Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
1. Healthy male subjects
Item
1. Healthy male subjects
boolean
C1708335 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
2. Aged between 18 - 50 years
Item
2. Aged between 18 - 50 years
boolean
C0001779 (UMLS CUI [1])
3. Non-smokers (never smoked or not smoking >6 month with <10 pack years history)
Item
3. Non-smokers (never smoked or not smoking >6 month with <10 pack years history)
boolean
C0337672 (UMLS CUI [1])
C1519384 (UMLS CUI [2,1])
C1277691 (UMLS CUI [2,2])
4. Normal spirometry (FEV1 >=80% of predicted, FEV1/FVC >= 70%)
Item
4. Normal spirometry (FEV1 >=80% of predicted, FEV1/FVC >= 70%)
boolean
C0037981 (UMLS CUI [1])
C0429706 (UMLS CUI [2])
C0730560 (UMLS CUI [3])
5. A signed and dated written informed consent is obtained from the subject
Item
5. A signed and dated written informed consent is obtained from the subject
text
C0021430 (UMLS CUI [1])
6. The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Item
6. The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
boolean
C0021430 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
7. Available to complete the study.
Item
7. Available to complete the study.
boolean
C0470187 (UMLS CUI [1,1])
C2348577 (UMLS CUI [1,2])
8. Body mass index within the range 18.0 to 34.9 kg/m2
Item
8. Body mass index within the range 18.0 to 34.9 kg/m2
boolean
C1305855 (UMLS CUI [1])
9. Response to Ipratropium bromide defined as
Item
9. Response to Ipratropium bromide defined as an increase in sGaw of >= 25% over pre-dose baseline at 2 h following 80ug ipratropium bromide; or a documented increase in sGaw of >= 25% over pre-dose baseline at 2h following of 80ug of ipratropium bromide within 3 month of screening
boolean
C0700580 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
C0442805 (UMLS CUI [2])
C0439565 (UMLS CUI [3,1])
C1442488 (UMLS CUI [3,2])
1. Any clinically relevant abnormality identified at the screening medical assessment (physical examination/ medical history), clinical laboratory tests, or ECG (12-Lead or Holter)
Item
1. Any clinically relevant abnormality identified at the screening medical assessment (physical examination/ medical history), clinical laboratory tests, or ECG (12-Lead or Holter)
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
C0022885 (UMLS CUI [4])
C1623258 (UMLS CUI [5])
C0013801 (UMLS CUI [6])
2. A history of breathing problems (i.e. history of asthmatic symptomatology). Screening lung function tests (FEV1, FVC and sGaw) will be performed to confirm normal lung function parameters.
Item
2. A history of breathing problems (i.e. history of asthmatic symptomatology). Screening lung function tests (FEV1, FVC and sGaw) will be performed to confirm normal lung function parameters.
boolean
C0262926 (UMLS CUI [1,1])
C0035203 (UMLS CUI [1,2])
C1254481 (UMLS CUI [1,3])
C0004096 (UMLS CUI [2])
C0024119 (UMLS CUI [3])
C0748133 (UMLS CUI [4])
C1287681 (UMLS CUI [5])
3. QTC interval | Electrocardiography | Electrocardiogram: P-R interval | QT interval - finding | EKG: T wave abnormal
Item
3. A mean QTc(D) value at screening >430msec. the QTc(D) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 120 - 210 msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave)
boolean
C0489625 (UMLS CUI [1])
C1623258 (UMLS CUI [2])
C0429087 (UMLS CUI [3])
C1287082 (UMLS CUI [4])
C0438167 (UMLS CUI [5])
4. A history of elevated supine blood pressure or a mean blood pressure equal to or higher than 160/95 mmHg at screening
Item
4. A history of elevated supine blood pressure or a mean blood pressure equal to or higher than 160/95 mmHg at screening
boolean
C0005823 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
5. A mean heart rate outside the range 40 - 90 bpm at screening.
Item
5. A mean heart rate outside the range 40 - 90 bpm at screening.
boolean
C0018810 (UMLS CUI [1])
6. History of use of tobacco or nicotine containing products within 6 months of screening, or positive urine cotinine at screening.
Item
6. History of use of tobacco or nicotine containing products within 6 months of screening, or positive urine cotinine at screening.
boolean
C0841002 (UMLS CUI [1])
C0439861 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0028040 (UMLS CUI [2,3])
C1697737 (UMLS CUI [3,1])
C1446409 (UMLS CUI [3,2])
7. The subject has donated a unit of blood within a month prior to the first dosing occasion or intends to donate within a month of the end of the study
Item
7. The subject has donated a unit of blood within a month prior to the first dosing occasion or intends to donate within a month of the end of the study
boolean
C0005794 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C0205435 (UMLS CUI [2,2])
C0444496 (UMLS CUI [3])
8. The subject is currently taking regular (or course of) medication, whether prescribed or not, including vitamins and herbal remedies such as St. John's Wort.
Item
8. The subject is currently taking regular (or course of) medication, whether prescribed or not, including vitamins and herbal remedies such as St. John's Wort.
boolean
C0013227 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0278329 (UMLS CUI [2])
C0042890 (UMLS CUI [3])
C0025125 (UMLS CUI [4])
C0813171 (UMLS CUI [5])
9. Take prescription medications | Before; Dosage | Drugs, Non-Prescription | Safety Issue | Affecting; research results
Item
9. The subject has taken: prescription medications within the past 2 weeks prior to dosing, or OTC medications within 48 hours prior to dosing, unless it is judged by the Investigator not to comprimise their safety or influence the outcome of the study
boolean
C3843193 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0013231 (UMLS CUI [3])
C2911688 (UMLS CUI [4])
C0392760 (UMLS CUI [5,1])
C0683954 (UMLS CUI [5,2])
10. The subject has participated in a study with a new molecular entity or any other trial within a period of 3-months prior to dosing
Item
10. The subject has participated in a study with a new molecular entity or any other trial within a period of 3-months prior to dosing
boolean
C2348568 (UMLS CUI [1])
11. The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV (if tested according to site GOP's)
Item
11. The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV (if tested according to site GOP's)
boolean
C0281863 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0019682 (UMLS CUI [3])
12. The subject has a positive drugs-of-abuse test
Item
12. The subject has a positive drugs-of-abuse test
boolean
C0373483 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
13. The subjet has a positive alcohol urine test, including ethanol
Item
13. The subjet has a positive alcohol urine test, including ethanol
boolean
C2188602 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
14. The subject has a suspected history of alcohol abuse within the six months previous to the screening visit.
Item
14. The subject has a suspected history of alcohol abuse within the six months previous to the screening visit.
boolean
C0085762 (UMLS CUI [1])
15. The subject is unable to use the DISKUS™ and HandiHaler devices correctly
Item
15. The subject is unable to use the DISKUS™ and HandiHaler devices correctly
boolean
C1524063 (UMLS CUI [1,1])
C0021461 (UMLS CUI [1,2])
C1553480 (UMLS CUI [1,3])
16. The subject has claustrophobia that may be aggravated by entering the plethysmography cabinet (American Association of Respiratory Care 2001 guidelines for body plethismography)
Item
16. The subject has claustrophobia that may be aggravated by entering the plethysmography cabinet (American Association of Respiratory Care 2001 guidelines for body plethismography)
boolean
C0008909 (UMLS CUI [1])
C0032221 (UMLS CUI [2])
17. The subject has a known allergy or hypersensitivity to ipratropium bromide, tiotropium bromide, atropine and any of it's derivates.
Item
17. The subject has a known allergy or hypersensitivity to ipratropium bromide, tiotropium bromide, atropine and any of it's derivates.
boolean
C0020517 (UMLS CUI [1,1])
C0700580 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1306772 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0004259 (UMLS CUI [3,2])
18. The subject has a known allergy or hypersensitivity to the excipient lactose monohydrate.
Item
18. The subject has a known allergy or hypersensitivity to the excipient lactose monohydrate.
boolean
C0020517 (UMLS CUI [1,1])
C1658042 (UMLS CUI [1,2])