2 visit study (screening and Bronchoscopy ) + follow up phone call to obtain lung tissue from healthy and COPD subjects for biomarker identification.
Inclusion Criteria:
- 40-70 years
- Body weight > 50 kg (110 lbs) for men and > 45 kg (99 lbs) for women; BMI between 19.0-30.0 kg/m2
- Current smoker with at least 10 pack years or former (no tobacco within 3 months prior to screen) smoker with at least 10 pack years
Exclusion Criteria:
- No significant disease other than COPD (Hepatitis, HIV)
- No contraindications to Bronchoscopy
- Cannot have taken any investigational medications within 30 days or 5 half-lives (whichever is longer) of screening
- Cannot have taken part in a Bronchoscopy study in the last 4 months
- Cannot have history of alcohol/drug abuse in the last 5 years
- Cannot have Respiratory Infection within 4 weeks of screen
- Cannot have personal/family history of clotting or platelet disorder
- Cannot be taking anticoagulants or Aspirin > 81 mg/day
- Cannot be on Macrolide antibiotics or oral corticosteroids within 2 weeks of screen (exacerbation)
- Cannot be on oxygen therapy
Compensation:
$100 for full screen ($25 paperwork only; $50 paperwork and Spirometry)
$700 for Bronchoscopy
7 week Phase 2A, double-blind, placebo-controlled, multi-center, dose-escalation study to evaluate the safety and efficacy of BIO-11006 inhalation in subjects with COPD (mucus inhibitor for subjects with chronic bronchitis)
Inclusion Criteria:
- Age 45 or older
- Active COPD with chronic bronchitis (must have chronic productive cough for 3 months in the last 2 years with no other cause for cough OR sputum production at least several days/week for last 4 weeks)
- Current or previous smoker with at least a 20 pack year history
Exclusion Criteria:
- Cannot have treatment with oral Prednisone in 6 weeks prior to enrollment
- Cannot have change in asthma treatment dose in 6 weeks prior to enrollment
- Cannot have treatment with Oxygen in 6 weeks prior to enrollment
- Cannot have a change in smoking history in 6 months prior to enrollment
- Cannot have clinically significant heart, liver, lung disease (other than COPD), history of malignancy (except basal cell ca)
- Cannot have chest infection in 6 weeks prior to enrollment
- Cannot have unstable Hypertension or Diabetes (as evidenced by a medical change in 3 monthss prior to screen)
- Cannot be enrolled in another drug study within 30 days prior to enrollment in this study
Compensation ($650 total):
$50 for full screen
$100 for Baseline, and $100 (each) for Day 21, 28, and 49 visits.
$50 for all other Visits
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
