Safety of Exercise and High-dose Salbutamol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Receiving Therapeutic Doses of Indacaterol (QAB 149) and Salmeterol
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis
Age
40–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients between 40 and 75 years of age diagnosed with chronic obstructive pulmonary disease (COPD). Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception.
Body mass index (BMI) must be within the range of 18 to 32.
You may not be if
Participation in any clinical investigation with experimental drug therapy within four weeks prior to dosing or longer as required by local regulation.
Donation or loss of 400 mL or more of blood within two months prior to dosing.
Significant illness (other than respiratory) within two weeks prior to dosing.
A past medical history of, or a family history (grandparents, parents and siblings) of a prolonged QT-interval syndrome or a prolonged QT-interval at screening.
Any clinically significant medical abnormalities (excluding COPD) limiting ability to perform standardized exercise protocol on cycle ergometer will exclude the patient. For example, arthritis.
History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis).
A known hypersensitivity to the study drug or drugs similar to the study drug.
History of immunocompromise, including a positive HIV, Hepatitis B or C test result.
History of drug or alcohol abuse within the 12 months prior to dosing
Any conditions that in the opinion of the investigator may compromise patient safety, interfere with evaluations, or preclude the completion of the trial.
Clareo Health | Safety of Exercise and High-dose Salbutamol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Receiving Therapeutic Doses of Indacaterol (QAB 149) and Salmeterol
