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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00640016




Registration number
NCT00640016
Ethics application status
Date submitted
13/03/2008
Date registered
20/03/2008
Date last updated
31/01/2017

Titles & IDs
Public title
A Study to Assess the Efficacy, Safety, and Tolerability of CAT-354 in Subjects With Asthma
Scientific title
A Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of CAT-354
Secondary ID [1] 0 0
2007-002090-31
Secondary ID [2] 0 0
CAT-354-0603
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Placebo
Treatment: Other - CAT-354 1 mg/kg
Treatment: Other - CAT-354 5 mg/kg
Other interventions - CAT-354 10 mg/kg

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

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

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

Experimental: CAT-354 10 mg/kg - CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56


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

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

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

Other interventions: CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Doubling Concentration of Methacholine at Day 28
Timepoint [1] 0 0
Baseline and Day 28
Secondary outcome [1] 0 0
Change From Baseline in Doubling Concentration of Methacholine at Day 56, 84 or Early Termination
Timepoint [1] 0 0
Baseline, Day 56, 84 or early termination (any time before Day 84)
Secondary outcome [2] 0 0
Forced Expiratory Volume in 1 Second (FEV1)
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
Forced Vital Capacity (FVC)
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
Timepoint [4] 0 0
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)
Secondary outcome [5] 0 0
Asthma Control Questionnaire (ACQ) Total Score
Timepoint [5] 0 0
Baseline, Day 28, 56, 84 or early termination (any time before Day 84)
Secondary outcome [6] 0 0
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Timepoint [6] 0 0
Day 0 to 84
Secondary outcome [7] 0 0
Number of Participants With Diary Data
Timepoint [7] 0 0
Day 0, 4, 14, 28, 35, 56, 63 to Day and 84
Secondary outcome [8] 0 0
Number of Participants With Exacerbations
Timepoint [8] 0 0
Day 0 to Day 84
Secondary outcome [9] 0 0
Morning Peak Flow and Peak Flow Variability
Timepoint [9] 0 0
Day 0 to Day 84
Secondary outcome [10] 0 0
Adult Asthma Quality of Life (QoL) Questionnaire Final Score
Timepoint [10] 0 0
Day 0, 28, 84 or early termination (any time before Day 84)
Secondary outcome [11] 0 0
Maximum Observed Serum Concentration (Cmax) for CAT-354
Timepoint [11] 0 0
Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
Secondary outcome [12] 0 0
Minimum Observed Serum Concentration (Cmin) for CAT-354
Timepoint [12] 0 0
Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
Secondary outcome [13] 0 0
Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0 - t]) for CAT-354
Timepoint [13] 0 0
Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
Secondary outcome [14] 0 0
Accumulation Ratio for CAT-354 (RA)
Timepoint [14] 0 0
Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
Secondary outcome [15] 0 0
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Timepoint [15] 0 0
Day 0 to 84

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2008
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
St. Vincents Hospital, Thoracic Medicine Unit - Darlinghurst
Recruitment hospital [2] 0 0
Respiratory Medicine Department, Mater Adult Hospital, - South Brisbane
Recruitment hospital [3] 0 0
Princess Alexandria Hospital, Dept of Respiratory Medicine - Woolloongabba
Recruitment hospital [4] 0 0
Eastern Clinical Research Unit - Box Hill
Recruitment hospital [5] 0 0
Monash Medical Centre, Dept Respiratory Medicine. - Clayton
Recruitment hospital [6] 0 0
Dep of Respiratory & Sleep Medicine, Western Hospital - Footscray
Recruitment hospital [7] 0 0
Respiratory & Sleep Medicine, Royal Melbourne Hospital - Parkville
Recruitment hospital [8] 0 0
Lung Institute WA, Sir Charles Gardner Hospital - Nedlands
Recruitment hospital [9] 0 0
WA Lung Research, Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3011 - Footscray
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Berlin
Country [2] 0 0
Germany
State/province [2] 0 0
Bonn
Country [3] 0 0
Germany
State/province [3] 0 0
Frankfurt
Country [4] 0 0
Germany
State/province [4] 0 0
Magdeburg
Country [5] 0 0
Germany
State/province [5] 0 0
Mainz
Country [6] 0 0
Germany
State/province [6] 0 0
Munster
Country [7] 0 0
Germany
State/province [7] 0 0
Rostock
Country [8] 0 0
Germany
State/province [8] 0 0
Treuenbrietzen
Country [9] 0 0
Netherlands
State/province [9] 0 0
Amsterdam
Country [10] 0 0
Poland
State/province [10] 0 0
Bialystok
Country [11] 0 0
Poland
State/province [11] 0 0
Katowice
Country [12] 0 0
Poland
State/province [12] 0 0
Kraków
Country [13] 0 0
Poland
State/province [13] 0 0
Lubin
Country [14] 0 0
Poland
State/province [14] 0 0
Lublin
Country [15] 0 0
Poland
State/province [15] 0 0
Warszawa
Country [16] 0 0
Poland
State/province [16] 0 0
Zgierz
Country [17] 0 0
Poland
State/province [17] 0 0
Lódz
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Belfast
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Birmingham
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Glasgow
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Leicester
Country [22] 0 0
United Kingdom
State/province [22] 0 0
London
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Manchester
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Newcastle upon Tyne
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Newport
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Norwich
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Stevenage, Hertfordshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MedImmune LLC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cambridge Antibody Technology
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
PRA Health Sciences
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Mayer, M.D.
Address 0 0
PRA Health Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00640016