Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QAX576 in Asthma Patients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00940160
First received: July 14, 2009
Last updated: January 20, 2010
Last verified: January 2010
  Purpose

This study is designed to investigate the safety and tolerability of multiple doses of QAX576 in controlled or partially controlled asthma patients.


Condition Intervention Phase
Asthma
Drug: QAX576
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled, Study To Compare The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Doses Of Intravenous Administration Of QAX576 In Controlled Or Partially Controlled Asthma Patients

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: Assessing and comparing the safety and tolerability of multiple doses of QAX576 in controlled and partially controlled asthma patients. [ Time Frame: 120 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessing the pharmacokinetics of multiple doses of QAX576 in asthmatics [ Time Frame: 120 Days ] [ Designated as safety issue: No ]
  • Assessing the effect of QAX576 on asthma control using assessments such as exhaled NO, FEV1 variability data captures by PIKO-1 home monitoring device and the extent of inhaled salbutamol use as rescue medication. [ Time Frame: 120 Days ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: July 2009
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: QAX576 1 mg/kg Drug: QAX576
Active Comparator: QAX576 3 mg/kg Drug: QAX576
Active Comparator: QAX576 10 mg/kg Drug: QAX576
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-smoking male and female subjects age 18 to 65 years, inclusive; with controlled or partially controlled asthma who are otherwise healthy as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. Female subjects are allowed to participate in this study if they are postmenopausal or surgically sterilized.
  • Controlled or partially controlled asthma as defined in GINA 2007.
  • At Screening, and Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed after the subject has rested for at least three (3) minutes.
  • Female subjects must be post-menopausal as confirmed by FSH ≥ 40, or have been surgically sterilized at least 6 months prior to screening.
  • Subjects must have a body mass index (BMI) within the range of 18 to 30 kg/m2.
  • Male subjects must be using two methods of contraception, i.e., spermicidal gel plus condom, for the entire duration of the study, up to Study Completion visit, and refrain from fathering a child in the six (6) months after study completion

Exclusion criteria

  • Smokers (use of tobacco products in the previous 3 months).
  • Use of any prescription drugs other than stable (4 weeks) use of hormone replacement or thyroid replacement within four (4) weeks prior to dosing (other than medication required for treatment of asthma).
  • Use of any over the counter (OTC) medication within forty eight (48) hours prior to dosing.
  • Use of oral steroids within 12 weeks prior to dosing.
  • Patients who have received an investigational drug in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
  • Any immunotherapy with systemic biologics as a treatment therapy or during a clinical study with in the last 6 months.
  • Any immunotherapy with subcutaneous injections for allergy (allergy shots), within 3 months.
  • Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
  • Patients suffering from hay fever at screening or likely to require treatment during the study.
  • History of chronic respiratory disease other than asthma or chronic allergic rhinitis.
  • Hospitalization for asthma in the last year.
  • History of intubation/assisted ventilation for asthma in the last 5 years.
  • History of autonomic dysfunction (e.g. history of fainting, orthostatic hypotension).
  • History or presence of any surgical or medical condition or clinically significant abnormal laboratory findings, which, in the opinion of the investigator, may jeopardize the subject in case of participation in the study.
  • History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
  • History of clinical schistosomiasis or travel within the preceding 6 months to an area with endemic schistosomiasis, including but not limited to Southeast Asia and Northwest Africa.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00940160

Locations
Russian Federation
Novartis Investigator Site
Moscow, Russian Federation
Novartis Investigator Site
St. Petersburg, Russian Federation
United Kingdom
Novartis Investigator Site
Manchester, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00940160     History of Changes
Other Study ID Numbers: CQAX576A2107
Study First Received: July 14, 2009
Last Updated: January 20, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Novartis:
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014