Trial Outcomes & Findings for Effects of Ventavis in Patients With Pulmonary Hypertension (PH) Secondary to Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01437878)

NCT ID: NCT01437878

Last Updated: 2015-11-20

Results Overview

Change from baseline to week 4 in endurance time during constant work rate exercise testing

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: Baseline to week 4
• Results posted on: 2015-11-20

Participant Flow

Patients were screened at 4 centres in the US, one centre in France, and one site in Spain. First patient, first visit was 1 March 2012 and last patient, last visit was 30 November 2012.

A total of 22 patients were screened for the study, of these 20 were not randomized because they did not meet the selection criteria.

Participant milestones

Measure	Iloprost single dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks	Placebo matching placebo using the power disc-6 with I-neb AAD system Placebo: matching placebo
Overall Study STARTED	1	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Iloprost single dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks	Placebo matching placebo using the power disc-6 with I-neb AAD system Placebo: matching placebo
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Effects of Ventavis in Patients With Pulmonary Hypertension (PH) Secondary to Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Measure	Iloprost n=1 Participants single dose inhalation using the power disc-6 with I-neb AAD system Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks	Placebo n=1 Participants matching placebo using the power disc-6 with I-neb AAD system Placebo: matching placebo	Total n=2 Participants Total of all reporting groups
Age, Customized Age 64 years	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Age, Customized Age 74 years	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment France	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to week 4

Population: The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.

Change from baseline to week 4 in endurance time during constant work rate exercise testing

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 24 hours post-EOT, approximately 4 weeks

Population: Total population

Treatment-emergent adverse events up to 24 hours post-end of treatment (EOT), approximately 4 weeks

Outcome measures

Measure	Iloprost n=1 Participants single dose inhalation using the power disc-6 with I-neb AAD system Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks	Placebo n=1 Participants matching placebo using the power disc-6 with I-neb AAD system Placebo: matching placebo
Participants With Treatment-emergent Adverse Events	0 participants	0 participants

SECONDARY outcome

Timeframe: 15 minutes

Population: The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.

On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 15 minutes

Population: The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.

On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 15 minutes

Population: The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.

On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 15 minutes

Population: The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.

On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 15 minutes

Population: The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.

On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 15 minutes

Population: The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.

On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 15 minutes

Population: The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.

On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to week 4

Population: The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.

Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to week 4

Population: The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.

Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to week 4

Population: The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.

Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to week 4

Population: The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.

Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to week 4

Population: The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.

Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to week 4

Population: The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.

Change from baseline to week 4. Heart rate was measured during incremental and constant work rate exercise testing.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to week 4

Population: The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.

Change from baseline to week 4. Arterial oxygen was determined by pulse oximetry during incremental and constant work rate exercise testing.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to week 4

Population: The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.

Change from baseline to week 4. Tidal volume was measured during incremental and constant work rate exercise testing.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to week 4

Population: The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.

Change from baseline to week 4. Minute ventilation was measured during incremental and constant work rate exercise testing.

Outcome measures

Outcome data not reported

Adverse Events

Iloprost

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Maziar Assadi Gehr

Actelion Pharmaceutical Ltd

Phone: +41 61 565 5525

Email: maziar.assadi-gehr@actelion.com

Results disclosure agreements

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

Restriction type: OTHER