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Trial record 8 of 8 for:    savara

Inhaled Vancomycin Tolerability, Safety and Pharmacokinetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01537666
Recruitment Status : Completed
First Posted : February 23, 2012
Results First Posted : March 4, 2014
Last Update Posted : March 31, 2014
Sponsor:
Collaborator:
INC Research Limited
Information provided by (Responsible Party):
Savara Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Healthy
Cystic Fibrosis
Interventions Drug: AeroVanc
Drug: IV vancomycin hydrochloride
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aerovanc 16 mg (Subset IV Vancomycin) in Healthy Volunteers AeroVanc 32 mg (Subset IV Vancomycin) in Healthy Volunteers AeroVanc 80 mg (Subset IV Vancomycin) in Healthy Volunteers AeroVanc 32 and 80 mg in CF Patients
Hide Arm/Group Description AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall) AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall) AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall) AeroVanc : Vancomycin hydrochloride dry powder for inhalation
Period Title: Overall Study
Started 6 [1] 6 [1] 6 [1] 7 [2]
Completed 6 6 6 7 [3]
Not Completed 0 0 0 0
[1]
2 of these 6 also received a single 250 mg IV dose of vancomycin at least 72 hours after AeroVanc.
[2]
5 of 7 patients received a 32 mg dose of AeroVanc followed by a dose of 80 mg at least 1 week later.
[3]
1 patient withdrew after a 32 mg dose and was replaced by a patient who only received an 80 mg dose.
Arm/Group Title Aerovanc 16 mg (Subset IV Vancomycin) in Healthy Volunteers AeroVanc 32 mg (Subset IV Vancomycin) in Healthy Volunteers AeroVanc 80 mg (Subset IV Vancomycin) in Healthy Volunteers AeroVanc 32 and 80 mg in CF Patients Total
Hide Arm/Group Description AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall) AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall) AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall) AeroVanc : Vancomycin hydrochloride dry powder for inhalation Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 7 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 7 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
6
 100.0%
6
 100.0%
7
 100.0%
25
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 7 participants 25 participants
28.2  (10.5) 24.7  (3.7) 22.2  (2.8) 29.7  (7.8) 26.3  (7.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 7 participants 25 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
3
  42.9%
3
  12.0%
Male
6
 100.0%
6
 100.0%
6
 100.0%
4
  57.1%
22
  88.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 6 participants 6 participants 6 participants 7 participants 25 participants
6 6 6 7 25
1.Primary Outcome
Title Safety and Tolerability - Number of Participants With Treatment Emergent Adverse Events (TEAEs = Adverse Events That Started During or After the First Dose of Study Drug)
Hide Description Each participant was monitored regularly for Adverse Events (AEs) throughout the study. The Investigator or designee enquired about AEs by asking participants non-leading questions such as: "How do you feel?" or "Have you had any (other) medical problems since your last visit/assessment?" Additionally, several safety procedures (physical examinations, vital signs, safety laboratory tests, 12-lead ECGs, and spirometry) were conducted on participants at regular intervals. All AEs reported spontaneously by participants or in response to questioning or observation by the Investigator, including those related to safety procedures, were recorded. For each AE, the Investigator recorded the following assessments: seriousness, severity (Mild, Moderate, or Severe), and relationship to study drug (Not Related, Remote, Possible, Probable, or Highly Probable). AEs were considered drug-related if given a relationship of Possible, Probable, or Highly Probable.
Time Frame Healthy volunteers = 2 weeks; CF Patients = 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
All 18 healthy volunteers who received single doses of AeroVanc, 6 of which also received a single dose of IV vancomycin. All 7 Cystic Fibrosis patients who received at least one single dose of AeroVanc.
Arm/Group Title AeroVanc 16 mg in Healthy Volunteers AeroVanc 32 mg in Healthy Volunteers AeroVanc 80 mg in Healthy Volunteers IV Vancomycin 250 mg in Healthy Volunteers AeroVanc 32 mg in Cystic Fibrosis Patients AeroVanc 80 mg in Cystic Fibrosis Patients
Hide Arm/Group Description:
Single inhaled dose of 16 mg AeroVanc in health volunteers.
Single inhaled dose of 32 mg AeroVanc in health volunteers.
Single inhaled dose of 80 mg AeroVanc in health volunteers.
Single IV dose of Vancomycin 250 mg in Healthy Volunteers. Group comprised of 2 subjects from each of the AeroVanc in Healthy Volunteers groups.
Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
Overall Number of Participants Analyzed 6 6 6 6 6 6
Measure Type: Number
Unit of Measure: participants
Total with at least one TEAE 2 5 2 2 6 5
Subset of total with drug-related TEAEs 2 3 2 1 4 4
Subset of total with severe TEAEs 0 0 0 0 1 0
Subset of total with severe, drug-related TEAEs 0 0 0 0 0 0
Subset of total with serious TEAEs 0 0 0 0 1 0
Subset of total with serious, drug-related TEAEs 0 0 0 0 0 0
2.Secondary Outcome
Title Plasma Pharmacokinetics - Elimination Half Life (t½)
Hide Description

Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.

Half-life is the time it takes for the concentration of drug to decline by 50%.

Time Frame Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.
Arm/Group Title Aerovanc 16 mg in Healthy Volunteers AeroVanc 32 mg in Healthy Volunteers AeroVanc 80 mg in Healthy Volunteers IV Vancomycin 250 mg in Healthy Volunteers
Hide Arm/Group Description:
AeroVanc : Vancomycin hydrochloride dry powder for inhalation
AeroVanc : Vancomycin hydrochloride dry powder for inhalation
AeroVanc : Vancomycin hydrochloride dry powder for inhalation
IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: Hours
8.454  (2.017) 8.648  (0.530) 8.044  (1.296) 7.226  (1.128)
3.Secondary Outcome
Title Plasma Pharmacokinetics - Time to Reach the Maximum Plasma Concentration (Tmax)
Hide Description

Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.

Tmax is the time it takes to reach the maximum plasma concentration of a drug.

Time Frame Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.
Arm/Group Title Aerovanc 16 mg in Healthy Volunteers AeroVanc 32 mg in Healthy Volunteers AeroVanc 80 mg in Healthy Volunteers IV Vancomycin 250 mg in Healthy Volunteers
Hide Arm/Group Description:
AeroVanc : Vancomycin hydrochloride dry powder for inhalation
AeroVanc : Vancomycin hydrochloride dry powder for inhalation
AeroVanc : Vancomycin hydrochloride dry powder for inhalation
IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: Hours
2.083  (0.801) 1.833  (0.606) 1.333  (0.408) 0.917  (0.204)
4.Secondary Outcome
Title Plasma Pharmacokinetics - Maximum Plasma Concentration (Cmax)
Hide Description

Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.

Cmax is the maximum observed concentration of a drug.

Time Frame Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.
Arm/Group Title Aerovanc 16 mg in Healthy Volunteers AeroVanc 32 mg in Healthy Volunteers AeroVanc 80 mg in Healthy Volunteers IV Vancomycin 250 mg in Healthy Volunteers
Hide Arm/Group Description:
AeroVanc : Vancomycin hydrochloride dry powder for inhalation
AeroVanc : Vancomycin hydrochloride dry powder for inhalation
AeroVanc : Vancomycin hydrochloride dry powder for inhalation
IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng/ml
108.82  (33.16) 231.50  (89.64) 617.83  (230.03) 10028.33  (1767.69)
5.Secondary Outcome
Title Plasma Pharmacokinetics - Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUCt)
Hide Description

Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.

AUCt is a way of expressing the total amount of drug exposure over a specified time period.

Time Frame Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.
Arm/Group Title Aerovanc 16 mg in Healthy Volunteers AeroVanc 32 mg in Healthy Volunteers AeroVanc 80 mg in Healthy Volunteers IV Vancomycin 250 mg in Healthy Volunteers
Hide Arm/Group Description:
AeroVanc : Vancomycin hydrochloride dry powder for inhalation
AeroVanc : Vancomycin hydrochloride dry powder for inhalation
AeroVanc : Vancomycin hydrochloride dry powder for inhalation
IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: h*ng/ml
1209.644  (237.696) 2379.790  (975.410) 6257.858  (1506.939) 41027.792  (2696.013)
6.Secondary Outcome
Title Plasma Pharmacokinetics - Area Under the Plasma Concentration-time Curve From Time 0 to Infinite Time (AUCinf)
Hide Description

Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.

AUCinf is a way of estimating the total amount of drug exposure over an infinite time period.

Time Frame Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.
Arm/Group Title Aerovanc 16 mg in Healthy Volunteers AeroVanc 32 mg in Healthy Volunteers AeroVanc 80 mg in Healthy Volunteers IV Vancomycin 250 mg in Healthy Volunteers
Hide Arm/Group Description:
AeroVanc : Vancomycin hydrochloride dry powder for inhalation
AeroVanc : Vancomycin hydrochloride dry powder for inhalation
AeroVanc : Vancomycin hydrochloride dry powder for inhalation
IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: h*ng/ml
1461.407  (257.189) 3051.12  (959.14) 7135.735  (1457.921) 44356.356  (3623.420)
7.Secondary Outcome
Title Lung Pharmacokinetics - Maximum Sputum Concentration (Cmax)
Hide Description

Sputum samples were obtained from the patients with cystic fibrosis to evaluate lung pharmacokinetics of vancomycin after a single dose administration of AeroVanc.

Cmax is the maximum observed concentration of a drug.

Time Frame 1, 8 and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All CF patients who received a 32 mg dose of AeroVanc followed at least one week later by an 80 mg dose of AeroVanc (N=5). One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
Arm/Group Title AeroVanc 32 mg in Cystic Fibrosis Patients AeroVanc 80 mg in Cystic Fibrosis Patients
Hide Arm/Group Description:
Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: µg/ml
95.775  (171.544) 269.17  (510.98)
8.Secondary Outcome
Title Lung Pharmacokinetics - Minimum Sputum Concentration (Cmin)
Hide Description

Sputum samples were obtained from the patients with cystic fibrosis to evaluate lung pharmacokinetics of vancomycin after a single dose administration of AeroVanc.

Cmin is the minimum observed concentration of a drug.

Time Frame 1, 8 and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All CF patients who received a 32 mg dose of AeroVanc followed at least one week later by an 80 mg dose of AeroVanc (N=5). One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
Arm/Group Title AeroVanc 32 mg in Cystic Fibrosis Patients AeroVanc 80 mg in Cystic Fibrosis Patients
Hide Arm/Group Description:
Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: µg/ml
3.050  (3.679) 7.990  (8.066)
Time Frame All 25 subjects enrolled received at least part of their allocated study treatments and are included in the safety population. All subjects received their allocated dose, and in Part 2 of the study, 5 subjects received both the 32 mg and 80 mg doses.
Adverse Event Reporting Description AEs were grouped by system organ class and summarized by dose level at the time of onset of the AE. All AE summaries are restricted to TEAEs, defined as AEs that began on or after the start of study drug. AEs without an onset date or time were excluded from the summary tables as it was not possible to allocate to a particular treatment.
 
Arm/Group Title AeroVanc 16 mg in Healthy Volunteers AeroVanc 32 mg in Healthy Volunteers AeroVanc 80 mg in Healthy Volunteers AeroVanc 32 mg in Cystic Fibrosis Patients AeroVanc 80 mg in Cystic Fibrosis Patients IV Vancomycin 250 mg in Healthy Volunteers
Hide Arm/Group Description Single inhaled dose of 16 mg AeroVanc in health volunteers. Single inhaled dose of 32 mg AeroVanc in health volunteers. Single inhaled dose of 80 mg AeroVanc in health volunteers. Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose. Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose. Comprised of 2 patients from each of the AeroVanc in Healthy Volunteer groups.
All-Cause Mortality
AeroVanc 16 mg in Healthy Volunteers AeroVanc 32 mg in Healthy Volunteers AeroVanc 80 mg in Healthy Volunteers AeroVanc 32 mg in Cystic Fibrosis Patients AeroVanc 80 mg in Cystic Fibrosis Patients IV Vancomycin 250 mg in Healthy Volunteers
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
AeroVanc 16 mg in Healthy Volunteers AeroVanc 32 mg in Healthy Volunteers AeroVanc 80 mg in Healthy Volunteers AeroVanc 32 mg in Cystic Fibrosis Patients AeroVanc 80 mg in Cystic Fibrosis Patients IV Vancomycin 250 mg in Healthy Volunteers
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      1/6 (16.67%)      0/6 (0.00%)      0/6 (0.00%)    
Renal and urinary disorders             
AGGRAVATED RENAL COLIC  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AeroVanc 16 mg in Healthy Volunteers AeroVanc 32 mg in Healthy Volunteers AeroVanc 80 mg in Healthy Volunteers AeroVanc 32 mg in Cystic Fibrosis Patients AeroVanc 80 mg in Cystic Fibrosis Patients IV Vancomycin 250 mg in Healthy Volunteers
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/6 (33.33%)      5/6 (83.33%)      2/6 (33.33%)      6/6 (100.00%)      5/6 (83.33%)      2/6 (33.33%)    
Gastrointestinal disorders             
Diarrhoea  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Nausea  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2 1/6 (16.67%)  1 0/6 (0.00%)  0
Oral discomfort  1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
General disorders             
Chest discomfort  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Feeling hot  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Infections and infestations             
Upper respiratory tract infection  1/6 (16.67%)  1 2/6 (33.33%)  3 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1
Injury, poisoning and procedural complications             
Excoriation  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Investigations             
Forced expiratory volume decreased  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0
Liver function test abnormal  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Nervous system disorders             
Dizziness  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Headache  0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Cough  0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Dyspnoea  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Pharyngolaryngeal pain  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Respiratory disorder  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 1/6 (16.67%)  1 0/6 (0.00%)  0
Respiratory tract congestion  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 3/6 (50.00%)  3 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders             
Drug eruption  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PI cannot at any time during or after the Study make any announcement, oral presentation or publication relating to the Study, or any of the methods, results of, or conclusions from, the Study without the prior written consent of the Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Taneli Jouhikainen, MD, MBA; Chief Operating Officer
Organization: Savara Inc.
Phone: (888) 302-4876
EMail: info@savarapharma.com
Layout table for additonal information
Responsible Party: Savara Inc.
ClinicalTrials.gov Identifier: NCT01537666    
Other Study ID Numbers: SAV005-01
First Submitted: February 17, 2012
First Posted: February 23, 2012
Results First Submitted: October 30, 2013
Results First Posted: March 4, 2014
Last Update Posted: March 31, 2014