Two-part pharmacokinetic and pharmacodynamic study of LAS190792 in patients with asthma and COPD

Exclusion Criteria

• (PART 1 and 2):
• - Subjects who do not conform to the above inclusion criteria
• - Current smokers, subjects with a smoking history during the last 12 months or subjects with a smoking history of more than 10 pack-years
• - Other relevant pulmonary disease or history of thoracic surgery
• - Subjects with a BMI ≥40 kg/m2 (only applicable for Part 2)
• - Subjects with any clinically relevant history or presence of abnormality from the medical history and/or physical examination (only applicable for Part 1)
• - Current evidence or recent history of any clinically significant and unstable disease (other than COPD) or abnormality that could put the subject at risk or could confound the results of the study (only applicable for Part 2)
• - Subjects with a surgical history clinically relevant for the purpose of the study
• - History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localised basal cell carcinoma of the skin
• - Subjects with serious adverse reaction or serious hypersensitivity to Spiriva (for Part 2 only), indacaterol (for Part 2 only), or the formulation excipients (eg, lactose) or other drugs in the same pharmacologic class (for Part 1 and Part 2)
• - Current diagnosis of COPD (for Part 1 only) or history of / or current diagnosis for asthma (for Part 2 only)
• - Recent history of asthma / COPD exacerbation requiring hospitalisation or need for increased maintenance treatments for asthma / COPD within 6 weeks prior to screening or randomisation
• - Use of daily oxygen therapy >10 h per day (for Part 2 only)
• - Use of systemic steroids for respiratory reasons within 3 months prior to screening
• - Lower respiratory tract infection within 6 weeks prior to screening or randomisation
• - Upper respiratory tract infection requiring antibiotics within 4 weeks prior to screening or randomisation
• - Current history of tuberculosis, bronchiectasis or other non-specific pulmonary disease
• - QTcF interval >430 ms at screening or prior to randomisation, or history of long QT syndrome (for Part 1 only)
• - QTcF interval, >450 ms for males and >470 ms for females at screening or prior to randomisation, or history of long QT syndrome (for Part 2 only)
• - Subjects with a history of excessive use or abuse of alcohol or with a history of drug abuse within the past 2 years
• - Subjects who are positive for drugs of abuse and alcohol tests at screening and prior to randomisation
• - Donation or loss >400 ml of blood and plasma within the previous 3 months prior to screening
• - Subjects consuming more than 14 (female subjects) or 21 (male subjects) units of alcohol a week
• - Subjects with a significant infection or known inflammatory process at screening or prior to randomisation
• - Subjects with acute gastrointestinal symptoms at the time of screening or prior to randomisation
• - Subjects with an acute infection such as influenza at the time of screening or prior to randomisation
• - Male subjects who do not agree to follow instructions to avoid pregnancies
• - Subjects who are not able to adhere to the restrictions on prior and concomitant medications
• - Subjects who intend to use any concomitant medication not permitted by the protocol or who have not undergone the required washout period for a particular prohibited medication
• - Subjects who have used any investigational drug within 3 months prior to screening or within the equivalent time of 6 half-lives of receiving the last administration, whichever is longer
• - Subjects who have received the last dose of investigational product more than 3 months ago but who are on an extended follow-up
• - Subjects who are vegans or who have medical dietary restrictions
• - Subjects unable to communicate reliably with the Investigator
• - Subjects who are unlikely to co-operate with the requirements of the study