MV130: The participants will receive daily dose of MV130 during 12 months	Placebo n=101 Participants The participants will receive daily dose of placebo during 12 months Placebo: The participants will receive daily dose of placebo during 12 months	Total n=198 Participants Total of all reporting groups
Age, Continuous	68.0 years STANDARD_DEVIATION 9.3 • n=5 Participants	70.0 years STANDARD_DEVIATION 8.9 • n=7 Participants	69.0 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	25 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants	76 Participants n=7 Participants	154 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	97 Participants n=5 Participants	100 Participants n=7 Participants	197 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Weight	76.2 kilograms STANDARD_DEVIATION 15.6 • n=5 Participants	73.5 kilograms STANDARD_DEVIATION 15.2 • n=7 Participants	74.8 kilograms STANDARD_DEVIATION 15.4 • n=5 Participants
BMI	27.8 kg/m^2 STANDARD_DEVIATION 4.5 • n=5 Participants	27.5 kg/m^2 STANDARD_DEVIATION 4.7 • n=7 Participants	27.6 kg/m^2 STANDARD_DEVIATION 4.6 • n=5 Participants
FEV1	55.7 liters STANDARD_DEVIATION 14.5 • n=5 Participants	56.9 liters STANDARD_DEVIATION 14.6 • n=7 Participants	56.3 liters STANDARD_DEVIATION 14.5 • n=5 Participants
Smoking status	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
CAT	13.9 Score STANDARD_DEVIATION 6.8 • n=5 Participants	13.2 Score STANDARD_DEVIATION 7.2 • n=7 Participants	13.5 Score STANDARD_DEVIATION 6.2 • n=5 Participants
VAS	7.1 scores on a scale STANDARD_DEVIATION 1.6 • n=5 Participants	7.0 scores on a scale STANDARD_DEVIATION 1.7 • n=7 Participants	7.0 scores on a scale STANDARD_DEVIATION 1.6 • n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Comparison in the number of COPD exacerbations in the two study groups in the 18-month study period.

Outcome measures

Measure	Active - MV130 n=97 Participants The participants will receive daily dose of MV130 during 12 months sublingually. MV130: The participants will receive daily dose of MV130 during 12 months sublingually.	Placebo n=101 Participants The participants will receive daily dose of placebo during 12 months sublingually. Placebo: The participants will receive daily dose of placebo during 12 months sublingually.
Number of COPD Exacerbations.	2.0 number of exacerbations Interval 1.0 to 3.0	3.0 number of exacerbations Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: 18 months

Incidence is the number of new events per total participants in the sample population.

Outcome measures

Measure	Active - MV130 n=97 Participants The participants will receive daily dose of MV130 during 12 months sublingually. MV130: The participants will receive daily dose of MV130 during 12 months sublingually.	Placebo n=101 Participants The participants will receive daily dose of placebo during 12 months sublingually. Placebo: The participants will receive daily dose of placebo during 12 months sublingually.
Change in the Rate of COPD Exacerbations.	1.86 events per participant-year	2.67 events per participant-year

SECONDARY outcome

Timeframe: 18 months

The severity of exacerbations was to be measured by the consumption of health care resources:

Emergency Department/Hospitalisation/Intensive Care Unit/Consultations visits, as follows:

ICU hospitalisation 4 points Hospitalisation 3 points Emergency room visit 2 points Consultation resulting in change in usual treatment 1 point

Outcome measures

Measure	Active - MV130 n=97 Participants The participants will receive daily dose of MV130 during 12 months sublingually. MV130: The participants will receive daily dose of MV130 during 12 months sublingually.	Placebo n=101 Participants The participants will receive daily dose of placebo during 12 months sublingually. Placebo: The participants will receive daily dose of placebo during 12 months sublingually.
Change in Severity of COPD Exacerbations.	1.0 points Interval 0.0 to 5.0	3.0 points Interval 1.0 to 23.0

SECONDARY outcome

Timeframe: 18 months

For reference, median survival or event-free times are reported with the 95% CI of the median.

Outcome measures

Measure	Active - MV130 n=97 Participants The participants will receive daily dose of MV130 during 12 months sublingually. MV130: The participants will receive daily dose of MV130 during 12 months sublingually.	Placebo n=101 Participants The participants will receive daily dose of placebo during 12 months sublingually. Placebo: The participants will receive daily dose of placebo during 12 months sublingually.
Time Elapsed Between Start of Treatment and First COPD Exacerbation.	6.35 number of months Interval 4.41 to 9.0	4.42 number of months Interval 3.38 to 6.61

SECONDARY outcome

Timeframe: 18 months

The use of drugs will be calculated using the following index:

• antibiotics: 1 point
• inhaled corticosteroids: 2 points
• systemic corticosteroids: 3 points

Outcome measures

Measure	Active - MV130 n=97 Participants The participants will receive daily dose of MV130 during 12 months sublingually. MV130: The participants will receive daily dose of MV130 during 12 months sublingually.	Placebo n=101 Participants The participants will receive daily dose of placebo during 12 months sublingually. Placebo: The participants will receive daily dose of placebo during 12 months sublingually.
Use of Drugs (Antibiotics, Corticosteroids, Etc).	24.0 points Interval 0.0 to 71.0	40.0 points Interval 9.0 to 112.0

SECONDARY outcome

Timeframe: 18 months

The same patient could have more than one hospitalizations.

Outcome measures

Measure	Active - MV130 n=97 Participants The participants will receive daily dose of MV130 during 12 months sublingually. MV130: The participants will receive daily dose of MV130 during 12 months sublingually.	Placebo n=101 Participants The participants will receive daily dose of placebo during 12 months sublingually. Placebo: The participants will receive daily dose of placebo during 12 months sublingually.
Number of Hospitalizations Due to a COPD Exacerbation.	0.0 number of hospitalizations Interval 0.0 to 0.0	0.0 number of hospitalizations Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 18 months

Number of days of hospitalization per patient were recorded. The same patient could have more than one hospitalization.

Outcome measures

Measure	Active - MV130 n=97 Participants The participants will receive daily dose of MV130 during 12 months sublingually. MV130: The participants will receive daily dose of MV130 during 12 months sublingually.	Placebo n=101 Participants The participants will receive daily dose of placebo during 12 months sublingually. Placebo: The participants will receive daily dose of placebo during 12 months sublingually.
Days of Hospitalization Due to a COPD Exacerbation.	0.0 number of days Interval 0.0 to 0.0	0.0 number of days Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: 18 months

Number of individual visits were recorded per patient. One patient could have multiple visits.

Outcome measures

Measure	Active - MV130 n=97 Participants The participants will receive daily dose of MV130 during 12 months sublingually. MV130: The participants will receive daily dose of MV130 during 12 months sublingually.	Placebo n=101 Participants The participants will receive daily dose of placebo during 12 months sublingually. Placebo: The participants will receive daily dose of placebo during 12 months sublingually.
Number of Visits to the Emergency Room.	0.0 number of visits Interval 0.0 to 0.0	0.0 number of visits Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 18 months.

Number of consultations per patient. One patient could have multiple consultations.

Outcome measures

Measure	Active - MV130 n=97 Participants The participants will receive daily dose of MV130 during 12 months sublingually. MV130: The participants will receive daily dose of MV130 during 12 months sublingually.	Placebo n=101 Participants The participants will receive daily dose of placebo during 12 months sublingually. Placebo: The participants will receive daily dose of placebo during 12 months sublingually.
Number of Unscheduled Medical Consultations Due to COPD	0.0 number of consultations Interval 0.0 to 0.0	0.0 number of consultations Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 18 months

COPD Assessment Test per patient determined by an adapted version of the specific COPD Assessment Test. Minimum value is 0 (better) and maximum value is 40 (worse). The change between two or more time points is reported. Change between baseline and 18 months in shown.

Outcome measures

Measure	Active - MV130 n=97 Participants The participants will receive daily dose of MV130 during 12 months sublingually. MV130: The participants will receive daily dose of MV130 during 12 months sublingually.	Placebo n=101 Participants The participants will receive daily dose of placebo during 12 months sublingually. Placebo: The participants will receive daily dose of placebo during 12 months sublingually.
Health Related Quality of Life.	-1.5 score on a scale Interval -7.0 to 1.5	-1.0 score on a scale Interval -5.0 to 3.0

SECONDARY outcome

Timeframe: 18 months

Healthcare resource utilization was assessed as the sum of:

• Complementary tests
• Programmed visits to the specialist
• Total number of visits to the specialist
• Non-programmed visits to the specialist
• ICU hospitalization days
• Visits to the emergency room
• Days hospitalized
• Sum of antibiotics
• Number of visits to General Practitioner
• Sum of oral corticosteroids
• Number of telephone calls to the GP
• Sum of inhalers
• Home visits
• Sum of antipyretics

Total number of healthcare resources used during COPD exacerbation episodes. Data were summarized per treatment group and reported as total counts and percent differences. No baseline or monetary data were collected

Outcome measures

Measure	Active - MV130 n=97 Participants The participants will receive daily dose of MV130 during 12 months sublingually. MV130: The participants will receive daily dose of MV130 during 12 months sublingually.	Placebo n=101 Participants The participants will receive daily dose of placebo during 12 months sublingually. Placebo: The participants will receive daily dose of placebo during 12 months sublingually.
Healthcare Resource Utilization During COPD Exacerbations	5202 Total number of resource units	8231 Total number of resource units

SECONDARY outcome

Timeframe: 18 months

Total number of adverse events in Active (MV130) and Placebo groups were compared.

Outcome measures

Measure	Active - MV130 n=97 Participants The participants will receive daily dose of MV130 during 12 months sublingually. MV130: The participants will receive daily dose of MV130 during 12 months sublingually.	Placebo n=101 Participants The participants will receive daily dose of placebo during 12 months sublingually. Placebo: The participants will receive daily dose of placebo during 12 months sublingually.
Adverse Events and Overall Tolerability (Adverse Reactions).	116 number of events	113 number of events

POST_HOC outcome

Timeframe: 6 month follow-up period

Number of Participants who were free of exacerbation during the 6 month follow-up period were compared between active and placebo groups.

Outcome measures

Measure	Active - MV130 n=94 Participants The participants will receive daily dose of MV130 during 12 months sublingually. MV130: The participants will receive daily dose of MV130 during 12 months sublingually.	Placebo n=97 Participants The participants will receive daily dose of placebo during 12 months sublingually. Placebo: The participants will receive daily dose of placebo during 12 months sublingually.
Number of Exacerbation-Free Participants During the Follow-up Period (Month 12 to Month 18).	67 Participants	47 Participants

POST_HOC outcome

Timeframe: 3, 6, 12, 18 months and follow-up.

Cumulated rate of COPD exacerbations per participant, graded by severity, at different time points (change from baseline to 3, 6, 12, and 18 months and follow-up (change from month 12 to 18)).

Outcome measures

Measure	Active - MV130 n=97 Participants The participants will receive daily dose of MV130 during 12 months sublingually. MV130: The participants will receive daily dose of MV130 during 12 months sublingually.	Placebo n=101 Participants The participants will receive daily dose of placebo during 12 months sublingually. Placebo: The participants will receive daily dose of placebo during 12 months sublingually.
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Severe exacerbations - 3 months	0.0 number of exacerbations Interval 0.0 to 0.0	0.0 number of exacerbations Interval 0.0 to 0.0
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Severe exacerbations - 12 months	0.0 number of exacerbations Interval 0.0 to 0.0	0.0 number of exacerbations Interval 0.0 to 1.0
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Severe exacerbations - 18 months	0.0 number of exacerbations Interval 0.0 to 0.0	0.0 number of exacerbations Interval 0.0 to 1.0
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Moderate exacerbations - 18 months	1.0 number of exacerbations Interval 0.0 to 2.0	1.0 number of exacerbations Interval 0.0 to 4.0
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Moderate exacerbations - Follow up	0.0 number of exacerbations Interval 0.0 to 1.0	0.0 number of exacerbations Interval 0.0 to 1.0
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Severe exacerbations - 6 months	0.0 number of exacerbations Interval 0.0 to 0.0	0.0 number of exacerbations Interval 0.0 to 0.0
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Severe exacerbations - Follow up	0.0 number of exacerbations Interval 0.0 to 0.0	0.0 number of exacerbations Interval 0.0 to 0.0
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Moderate exacerbations - 12 months	1.0 number of exacerbations Interval 0.0 to 1.0	1.0 number of exacerbations Interval 0.0 to 3.0
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Mild exacerbations - 3 months	0.0 number of exacerbations Interval 0.0 to 0.0	0.0 number of exacerbations Interval 0.0 to 0.0
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Mild exacerbations - 6 months	0.0 number of exacerbations Interval 0.0 to 0.0	0.0 number of exacerbations Interval 0.0 to 0.0
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Mild exacerbations - 12 months	0.0 number of exacerbations Interval 0.0 to 0.0	0.0 number of exacerbations Interval 0.0 to 0.0
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Mild exacerbations - 18 months	0.0 number of exacerbations Interval 0.0 to 0.0	0.0 number of exacerbations Interval 0.0 to 0.0
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Mild exacerbations - Follow up	0.0 number of exacerbations Interval 0.0 to 0.0	0.0 number of exacerbations Interval 0.0 to 0.0
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Moderate exacerbations - 3 months	0.0 number of exacerbations Interval 0.0 to 0.0	0.0 number of exacerbations Interval 0.0 to 1.0
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Moderate exacerbations - 6 months	0.0 number of exacerbations Interval 0.0 to 1.0	0.0 number of exacerbations Interval 0.0 to 1.0
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Total - 3 months	0.0 number of exacerbations Interval 0.0 to 1.0	0.0 number of exacerbations Interval 0.0 to 1.0
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Total - 6 months	1.0 number of exacerbations Interval 0.0 to 1.0	1.0 number of exacerbations Interval 0.0 to 2.0
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Total - 12 months	1.0 number of exacerbations Interval 0.0 to 2.0	2.0 number of exacerbations Interval 1.0 to 4.0
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Total - 18 months	2.0 number of exacerbations Interval 1.0 to 3.0	3.0 number of exacerbations Interval 1.0 to 5.0
Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points. Total - Follow up	0.0 number of exacerbations Interval 0.0 to 1.0	1.0 number of exacerbations Interval 0.0 to 1.0

Adverse Events

MV130

Serious events: 9 serious events

Other events: 26 other events

Deaths: 1 deaths

Placebo

Serious events: 12 serious events

Other events: 13 other events

Deaths: 2 deaths

Serious adverse events

Measure	MV130 n=97 participants at risk The participants will receive daily dose of MV130 during 12 months MV130: The participants will receive daily dose of MV130 during 12 months	Placebo n=101 participants at risk The participants will receive daily dose of placebo during 12 months Placebo: The participants will receive daily dose of placebo during 12 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) metastases to central nervous system	0.00% 0/97 • from enrollment until end of follow-up, 18 months	0.99% 1/101 • from enrollment until end of follow-up, 18 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.00% 0/97 • from enrollment until end of follow-up, 18 months	0.99% 1/101 • from enrollment until end of follow-up, 18 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.0% 1/97 • from enrollment until end of follow-up, 18 months	0.00% 0/101 • from enrollment until end of follow-up, 18 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	1.0% 1/97 • from enrollment until end of follow-up, 18 months	0.00% 0/101 • from enrollment until end of follow-up, 18 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Aenocarcinoma pancreas	1.0% 1/97 • from enrollment until end of follow-up, 18 months	0.00% 0/101 • from enrollment until end of follow-up, 18 months
Cardiac disorders Unstable angina	1.0% 1/97 • from enrollment until end of follow-up, 18 months	0.00% 0/101 • from enrollment until end of follow-up, 18 months
Cardiac disorders Acute myocardial infarction	1.0% 1/97 • from enrollment until end of follow-up, 18 months	0.00% 0/101 • from enrollment until end of follow-up, 18 months
Cardiac disorders Cardiac failure congestive	1.0% 1/97 • from enrollment until end of follow-up, 18 months	0.00% 0/101 • from enrollment until end of follow-up, 18 months
Cardiac disorders Cardiac failure	0.00% 0/97 • from enrollment until end of follow-up, 18 months	0.99% 1/101 • from enrollment until end of follow-up, 18 months
Surgical and medical procedures Surgery	0.00% 0/97 • from enrollment until end of follow-up, 18 months	0.99% 1/101 • from enrollment until end of follow-up, 18 months
Nervous system disorders Petit mal epilepsy	0.00% 0/97 • from enrollment until end of follow-up, 18 months	0.99% 1/101 • from enrollment until end of follow-up, 18 months
Nervous system disorders Cerebrovascular accident	0.00% 0/97 • from enrollment until end of follow-up, 18 months	2.0% 2/101 • from enrollment until end of follow-up, 18 months
Nervous system disorders Haemorrhage intracranial	1.0% 1/97 • from enrollment until end of follow-up, 18 months	0.00% 0/101 • from enrollment until end of follow-up, 18 months
Gastrointestinal disorders Apendicitis	0.00% 0/97 • from enrollment until end of follow-up, 18 months	0.99% 1/101 • from enrollment until end of follow-up, 18 months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/97 • from enrollment until end of follow-up, 18 months	0.99% 1/101 • from enrollment until end of follow-up, 18 months
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.0% 1/97 • from enrollment until end of follow-up, 18 months	0.99% 1/101 • from enrollment until end of follow-up, 18 months
Respiratory, thoracic and mediastinal disorders Pulmonary aspergillosis	0.00% 0/97 • from enrollment until end of follow-up, 18 months	0.99% 1/101 • from enrollment until end of follow-up, 18 months
Infections and infestations Mycobacterium avium complex infection	0.00% 0/97 • from enrollment until end of follow-up, 18 months	0.99% 1/101 • from enrollment until end of follow-up, 18 months
Infections and infestations Cytomegalovirus infection	1.0% 1/97 • from enrollment until end of follow-up, 18 months	0.00% 0/101 • from enrollment until end of follow-up, 18 months

Other adverse events

Measure	MV130 n=97 participants at risk The participants will receive daily dose of MV130 during 12 months MV130: The participants will receive daily dose of MV130 during 12 months	Placebo n=101 participants at risk The participants will receive daily dose of placebo during 12 months Placebo: The participants will receive daily dose of placebo during 12 months
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	5.2% 5/97 • from enrollment until end of follow-up, 18 months	7.9% 8/101 • from enrollment until end of follow-up, 18 months
Renal and urinary disorders Urinary tract infection	8.2% 8/97 • from enrollment until end of follow-up, 18 months	3.0% 3/101 • from enrollment until end of follow-up, 18 months
Musculoskeletal and connective tissue disorders Arthralgia	6.2% 6/97 • from enrollment until end of follow-up, 18 months	0.99% 1/101 • from enrollment until end of follow-up, 18 months
Musculoskeletal and connective tissue disorders Back pain	7.2% 7/97 • from enrollment until end of follow-up, 18 months	0.99% 1/101 • from enrollment until end of follow-up, 18 months

Additional Information

Miguel Casanovas

Inmunotek S.L

Phone: 34691490175

Email: mcasanovas@inmunotek.com

Results disclosure agreements

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