78 week double-blind, placebo-controlled, parallel-group trial to determine the effect of Xolair on airway inflammation and remodeling
Involves a subcutaneous Xolair injection every 2 weeks or 4 weeks (based on weight & blood IgE levels) and bronchoscopy procedures at Visit 3 (week 0) and Visit 8 (week 78).
Inclusion Criteria:
- 18-60 years
- Body weight below 150 kg
- Moderate-severe allergic asthma on high dose Inhaled Corticosteroids (>800mcg/day) and LABA (Long Acting Beta-Agonist) for at least 3 months prior to screen
- Non-smokers or former smokers with less than 10 pack year history
Exclusion Criteria:
- Cannot be taking beta blockers, immunosuppressants, maintenance steroids, leukotriene receptor antagonists, theophylline, or oral/inhaled anti-cholinergics
- Cannot have taken Xolair previously
- Cannot have an exacerbation or respiratory infection in 4 weeks prior to screen
- Cannot have clotting disorder or history of intubation for asthma
- Cannot have taken investigational drug within 30 days of screen
Compensation:
$100 for full screen ($25 for paperwork only, $50 for paperwork and Spirometry only)
$100 for each injection visit.
$700 for each Bronchoscopy visit
14 week, Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of MEDI-563 and the effects of MEDI-563 on airway eosinophil counts.
Single dose IV infusion (for first 12 patients enrolled; possibility of multiple doses after 12 patients enrolled and data analysis)
Bronchoscopy at screen (after passing all other screening procedures), day 28 and (optional) at end of study.
Inclusion Criteria:
- 18-65 years
- Previously documented history of asthma of at least 1 yr duration
- No changes in asthma meds in 4 wks prior to screening visit
Exclusion Criteria:
- Cannot have any asthma related hospitalizations in last year
- Cannot use any inhaled or oral immunosuppressive drugs (Inhaled Corticosteroids allowed)
- Cannot be using a beta blocker
- History of drug/alcohol abuse within 1 year
- History of cancer other than basal/squamous cell/in-situ cervical ca (must have been treated at least 1 yr ago)
- History of Tuberculosis or Positive PPD without effective treatment
- History of HIV, Hepatitis or Clotting disorder
- Cannot have used tobacco products within 2 years of baseline visit or have smoking history of greater than 10 pack years
Compensation:
$800 for full screen (including Bronchoscopy) ($25 for paperwork only; $50 paperwork and Spirometry; $100 for all procedures except Bronchoscopy)
$100 for each visit to ABI with infusion/labs, etc
$700 for each Bronchoscopy
Natural History Mechanisms of Airways Disease through Molecular Analysis of Airway Secretions. (Airways Disease Sputum Protocol = ADSP)
The purpose of this study is to investigate mechanisms causing acute asthma and COPD exacerbations by examining blood and airway secretions (spontaneous sputum sample) during an acute onset. The subjects will be followed up for induced sputum samples at 30 and 60 days post flair. This pilot study is intended to uncover new mechanisms of airways exacerbations for future study at the laboratories of the Airways Biology Initiative (ABI).
Involves 3 study visits. The first is as an inpatient for the acute flair where a spontaneous sputum sample will be obtained and blood taken for DNA and RNA. The following 2 visits will require induced sputum and blood samples.
Inclusion Criteria:
Subject is an adult male or female between 18 and 75 years of age inclusive.
Subject must have a pre-history of a physician’s diagnosis of asthma, COPD, or non-Cystic Fibrosis bronchiectasis, with exclusion of other significant pulmonary diseases (ie cystic fibrosis, tuberculosis, Interstitial Lung Disease and bronchopulmonary dysplasia).
Subject is currently experiencing an acute exacerbation of their airways disease.
The subject may be a smoker or non-smoker.
The subject must be capable of and willing to provide written informed consent
The subject is able to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions.
Exclusion Criteria:
As a result of the medical interview, physical examination or screening investigations, the physician responsible considers the volunteer unfit for the study.
The subject has received an investigational drug or participated in any other research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer), prior to the current study.
The subject has a history of alcohol or drug abuse within the last 5 years.
The subject has history of hepatitis B, hepatitis C, or HIV virus.
The subject has a pneumonia or sepsis
The subject is pregnant or lactating.
Compensation:
$50 for each study visit for a total of $150 for completion of the entire study.
PENN REGISTRY FOR AIRWAYS DISEASE RESEARCH (RADR) PROTOCOL
A registry for Asthma, COPD and Healthy smoking and non-smoking subjects. Involves a single visit with a blood draw, urine specimen and questionnaire.
Inclusion Criteria:
1) Age ≥ 18 years old
2) Diagnosis of asthma or COPD, confirmed by a pulmonologist or allergist in keeping with the definitions above
3) Healthy control subjects presenting to the clinical research unit of the ABI.
4) Able and willing to sign an informed consent form
Compensation:
$25 for study visit.
Future Studies that will be conducted
