Clinical Trials Register

Summary
EudraCT Number:	2018-002806-30
Sponsor's Protocol Code Number:	PUL-042-402
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	GB - no longer in EU/EEA
Date on which this record was first entered in the EudraCT database:	2018-09-07
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2018-002806-30

A.3

Full title of the trial

A Phase 2, Single-Center, Double-Blind, Placebo-Controlled, Study of PUL-042 Inhalation Solution in Rhinovirus-induced Symptoms in Current Smokers with Gold Stage 0 Chronic Obstructive Pulmonary Disease (COPD).

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study in patients with Chronic Obstructive Pulmonary Disease (COPD) to see if a new medicine under development (PUL-042) can prevent symptoms and effects on the lungs when the patient is deliberately infected with a virus (rhinovirus) that causes the common cold.

A.4.1

Sponsor's protocol code number

PUL-042-402

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Pulmotect, Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Pulmotect, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pulmotect, Inc.
B.5.2	Functional name of contact point	Brenton Scott, PhD
B.5.3	Address:
B.5.3.1	Street Address	3900 Essex Lane, Suite 575
B.5.3.2	Town/ city	Houston, Texas
B.5.3.3	Post code	77027
B.5.3.4	Country	United States
B.5.4	Telephone number	1713579-9226
B.5.6	E-mail	bscott@pulmotect.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	PUL-042
D.3.4	Pharmaceutical form	Concentrate for nebuliser solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pam2
D.3.9.2	Current sponsor code	Pam2
D.3.9.3	Other descriptive name	Pam2CSK4
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	45
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ODN
D.3.9.2	Current sponsor code	ODN
D.3.9.3	Other descriptive name	ODN M362
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	56.0
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Inhalation solution
D.8.4	Route of administration of the placebo	Inhalation use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

GOLD (Global Initiative for Chronic Obstructive Lung Disease) stage 0 Chronic Obstructive Pulmonary Disease (COPD)

E.1.1.1

Medical condition in easily understood language

Emphysema, chronic bronchitis, and refractory (non-reversible) asthma. The disease is characterized by increasing breathlessness.

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10009033
E.1.2	Term	Chronic obstructive pulmonary disease
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine the effects of PUL-042 Inhalation Solution on peak lower respiratory symptom score (as measured by Mallia et al [see clinical protocol]) in GOLD stage 0 COPD subjects with an experimentally introduced rhinovirus infection with laboratory human rhinovirus strain HRV A16. All subjects will be negative for serum neutralizing antibody to HRV A16 at screening prior to viral inoculation.

E.2.2

Secondary objectives of the trial

The effect of PUL-042 on upper respiratory symptoms:
• As measured by the Jackson score as measured by Mallia et al and the Wisconsin Upper Respiratory Symptom Survey-11 (WURSS-11).

The effect of PUL-042 on lower respiratory symptoms:
• As measured by Mallia et al, the Exacerbations of Chronic obstructive pulmonary disease Tool-Respiratory Symptoms (EXACT-RS) score and the COPD Assessment Test (CAT) score.

The effect of PUL-042 on clinic-measured lung function tests:
• PEF, FEV1, FVC and FEV1/FVC ratio.

The effect of PUL-042 on the number of successfully infected patients, as determined by detectable virus load, or sero-conversion at day 42.

The safety and tolerability of PUL-042 Inhalation Solution in ) in GOLD stage 0 COPD subjects with an experimentally introduced rhinovirus infection with laboratory human rhinovirus strain HRV A16.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects will be eligible for entry into the study if they fulfil all of the following inclusion criteria:
1. Male or female subjects, aged 18-75 years inclusive, with symptoms (cough, sputum production) suggestive of GOLD stage 0 COPD for at least one year prior to the screening visit in accordance with the GOLD 2014 guidelines;
2. Current smokers with ≥10 pyh;
3. Subject has risk of COPD defined by GOLD Staging Criteria level 0 where the subjects’ post-bronchodilator FEV1/FVC ratio ≥0.70 and FEV1 is ≥80% normal predicted;
4. CAT score at screening ≥3 and less than or equal to 15;
5. Sero-negativity to HRV A16 neutralizing antibody;
6. Patients together with their partners of reproduction potential (males and females) must practice an acceptable method of birth control with a failure rate of a Pearl index of less than 1% per year, to be used consistently and correctly throughout the course of the study. Acceptable methods of birth control in this study include: combined (oestrogen and progestogen containing) hormonal contraception associated with the inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, placement of an intrauterine device, placement of an intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner (provided that the partner is the sole sexual partner of a female trial participant [if they are a woman of child bearing potential] and that the vasectomised partner has received medical assessment of the surgical success), or true sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject). Periodic abstinence (calendar, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. These contraceptive methods must be used during study participation.
Additional pregnancy testing will be performed for female subjects who consent to take part in the study, from the Baseline Visit up to and including the final Follow-up Visit. If any pregnancy test indicates that an active study participant is pregnant, the patient will be withdrawn in accordance with Section 11.2 of the protocol and all necessary follow up completed (as per Section 12.4 of the protocol).
A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
7. Ability to understand and give informed consent.

E.4

Principal exclusion criteria

1. Sero-positivity to HRV A16;
2. Use of systemic or nasal topical steroids, inhaled corticosteroids (ICS), systemic immunosuppressants, antibiotics, LABA, and LAMA and oral theophylline and/or roflumilast within 30 days before study day -1;
3. Subjects with evidence of an upper or lower respiratory infection within 6 weeks prior to study day -8;
4. A history or current evidence of bronchiectasis, cystic fibrosis, interstitial lung disease or other significant chronic lung disease;
5. A history within the last 5 years or current evidence of carcinoma of the bronchus;
6. A history within the last 5 years or current evidence of asthma;
7. A history of active tuberculosis or history of significant lung disease as a result of previous tuberculosis infection;
8. A medical history or current clinical evidence of significant hematological, gastrointestinal, renal, hepatic, cerebrovascular, immunologic, psychiatric or cardiovascular disease or event (including uncontrolled hypertension as determined by the Investigator), or any clinical condition that may, in the opinion of the Investigator or Medical Monitor, impact on the subject’s ability to participate in the study;
9. Clinical laboratory values at screening for neutrophils, hemoglobin and hematocrit which reflect grade 2 or higher reductions from normal range, or ALT results which reflect grade 2 or higher elevations per the ‘CTCAE’ guidelines Subjects with other clinical laboratory abnormalities outside normal reference ranges will be considered for inclusion, if in the opinion of the Principal Investigator or Medical Monitor the abnormalities are not clinically significant, or will not jeopardize the safety of the subject or the validity of the study;
10. Use of cold preparations, anti-cholinergics, nasal lavage preparations or sprays, cough medications, or prescription or over-the-counter nasal decongestants within 30 days before study day -8;
11. Current (at screening and/or on any day from screening to study day -1) abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding 2 years;
12. A positive pregnancy test at baseline;
13. Received an investigational drug or vaccine within 30 days or 5 half-lives (whichever is longer), or use of an investigational medical device within 30 days prior to the screening visit or in the interval between screening and study day -1;
14. Inability to tolerate nebulization based on the Principal Investigator’s medical judgment or a ≥12% drop in FEV1 at study day -8, at either 15 or 30 minutes after the completion of administration of a dose of nebulization test solution (SWFI) of the same volume and under the same nebulization conditions that is planned to be used for study drug administration, compared to the FEV1 obtained immediately prior to administration of the nebulization test solution.

E.5 End points

E.5.1

Primary end point(s)

To determine the effects of PUL-042 Inhalation Solution on peak lower respiratory symptom score (as measured by Mallia et al [see clinical protocol]) in GOLD stage 0 COPD subjects with an experimentally-introduced rhinovirus infection with laboratory human rhinovirus strain HRV A16.

E.5.1.1

Timepoint(s) of evaluation of this end point

DAYS:
-1 (predose, 15 min, 30 min, 1, 2, 4,6 and 8 hours post-dose);
0;
1;
2 (predose, 15 min, 30 min, 1, 2, 4,6 and 8 hours post-dose);
3-7 inclusive;
9, 12, 15 21 +/- 1 day;
42 +/-2 days.

E.5.2

Secondary end point(s)

The effect of PUL-042 on upper respiratory symptoms:
• As measured by the Jackson score as measured by Mallia et al and the Wisconsin Upper Respiratory Symptom Survey-11 (WURSS-11),

The effect of PUL-042 on lower respiratory symptoms:
• As measured by Mallia et al, the EXAcerbations of Chronic obstructive pulmonary disease Tool-Respiratory Symptoms (EXACT-RS) score and the COPD Assessment Test (CAT) score.

The effect of PUL-042 on clinic-measured lung function tests:
• PEF, FEV1, FVC and FEV1/FVC ratio.

The effect of PUL-042 on inflammatory mediators (nasal, sputum and serum) outcomes during the ~ 6 weeks post dosing.

The effect of PUL-042 on the number of successfully infected patients, as determined by detectable virus load, or sero-conversion at day 42.

The safety and tolerability of PUL-042 Inhalation Solution in ) in GOLD stage 0 COPD subjects with an experimentally introduced rhinovirus infection with laboratory human rhinovirus strain HRV A16.

E.5.2.1

Timepoint(s) of evaluation of this end point

DAYS:
-1 (predose, 15 min, 30 min, 1, 2, 4,6 and 8 hours post-dose);
0;
1;
2 (predose, 15 min, 30 min, 1, 2, 4,6 and 8 hours post-dose);
3-7 inclusive;
9, 12, 15 21 +/- 1 day;
42 +/-2 days.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Visit 16 (Study Day 42 ± 2 days)
The following assessments will be conducted:
• HRV 16A serum neutralizing antibody assessment
• Complete physical examination
• Oximetry
• Spirometry
• Hematology and biochemistry samples
• Serum sample for inflammatory mediators
• Nasal lavage and nasosorption
• URT & WURSS-11 assessment
• LRT, CAT, and EXACT-RS assessment
• Review patient completed materials in clinic
• AE assessment
• Concomitant medication assessment
• eCRF completion

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-11-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-12-14

P. End of Trial
P.	End of Trial Status	GB - no longer in EU/EEA

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