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A Study to Assess the Efficacy, Safety, and Tolerability of CAT-354 in Subjects With Asthma

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
CAT-354 1 mg/kg
CAT-354 5 mg/kg
CAT-354 10 mg/kg
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, CAT-354, Tralokinumab

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed and dated written informed consent is obtained prior to any study related procedure taking place
  • Women either infertile (example [e.g.], hysterectomized, sterile or post-menopausal with amenorrhea of least 1 year duration) or who are practicing an acceptable form of birth control
  • Uncontrolled (refractory) asthma despite treatment with a minimum dose of 800 microgram (mcg) beclomethasonedipropionate or equivalent inhaled corticosteroid per day plus 1 or more additional controller, that is, long-acting beta-agonist, leukotriene antagonist or theophylline. Oral corticosteroids (not parenteral) as additional treatment at any dose are acceptable
  • A forced expiratory volume in 1 second (FEV1) acceptable for airway hyper-responsiveness (AHR) challenge tests (greater than 60 percent of predicted normal) on the challenge days
  • A provocative concentration of methacholine causing a 20 percent fall in FEV1 (PC20) less than 4 milligram per milliliter (mg/mL)
  • Aged 18-80 years
  • A 12-lead electrocardiogram (ECG) with no-clinically significant abnormalities
  • Clinical chemistry, hematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator
  • Body weight of less than 130 kilogram (kg)
  • No other clinically significant abnormality on history and clinical examination
  • Able to comply with the requirements of the protocol.

Exclusion Criteria:

  • Experienced a severe exacerbation within 28 days preceding Day -28/-14 to Day 0
  • Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Day -28/-14 to Day 0
  • Subjects with a history of allergic rhinitis, seasonal allergy or esophagitis must be optimally controlled and remain on a stable treatment regimen during the study
  • Participation in another study within 5 half-lives or 3 months of the start of this study, whichever is the longer
  • Lower respiratory tract infection within 6 weeks of Day -28/-14 to Day 0
  • Current smokers or ex-smokers with greater than 10 pack-years
  • Blood donation (more than 550 mL) in the previous 2 months
  • Excessive intake of alcohol (as judged by the Investigator) or evidence of drug or solvent abuse
  • Subjects with a physician-diagnosis of any other significant lung disease, including a primary diagnosis of chronic obstructive pulmonary disease or bronchiectasis, or lung cancer, sarcoidosis, tuberculosis, pulmonary fibrosis and cystic fibrosis
  • Concurrent medication from Day -28/-14 to Day 0 (Screening visit) and for the duration of the study with any of the prohibited medications
  • Significant, uncontrolled disease including serious psychological disorders, chronic renal failure, uncontrolled hypertension
  • systolic blood pressure greater than 200 millimeters of mercury (mmHg), or diastolic blood pressure greater than 100 mmHg, heart disease, psoriasis requiring treatment and subjects who have had a heart attack or stroke within the 3 months preceding Day -28/-14 to Day 0, or who have a known aneurysm
  • Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Day -28/-14 to Day 0
  • Subjects with a history of allergic rhinitis, seasonal allergy or esophagitis must be optimally controlled and remain on a stable treatment regimen during the study
  • Any factor which, in the opinion of the Investigator, would jeopardize the evaluation or safety or be associated with poor adherence to the protocol (that is, inability to complete study diary, perform peak expiratory flow (PEF) measurements)
  • The subject's primary care physician recommends the subject should not take part in the study
  • Known hypersensitivity to CAT-354 or its components, to the challenge agents used in the study or to related drugs.

Sites / Locations

  • St. Vincents Hospital, Thoracic Medicine Unit
  • Respiratory Medicine Department, Mater Adult Hospital,
  • Princess Alexandria Hospital, Dept of Respiratory Medicine
  • Eastern Clinical Research Unit
  • Monash Medical Centre, Dept Respiratory Medicine.
  • Dep of Respiratory & Sleep Medicine, Western Hospital
  • Respiratory & Sleep Medicine, Royal Melbourne Hospital
  • Lung Institute WA, Sir Charles Gardner Hospital
  • WA Lung Research, Sir Charles Gairdner Hospital
  • Evangelische Lungenklinik Berlin - Kardiologie/Pneumologie - 1.OG, Haus 23
  • Med. Klinik m. S. Infektiologie und Pneumologie, Charite - Universitätsmedizin Berlin
  • Lungen und Bronchialheikunde
  • Praxis für Lungen-und Bronchialheilkunde, Allergologie und Umweltmedizin
  • Rheinische Friedrich-Wilhelms-Universität, Medizinische Klinik und Poliklinik II, Innere Medizin
  • Internistisches Facharztzentrum Stresemannallee
  • Universitätsklinikum Magdeburg Fachbereich Pneumologie
  • Universitätsklinikum Mainz, Klinische Forschung Pneumologie, III. med. Klinik
  • Universitätsklinikum Münster Klinik und Poliklinik für Dermatologie
  • Universität Rostock, Medizinische Fakultät Klinik und Poliklinik für Innere Medizin
  • Johanniter-Krankenhaus im Fläming gGmbH, Pneumologie
  • Academisch Medisch Centrum
  • Prywatny Gabinet Internistyczno-Alergologiczny
  • ISPL Centrum Medyczne
  • Samodzielny Publiczny Centralny Szpital Kliniczny Slaskiej Akademii Medycznej, Klinika Pneumologii
  • Niepubliczny Zakład Opieki Zdrowotnej Atopia
  • Szpital ZOZ Lubin Oddzial Alergologiczny i Chorob Wewnetrznych
  • Wojewodzki Szpital Specjalistyczny, Poradnia Alergologiczna
  • Alergopneuma Przychodnia Alergologiczno-Pulmonologiczna Marek Michnar i wsp.
  • Instytut Gruzlicy i Chorob Pluc
  • Wojewódzki Szpital Specjalistyczny w Zgierzu
  • Uniwersytecki Szpital Kliniczny nr 1 Im. Norberta Barlickiego w Łodzi
  • Belfast City Hospital
  • Birmingham Heartlands Hospital
  • Gartnavel General Hospital
  • University Hospitals of Leicester NHS Trust, Glenfield Hospital
  • Royal Brompton Hospital
  • University Hospital of South Manchester NHS Foundation Trust
  • Royal Victoria Infirmary
  • Royal Gwent Hospital
  • Norfolk and Norwich University Hospital
  • Lister Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

CAT-354 1 mg/kg

CAT-354 5 mg/kg

CAT-354 10 mg/kg

Arm Description

Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.

CAT-354 1 milligram per kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56

Outcomes

Primary Outcome Measures

Change From Baseline in Doubling Concentration of Methacholine at Day 28
Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized for sub-therapeutic dose (placebo and CAT-354 1 milligram/kilogram [mg/kg]) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.

Secondary Outcome Measures

Change From Baseline in Doubling Concentration of Methacholine at Day 56, 84 or Early Termination
Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Forced Expiratory Volume in 1 Second (FEV1)
The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Forced Vital Capacity (FVC)
The FVC was volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
Percentage of FEV1 was calculated as (FEV1/FVC)*100. It signified the percentage of the total amount of air exhaled from the lungs during the first second of forced exhalation. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Result was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Asthma Control Questionnaire (ACQ) Total Score
The ACQ is questionnaire that comprises of 7-questions evaluating participant's asthma control. Six self-administered questions assess asthma control over the past week covering nocturnal waking, morning symptoms, activity limitations, shortness of breath, wheezing, and short-acting bronchodilator use; using 7-point ordinal rating scale from 0 (good control) to 6 (poor control). Seventh question is completed by a health professional on forced expiratory volume in 1 second (FEV1) percentage (%) predicted; scale: 0 (greater than [>] 95% predicted) to 6 (less than [<] 50% predicted. Final score is the average score of the 7 questions, with a score range of 0 (well controlled) to 6 (extremely poor controlled). Result was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
Number of Participants With Diary Data
Participants recorded asthma symptoms, use of reliever inhalers (beta-agonist use for symptom relief and as prophylaxis), and morning and evening peak expiratory flow (PEF) measurements in a diary.
Number of Participants With Exacerbations
Exacerbation was defined as: Mild (determined from diary data) - 2 consecutive days satisfying the same or 1 of the following criteria: any night with awakening(s) due to asthma or morning PEF 20 % or more below baseline where baseline = average of the 10 days before randomization or as-needed medication use of 2 inhalations or more in 24 hours above baseline where baseline = average of the 10 days before randomization. Severe (determined by taking an exacerbation update and history): deterioration of asthma resulting in emergency treatment or hospitalization or need for oral steroids for 3 days or more (as judged by the Investigator).
Morning Peak Flow and Peak Flow Variability
Peak flow is a participant's maximum speed of expiration.
Adult Asthma Quality of Life (QoL) Questionnaire Final Score
The AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants are asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. The 4 domain scores are the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment).
Maximum Observed Serum Concentration (Cmax) for CAT-354
Minimum Observed Serum Concentration (Cmin) for CAT-354
Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0 - t]) for CAT-354
Accumulation Ratio for CAT-354 (RA)
Accumulation ratio (RA) is calculated for Cmax, Cmin and AUC as RA for Cmax = Cmax (56 - 84)/Cmax (0 - 28); Similarily, RA for Cmin = Cmin (56 - 84)/Cmin (0 - 28) and RA for AUC= AUC (56 - 84)/AUC (0 - 28) where Cmax (0 - 28) and Cmax (56 - 84) are the maximum observed serum concentration after first dose (Day 0 to Day 28) and after third dose (Day 56 to Day 84), respectively; Cmin (0 - 28) and Cmin (56 - 84) are the minimum observed serum concentration after first and third dose, respectively; AUC (0 - 28) and AUC (56 - 84) are the area under the serum concentration time curve over a dosage interval determined after first and third dose, respectively.
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pre-treatment state.

Full Information

First Posted
March 13, 2008
Last Updated
December 7, 2016
Sponsor
MedImmune LLC
Collaborators
Cambridge Antibody Technology, PRA Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00640016
Brief Title
A Study to Assess the Efficacy, Safety, and Tolerability of CAT-354 in Subjects With Asthma
Official Title
A Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of CAT-354
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated prematurely by the sponsor due to slow recruitment.
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedImmune LLC
Collaborators
Cambridge Antibody Technology, PRA Health Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To investigate the effects of CAT-354 on airway hyper-responsiveness (AHR) in uncontrolled asthma.
Detailed Description
This is a randomized, stratified, double-blind, placebo-controlled, multicenter, multinational study in subjects with uncontrolled asthma despite optimal treatment. Following confirmation of eligibility, subjects will be randomly assigned on Day 0, to 1 of 4 dose groups 1 mg/kg CAT-354, 5 mg/kg CAT-354, 10 mg/kg CAT or Placebo to match all doses of CAT-354. Doses of the assigned treatment will be administered on three occasions 28 days apart. Subjects will be assessed for efficacy, including airway hyper-responsiveness (AHR), safety, pharmacokinetic, pharmacodynamics and immunogenicity until Day 84 post-first dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, CAT-354, Tralokinumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
Arm Title
CAT-354 1 mg/kg
Arm Type
Experimental
Arm Description
CAT-354 1 milligram per kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Arm Title
CAT-354 5 mg/kg
Arm Type
Experimental
Arm Description
CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Arm Title
CAT-354 10 mg/kg
Arm Type
Experimental
Arm Description
CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Tralokinumab
Intervention Description
Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
Intervention Type
Biological
Intervention Name(s)
CAT-354 1 mg/kg
Other Intervention Name(s)
Tralokinumab
Intervention Description
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Intervention Type
Biological
Intervention Name(s)
CAT-354 5 mg/kg
Other Intervention Name(s)
Tralokinumab
Intervention Description
CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Intervention Type
Other
Intervention Name(s)
CAT-354 10 mg/kg
Intervention Description
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Primary Outcome Measure Information:
Title
Change From Baseline in Doubling Concentration of Methacholine at Day 28
Description
Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized for sub-therapeutic dose (placebo and CAT-354 1 milligram/kilogram [mg/kg]) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Time Frame
Baseline and Day 28
Secondary Outcome Measure Information:
Title
Change From Baseline in Doubling Concentration of Methacholine at Day 56, 84 or Early Termination
Description
Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Time Frame
Baseline, Day 56, 84 or early termination (any time before Day 84)
Title
Forced Expiratory Volume in 1 Second (FEV1)
Description
The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Time Frame
Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, 63, 84 or early termination (any time before Day 84)
Title
Forced Vital Capacity (FVC)
Description
The FVC was volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Time Frame
Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, 63, 84 or early termination (any time before Day 84)
Title
Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
Description
Percentage of FEV1 was calculated as (FEV1/FVC)*100. It signified the percentage of the total amount of air exhaled from the lungs during the first second of forced exhalation. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Result was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Time Frame
Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, Day 63, 84 or early termination (any time before Day 84)
Title
Asthma Control Questionnaire (ACQ) Total Score
Description
The ACQ is questionnaire that comprises of 7-questions evaluating participant's asthma control. Six self-administered questions assess asthma control over the past week covering nocturnal waking, morning symptoms, activity limitations, shortness of breath, wheezing, and short-acting bronchodilator use; using 7-point ordinal rating scale from 0 (good control) to 6 (poor control). Seventh question is completed by a health professional on forced expiratory volume in 1 second (FEV1) percentage (%) predicted; scale: 0 (greater than [>] 95% predicted) to 6 (less than [<] 50% predicted. Final score is the average score of the 7 questions, with a score range of 0 (well controlled) to 6 (extremely poor controlled). Result was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Time Frame
Baseline, Day 28, 56, 84 or early termination (any time before Day 84)
Title
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Description
The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
Time Frame
Day 0 to 84
Title
Number of Participants With Diary Data
Description
Participants recorded asthma symptoms, use of reliever inhalers (beta-agonist use for symptom relief and as prophylaxis), and morning and evening peak expiratory flow (PEF) measurements in a diary.
Time Frame
Day 0, 4, 14, 28, 35, 56, 63 to Day and 84
Title
Number of Participants With Exacerbations
Description
Exacerbation was defined as: Mild (determined from diary data) - 2 consecutive days satisfying the same or 1 of the following criteria: any night with awakening(s) due to asthma or morning PEF 20 % or more below baseline where baseline = average of the 10 days before randomization or as-needed medication use of 2 inhalations or more in 24 hours above baseline where baseline = average of the 10 days before randomization. Severe (determined by taking an exacerbation update and history): deterioration of asthma resulting in emergency treatment or hospitalization or need for oral steroids for 3 days or more (as judged by the Investigator).
Time Frame
Day 0 to Day 84
Title
Morning Peak Flow and Peak Flow Variability
Description
Peak flow is a participant's maximum speed of expiration.
Time Frame
Day 0 to Day 84
Title
Adult Asthma Quality of Life (QoL) Questionnaire Final Score
Description
The AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants are asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. The 4 domain scores are the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment).
Time Frame
Day 0, 28, 84 or early termination (any time before Day 84)
Title
Maximum Observed Serum Concentration (Cmax) for CAT-354
Time Frame
Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
Title
Minimum Observed Serum Concentration (Cmin) for CAT-354
Time Frame
Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
Title
Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0 - t]) for CAT-354
Time Frame
Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
Title
Accumulation Ratio for CAT-354 (RA)
Description
Accumulation ratio (RA) is calculated for Cmax, Cmin and AUC as RA for Cmax = Cmax (56 - 84)/Cmax (0 - 28); Similarily, RA for Cmin = Cmin (56 - 84)/Cmin (0 - 28) and RA for AUC= AUC (56 - 84)/AUC (0 - 28) where Cmax (0 - 28) and Cmax (56 - 84) are the maximum observed serum concentration after first dose (Day 0 to Day 28) and after third dose (Day 56 to Day 84), respectively; Cmin (0 - 28) and Cmin (56 - 84) are the minimum observed serum concentration after first and third dose, respectively; AUC (0 - 28) and AUC (56 - 84) are the area under the serum concentration time curve over a dosage interval determined after first and third dose, respectively.
Time Frame
Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
Title
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Description
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame
Day 0 to 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed and dated written informed consent is obtained prior to any study related procedure taking place Women either infertile (example [e.g.], hysterectomized, sterile or post-menopausal with amenorrhea of least 1 year duration) or who are practicing an acceptable form of birth control Uncontrolled (refractory) asthma despite treatment with a minimum dose of 800 microgram (mcg) beclomethasonedipropionate or equivalent inhaled corticosteroid per day plus 1 or more additional controller, that is, long-acting beta-agonist, leukotriene antagonist or theophylline. Oral corticosteroids (not parenteral) as additional treatment at any dose are acceptable A forced expiratory volume in 1 second (FEV1) acceptable for airway hyper-responsiveness (AHR) challenge tests (greater than 60 percent of predicted normal) on the challenge days A provocative concentration of methacholine causing a 20 percent fall in FEV1 (PC20) less than 4 milligram per milliliter (mg/mL) Aged 18-80 years A 12-lead electrocardiogram (ECG) with no-clinically significant abnormalities Clinical chemistry, hematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator Body weight of less than 130 kilogram (kg) No other clinically significant abnormality on history and clinical examination Able to comply with the requirements of the protocol. Exclusion Criteria: Experienced a severe exacerbation within 28 days preceding Day -28/-14 to Day 0 Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Day -28/-14 to Day 0 Subjects with a history of allergic rhinitis, seasonal allergy or esophagitis must be optimally controlled and remain on a stable treatment regimen during the study Participation in another study within 5 half-lives or 3 months of the start of this study, whichever is the longer Lower respiratory tract infection within 6 weeks of Day -28/-14 to Day 0 Current smokers or ex-smokers with greater than 10 pack-years Blood donation (more than 550 mL) in the previous 2 months Excessive intake of alcohol (as judged by the Investigator) or evidence of drug or solvent abuse Subjects with a physician-diagnosis of any other significant lung disease, including a primary diagnosis of chronic obstructive pulmonary disease or bronchiectasis, or lung cancer, sarcoidosis, tuberculosis, pulmonary fibrosis and cystic fibrosis Concurrent medication from Day -28/-14 to Day 0 (Screening visit) and for the duration of the study with any of the prohibited medications Significant, uncontrolled disease including serious psychological disorders, chronic renal failure, uncontrolled hypertension systolic blood pressure greater than 200 millimeters of mercury (mmHg), or diastolic blood pressure greater than 100 mmHg, heart disease, psoriasis requiring treatment and subjects who have had a heart attack or stroke within the 3 months preceding Day -28/-14 to Day 0, or who have a known aneurysm Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Day -28/-14 to Day 0 Subjects with a history of allergic rhinitis, seasonal allergy or esophagitis must be optimally controlled and remain on a stable treatment regimen during the study Any factor which, in the opinion of the Investigator, would jeopardize the evaluation or safety or be associated with poor adherence to the protocol (that is, inability to complete study diary, perform peak expiratory flow (PEF) measurements) The subject's primary care physician recommends the subject should not take part in the study Known hypersensitivity to CAT-354 or its components, to the challenge agents used in the study or to related drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Mayer, M.D.
Organizational Affiliation
PRA Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
St. Vincents Hospital, Thoracic Medicine Unit
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Respiratory Medicine Department, Mater Adult Hospital,
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Princess Alexandria Hospital, Dept of Respiratory Medicine
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Eastern Clinical Research Unit
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Monash Medical Centre, Dept Respiratory Medicine.
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Dep of Respiratory & Sleep Medicine, Western Hospital
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Respiratory & Sleep Medicine, Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Lung Institute WA, Sir Charles Gardner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
WA Lung Research, Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Evangelische Lungenklinik Berlin - Kardiologie/Pneumologie - 1.OG, Haus 23
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Med. Klinik m. S. Infektiologie und Pneumologie, Charite - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
D-13353
Country
Germany
Facility Name
Lungen und Bronchialheikunde
City
Bonn
ZIP/Postal Code
53123
Country
Germany
Facility Name
Praxis für Lungen-und Bronchialheilkunde, Allergologie und Umweltmedizin
City
Bonn
ZIP/Postal Code
53123
Country
Germany
Facility Name
Rheinische Friedrich-Wilhelms-Universität, Medizinische Klinik und Poliklinik II, Innere Medizin
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Internistisches Facharztzentrum Stresemannallee
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Universitätsklinikum Magdeburg Fachbereich Pneumologie
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Universitätsklinikum Mainz, Klinische Forschung Pneumologie, III. med. Klinik
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum Münster Klinik und Poliklinik für Dermatologie
City
Munster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universität Rostock, Medizinische Fakultät Klinik und Poliklinik für Innere Medizin
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Johanniter-Krankenhaus im Fläming gGmbH, Pneumologie
City
Treuenbrietzen
ZIP/Postal Code
14929
Country
Germany
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Prywatny Gabinet Internistyczno-Alergologiczny
City
Bialystok
ZIP/Postal Code
15-025
Country
Poland
Facility Name
ISPL Centrum Medyczne
City
Białystok
ZIP/Postal Code
15-003
Country
Poland
Facility Name
Samodzielny Publiczny Centralny Szpital Kliniczny Slaskiej Akademii Medycznej, Klinika Pneumologii
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Niepubliczny Zakład Opieki Zdrowotnej Atopia
City
Kraków
ZIP/Postal Code
31-159
Country
Poland
Facility Name
Szpital ZOZ Lubin Oddzial Alergologiczny i Chorob Wewnetrznych
City
Lubin
ZIP/Postal Code
59-300
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny, Poradnia Alergologiczna
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Alergopneuma Przychodnia Alergologiczno-Pulmonologiczna Marek Michnar i wsp.
City
Lublin
ZIP/Postal Code
20-607
Country
Poland
Facility Name
Instytut Gruzlicy i Chorob Pluc
City
Warszawa
ZIP/Postal Code
01-138
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny w Zgierzu
City
Zgierz
ZIP/Postal Code
95-100
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny nr 1 Im. Norberta Barlickiego w Łodzi
City
Łódź
ZIP/Postal Code
91-153
Country
Poland
Facility Name
Belfast City Hospital
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Gartnavel General Hospital
City
Glasgow
ZIP/Postal Code
G12 OYN
Country
United Kingdom
Facility Name
University Hospitals of Leicester NHS Trust, Glenfield Hospital
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6HP
Country
United Kingdom
Facility Name
University Hospital of South Manchester NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Royal Gwent Hospital
City
Newport
ZIP/Postal Code
NP20 2UB
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Lister Hospital
City
Stevenage, Hertfordshire
ZIP/Postal Code
SG1 4AB
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study to Assess the Efficacy, Safety, and Tolerability of CAT-354 in Subjects With Asthma

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