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Clinical Trial Results:
A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter, International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients with Emphysema

Summary
EudraCT number	2008-005326-36
Trial protocol	GB NL SE DK DE IE
Global end of trial date	11 Dec 2013

Results information
Results version number	v1(current)
This version publication date	05 Sep 2019
First version publication date	05 Sep 2019
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

Kamada-AAT(inhaled)-007

ISRCTN number

-

US NCT number

NCT01217671

WHO universal trial number (UTN)

-

Sponsor organisation name

Kamada Ltd

Sponsor organisation address

2 Holtzman Street, Weizmann Science Park, Rehovot, Israel, 7670402

Public contact

Sponsor, Kamada Limited, 00972 89406472,

Scientific contact

Sponsor, Kamada Limited, 00972 89406472,

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

26 Feb 2016

Is this the analysis of the primary completion data?

Yes

Primary completion date

10 Dec 2013

Global end of trial reached?

Yes

Global end of trial date

11 Dec 2013

Was the trial ended prematurely?

No

Main objective of the trial

To explore rate and severity of exacerbations in AAT deficient patients when treated with inhaled AAT or placebo during a 50-week double-blind treatment period. The objective will be evaluated by the primary endpoint of the time from randomization to the first exacerbation with a severity of moderate or severe.

Protection of trial subjects

Patients were trained in the operation and cleaning of the eFlow® inhalation device (PARI Pharma GmbH, Germany). Instructions included a demonstration of the nebuliser and training in the use of an electronic diary (eDiary, the LogPad (PHT Corporation, Switzerland)). This diary recorded the daily condition of the patient so that the physicians could be alerted if there was a change in the clinical condition of the patient and respond accordingly.

Background therapy

Study patients were allowed free use of concomitant medications for the treatment of the underlying disease, including antibiotics, steroids (inhaled and systemic), as well as any additional therapy approved by the principal investigator of the study site

Evidence for comparator

-

Actual start date of recruitment

18 Mar 2010

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

1 Years

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Netherlands: 36

Country: Number of subjects enrolled

Sweden: 22

Country: Number of subjects enrolled

United Kingdom: 56

Country: Number of subjects enrolled

Denmark: 13

Country: Number of subjects enrolled

Germany: 14

Country: Number of subjects enrolled

Ireland: 15

Country: Number of subjects enrolled

Canada: 12

Worldwide total number of subjects

168

EEA total number of subjects

156

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

135

From 65 to 84 years

33

85 years and over

0

Subject disposition

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Recruitment details

Men and women over the age of 18 with a diagnosis of emphysema confirmed by computed tomography (CT) scan and a record of inherited severe AATD (ZZ or other rare genotypes with a serum AAT level below 11 µM). Patients (168) were recruited between 18/March/2010 and 17/December/2012 in 12 sites in 7 countries. Randomization was 1:1 placebo or AAT.

Screening details

The inclusion criteria included FEV1 percent predicted post-bronchodilator < 80%, and a history of two or more moderate or severe exacerbations requiring a change in treatment (antibiotics, systemic steroids, hospitalization) over the past 18 months, with at least one episode within the 12 months prior to screening.

Period 1 title

Overall Trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Blinding implementation details

Eligible patients were randomized 1:1 to receive study drug or placebo by an IVRS system. Allocation of the study drug during the study was also regulated by the IVRS. Site staff telephoned IVRS prior to dispensing the study drug and were notified of the AAT kit labels to be dispensed.

Are arms mutually exclusive

Yes

Kamada-AAT for Inhalation

Arm description

Study Drug was administered by eFlow® nebulizer twice daily, each session lasting for approximately 10 to 15 minutes. If the subject was required to inhale a bronchodilator, this was administered prior to inhalation of the placebo. Kamada-AAT for Inhalation was supplied in sterile, single-use glass vials containing 4 mL of a ready-to-use solution.

Arm type

Experimental

Investigational medicinal product name

Kamada AAT for Inhalation

Investigational medicinal product code

EMEA/H/C/003934

Other name

Pharmaceutical forms

Inhalation solution

Routes of administration

Inhalation use

Dosage and administration details

Treatment with study drug began at the baseline/randomization visit and continued for a period of 50 weeks. During this period, either Kamada-AAT for Inhalation 80 mg or placebo was administered by eFlow® nebulizer twice daily, each session lasting for approximately 10 to 15 minutes (i.e., a total daily dose of 160 mg of AAT or an equivalent volume of placebo). If the subject was required to inhale a bronchodilator, this was administered prior to inhalation of study drug.

Placebo for Inhalation

Arm description

Placebo was administered by eFlow® twice daily, each session lasting for approximately 10 to 15 minutes. If the subject was required to inhale a bronchodilator, this was administered prior to inhalation of the placebo. The placebo was supplied in sterile, single-use glass vials containing 4 mL of a ready-to-use solution.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

EMEA/H/C/003934

Other name

Kamada-AAT for Inhalation

Pharmaceutical forms

Inhalation solution

Routes of administration

Inhalation use

Dosage and administration details

Treatment with study drug began at the baseline/randomization visit and continued for a period of 50 weeks. During this period, either Kamada-AAT for Inhalation 80 mg or placebo was administered by eFlow® twice daily, each session lasting for approximately 10 to 15 minutes (i.e., a total daily dose of 160 mg of AAT or an equivalent volume of placebo). If the subject was required to inhale a bronchodilator, this was administered prior to inhalation of the AAT.

Number of subjects in period 1	Kamada-AAT for Inhalation	Placebo for Inhalation
Started	85	83
Completed	51	69
Not completed	34	14
Adverse event, serious fatal	1	-
Possible side effects	1	-
No confirmed AATD	-	1
Consent withdrawn by subject	12	4
Health and social circumstances	1	-
Adverse event, non-fatal	15	6
Patient moved to lung transplantation list	1	-
Family Circumstances	-	1
Lost to follow-up	2	2
Failure to attend visits	1	-

Baseline characteristics

Top of page

Reporting group title

Kamada-AAT for Inhalation

Reporting group description

Study Drug was administered by eFlow® nebulizer twice daily, each session lasting for approximately 10 to 15 minutes. If the subject was required to inhale a bronchodilator, this was administered prior to inhalation of the placebo. Kamada-AAT for Inhalation was supplied in sterile, single-use glass vials containing 4 mL of a ready-to-use solution.

Reporting group title

Placebo for Inhalation

Reporting group description

Placebo was administered by eFlow® twice daily, each session lasting for approximately 10 to 15 minutes. If the subject was required to inhale a bronchodilator, this was administered prior to inhalation of the placebo. The placebo was supplied in sterile, single-use glass vials containing 4 mL of a ready-to-use solution.

Reporting group values	Kamada-AAT for Inhalation	Placebo for Inhalation	Total
Number of subjects	85	83	168
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	67	68	135
From 65-84 years	18	15	33
85 years and over	0	0	0
Age continuous
Units: years
median (inter-quartile range (Q1-Q3))	57 (48 to 63)	53 (46.5 to 61.5)	-
Gender categorical
Units: Subjects
Female	34	34	68
Male	51	49	100

End points

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Reporting group title

Kamada-AAT for Inhalation

Reporting group description

Study Drug was administered by eFlow® nebulizer twice daily, each session lasting for approximately 10 to 15 minutes. If the subject was required to inhale a bronchodilator, this was administered prior to inhalation of the placebo. Kamada-AAT for Inhalation was supplied in sterile, single-use glass vials containing 4 mL of a ready-to-use solution.

Reporting group title

Placebo for Inhalation

Reporting group description

Placebo was administered by eFlow® twice daily, each session lasting for approximately 10 to 15 minutes. If the subject was required to inhale a bronchodilator, this was administered prior to inhalation of the placebo. The placebo was supplied in sterile, single-use glass vials containing 4 mL of a ready-to-use solution.

Primary: The time from randomization to the first event-based exacerbation with a severity of moderate or severe

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End point title

The time from randomization to the first event-based exacerbation with a severity of moderate or severe

End point description

A moderate event-based exacerbation was defined as a course of treatment with antibiotics and/or systemic corticosteroids and severe exacerbation as an episode requiring hospitalisation. For patients taking routine antibiotics, any increase in the current dose of antibiotics or change of type of antibiotics was deemed to indicate a moderate exacerbation. The time to first moderate/severe and mild/moderate/severe exacerbation was derived from the subject’s eDiary and updated after a blind review by two experts in the field. They reconciled the eDiary data with the concomitant medications and reports of treatment emergent adverse events in order to determine the start date and severity of the symptom-based exacerbation.

End point type

Primary

End point timeframe

50 weeks

End point values	Kamada-AAT for Inhalation	Placebo for Inhalation
Number of subjects analysed	63	60
Units: Days	112	140

Time to first serious or moderate exacerbation

Statistical analysis description

Median days to first serious or moderate exacerbation

Comparison groups

Kamada-AAT for Inhalation v Placebo for Inhalation

Number of subjects included in analysis

123

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

= 0.0952 ^[2]

Method

Logrank

Confidence interval

Notes
[1] - Analysis of ITT population
[2] - p Value from Log Rank comparison between treatments adjusted for country

Post-hoc: Improvement in lung function measures

Top of page

End point title

Improvement in lung function measures

End point description

Overall change of FEV1 from baseline to 50 weeks

End point type

Post-hoc

End point timeframe

Change from baseline to 50 weeks

End point values	Kamada-AAT for Inhalation	Placebo for Inhalation
Number of subjects analysed	85 ^[3]	83 ^[4]
Units: ml
number (not applicable)	18.6	-29.4

Attachments

Untitled (Filename: Overall Change in FEV1.pdf)

Notes
[3] - The parameter is calculated as the overall change so all the patients contribute to the final value
[4] - The parameter is calculated as the overall change so all the patients contribute to the final value

Change in FEV1

Statistical analysis description

Overall change of FEV1 from baseline to 50 weeks

Comparison groups

Kamada-AAT for Inhalation v Placebo for Inhalation

Number of subjects included in analysis

168

Analysis specification

Post-hoc

Analysis type

superiority ^[5]

P-value

= 0.0124 ^[6]

Method

Mixed models analysis

Parameter type

LS Mean overall change from baseline

Point estimate

48

Confidence interval

level

95%

sides

2-sided

lower limit

13.5

upper limit

82.43

Variability estimate

Standard error of the mean

Notes
[5] - The results along the DB period were analyzed by Mixed Model For Repeated Measures (MMRM) comparing the least squares means for the changes from baseline at week 50 and the overall effect in the two cohorts
[6] - The same pattern of statistical significant favourable response in the AAT-treated patients group was observed, regardless of the imputation method used to deal with missing data.

Adverse events

Top of page

Timeframe for reporting adverse events

54 weeks

Adverse event reporting additional description

50 weeks of treatment and 4 weeks follow-up. Events were reported by the patient

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

12.1

Reporting group title

Safety Population AAT

Reporting group description

All patients who were exposed to study drug

Reporting group title

Safety Population Placebo

Reporting group description

All patients who were not exposed to study drug

Serious adverse events	Safety Population AAT	Safety Population Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	30 / 87 (34.48%)	15 / 81 (18.52%)
number of deaths (all causes)	1	0
number of deaths resulting from adverse events	1	0
Investigations
Electrocardiogram T wave inversion
subjects affected / exposed	1 / 87 (1.15%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
subjects affected / exposed	1 / 87 (1.15%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine leiomyosarcoma
subjects affected / exposed	1 / 87 (1.15%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Multiple fractures
subjects affected / exposed	1 / 87 (1.15%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle strain
subjects affected / exposed	1 / 87 (1.15%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Arterial haemorrhage
subjects affected / exposed	1 / 87 (1.15%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cardiac disorders
Angina pectoris
subjects affected / exposed	1 / 87 (1.15%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Facial palsy
subjects affected / exposed	1 / 87 (1.15%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Idiopathic thrombocytopenia purpura
subjects affected / exposed	1 / 87 (1.15%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	0 / 87 (0.00%)	1 / 81 (1.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Food poisoning
subjects affected / exposed	1 / 87 (1.15%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
subjects affected / exposed	4 / 87 (4.60%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	1 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	7 / 87 (8.05%)	6 / 81 (7.41%)
occurrences causally related to treatment / all	1 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Emphysema
subjects affected / exposed	1 / 87 (1.15%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoptysis
subjects affected / exposed	1 / 87 (1.15%)	1 / 81 (1.23%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	1 / 87 (1.15%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Paranasal cyst
subjects affected / exposed	0 / 87 (0.00%)	1 / 81 (1.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleuritic pain
subjects affected / exposed	1 / 87 (1.15%)	1 / 81 (1.23%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Bronchiectasis
subjects affected / exposed	1 / 87 (1.15%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	2 / 87 (2.30%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infective exacerbation of chronic obstructive airways disease
subjects affected / exposed	1 / 87 (1.15%)	1 / 81 (1.23%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	4 / 87 (4.60%)	2 / 81 (2.47%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Lung infection
subjects affected / exposed	1 / 87 (1.15%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis
subjects affected / exposed	0 / 87 (0.00%)	1 / 81 (1.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	4 / 87 (4.60%)	3 / 81 (3.70%)
occurrences causally related to treatment / all	1 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	1 / 87 (1.15%)	1 / 81 (1.23%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sputum purulent
subjects affected / exposed	1 / 87 (1.15%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 3%

Non-serious adverse events	Safety Population AAT	Safety Population Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	86 / 87 (98.85%)	78 / 81 (96.30%)
Nervous system disorders
Headache
subjects affected / exposed	9 / 87 (10.34%)	10 / 81 (12.35%)
occurrences all number	12	13
General disorders and administration site conditions
Fatigue
subjects affected / exposed	9 / 87 (10.34%)	9 / 81 (11.11%)
occurrences all number	16	10
Influenza like illness
subjects affected / exposed	8 / 87 (9.20%)	7 / 81 (8.64%)
occurrences all number	21	16
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	8 / 87 (9.20%)	10 / 81 (12.35%)
occurrences all number	10	12
Dry mouth
subjects affected / exposed	7 / 87 (8.05%)	4 / 81 (4.94%)
occurrences all number	7	5
Nausea
subjects affected / exposed	10 / 87 (11.49%)	5 / 81 (6.17%)
occurrences all number	14	6
Vomiting
subjects affected / exposed	4 / 87 (4.60%)	5 / 81 (6.17%)
occurrences all number	4	5
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
subjects affected / exposed	41 / 87 (47.13%)	38 / 81 (46.91%)
occurrences all number	92	84
Cough
subjects affected / exposed	17 / 87 (19.54%)	16 / 81 (19.75%)
occurrences all number	24	20
Dysphonia
subjects affected / exposed	5 / 87 (5.75%)	7 / 81 (8.64%)
occurrences all number	5	8
Dyspnoea
subjects affected / exposed	37 / 87 (42.53%)	33 / 81 (40.74%)
occurrences all number	70	69
Haemoptysis
subjects affected / exposed	5 / 87 (5.75%)	2 / 81 (2.47%)
occurrences all number	7	2
Nasal congestion
subjects affected / exposed	1 / 87 (1.15%)	5 / 81 (6.17%)
occurrences all number	1	7
Oropharyngeal pain
subjects affected / exposed	10 / 87 (11.49%)	5 / 81 (6.17%)
occurrences all number	13	7
Productive cough
subjects affected / exposed	14 / 87 (16.09%)	8 / 81 (9.88%)
occurrences all number	21	13
Sputum discoloured
subjects affected / exposed	9 / 87 (10.34%)	2 / 81 (2.47%)
occurrences all number	11	2
Sputum increased
subjects affected / exposed	7 / 87 (8.05%)	4 / 81 (4.94%)
occurrences all number	9	8
Wheezing
subjects affected / exposed	2 / 87 (2.30%)	6 / 81 (7.41%)
occurrences all number	2	6
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
subjects affected / exposed	5 / 87 (5.75%)	6 / 81 (7.41%)
occurrences all number	8	6
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
subjects affected / exposed	7 / 87 (8.05%)	3 / 81 (3.70%)
occurrences all number	13	13
Influenza
subjects affected / exposed	6 / 87 (6.90%)	2 / 81 (2.47%)
occurrences all number	9	5
Lower respiratory tract infection
subjects affected / exposed	17 / 87 (19.54%)	14 / 81 (17.28%)
occurrences all number	44	29
Nasopharyngitis
subjects affected / exposed	12 / 87 (13.79%)	12 / 81 (14.81%)
occurrences all number	17	14
Oral candidiasis
subjects affected / exposed	7 / 87 (8.05%)	1 / 81 (1.23%)
occurrences all number	9	1
Rhinitis
subjects affected / exposed	5 / 87 (5.75%)	3 / 81 (3.70%)
occurrences all number	7	4
Sinusitis
subjects affected / exposed	8 / 87 (9.20%)	2 / 81 (2.47%)
occurrences all number	8	3
Upper respiratory tract infection
subjects affected / exposed	8 / 87 (9.20%)	9 / 81 (11.11%)
occurrences all number	12	13

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

While the study did not meet the primary endpoint of time to first moderate or severe exacerbation, post hoc analysis showed that treatment with Kamada- AAT for Inhalation improved pulmonary function

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The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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