Single Dose Study to Assess Efficacy and Safety of 4 Doses of LAS100977 in Chronic Obstructive Pulmonary Disease (COPD) Population
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: LAS100977; LAS100977; LAS100977; LAS100977; Reference; Placebo
Intervention description: Dry powder inhalation,Once daily, single dose; Dry powder inhalation,Once daily, single dose; Dry powder inhalation,Once daily, single dose; Dry powder inhalation,Once daily, single dose; Dry powder inhalation (capsule),single dose; Dry powder inhalation or Dry powder inhalation (capsule),Once daily, single dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The purpose of this study is to evaluate the pharmacodynamics (bronchodilation) of single
      doses of inhaled LAS100977 in COPD patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and non-pregnant, non-lactating females aged 40 or older.

          2. Patients with a clinical diagnosis of COPD, according to the GOLD guidelines and
             stable airway obstruction.

          3. Patients with a post-salbutamol FEV1 equal to or greater than 30% of the predicted
             value and less than 80% of the predicted value

          4. Post-salbutamol FEV1/FVC < 70% at screening visit.

          5. Pre-dose FEV1 value of first treatment period within the range of 80-120% of the FEV1
             measured at screening prior to salbutamol inhalation.

          6. Current, or ex-cigarette smokers (former) with a smoking history of at least 10
             pack-years.

          7. Patients whose COPD symptoms at the time of randomisation are stable compared to the
             Screening visit, according to the investigator's medical judgment.

        Exclusion Criteria:

          1. History or current diagnosis of asthma.

          2. A respiratory tract infection or COPD exacerbation in the six weeks prior to the
             screening visit.

          3. Patients who have been hospitalised for an acute COPD exacerbation in the 3 months
             prior to screening visit.

          4. Clinically significant respiratory conditions other than COPD condition.

          5. Clinically significant cardiovascular conditions.

          6. Patients unable to properly use a dry powder or pMDI inhaler device or unable to
             perform acceptable spirometry.

          7. Clinically relevant abnormalities laboratory, ECG parameters or physical examination
             results at the screening evaluation that in the investigator's opinion, preclude study
             participation.

          8. Patients who intend to use any concomitant medication not permitted by this protocol
             or who have not undergone the required washout period for a particular prohibited
             medication.