A Trial to Assess the Safety, Tolerability and Pharmacokinetics of MDT-637 in Subjects With Inter… (NCT01556607) | Clinical Trial Compass
CompletedPhase 1
A Trial to Assess the Safety, Tolerability and Pharmacokinetics of MDT-637 in Subjects With Intermittent, or Mild-to-Moderate Persistent, Asthma
United States10 participantsStarted 2012-03
Plain-language summary
The purpose of this study is to assess the safety and tolerability of MDT-637, when inhaled by subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Documented clinical history and physician diagnosis of intermittent or mild or moderate persistent asthma for at least 6 months prior to screening OR subjects with historical record of Beta-agonist reversibility within previous 5 years
✓. Subjects must demonstrate bronchial hyper-reactivity on methacholine challenge of PC20 less than 8mg/mL.
✓. Visit 2 FEV1 (with no treatment change in the interim) must be within 12% of Visit 1 result
✓. Males and/or females (if not surgically sterile or confirmed to be post menopausal) must agree to practice 2 barrier contraception methods until they are discharged from the study
✓. Willing to give written informed consent
✓. 18 to 50 years of age
✓. BMI of 19-30 kg/m2
✓. Non-smoker (for at least 90 days prior to screening) and willing to abstain from smoking during the course of the study
Exclusion criteria
✕. Uncontrolled, clinically significant disease which in the opinion of the Principal Investigator, Medical Monitor or Sponsor (MicroDose Therapeutx; MDTx) would place the subject at risk through study participation or would confound the assessment of the safety of MDT-637
✕. Inability to perform acceptable and repeatable spirometry in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
✕. Abnormal FEV1, FVC, or FEV1/FVC (FEV1 and FVC \< 75% of predicted and/or FEV1/FVC ratio \< 0.7)
What they're measuring
1
Safety and Tolerability of escalating doses of MDT-637 when inhaled by subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma.
Timeframe: Up to 61 days (including up to 42 days of screening period)
✕. FEV1 variability \> 12% between Visit 1 and Visit 2
✕. Evidence of current or history of additional respiratory disease (other than asthma); for instance emphysema, chronic bronchitis or cystic fibrosis.
✕. Upper respiratory tract infection within 6 weeks of Visit 1
✕. Use of rescue albuterol or other short acting bronchodilator (SAB) more often than five times per week
✕. History of significant nasal irritation from nasal inhalation of medication