anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: ACARBOSE
Trial phase: Phase 4
ATC code: A10BD17 | A10BF01
SMILES: [H]C(=O)[C@H](O)[C@@H](O)[C@]([H])(O[C@@]1([H])O[C@H](CO)[C@@]([H])(O[C@H]2O[C@H](C)[C@@H](N[C@@]3([H])C=C(CO)[C@@H](O)[C@H](O)[C@H]3O)[C@H](O)[C@H]2O)[C@H](O)[C@H]1O)[C@H](O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 244
Group description: Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
Eligibility criteria:
Inclusion Criteria:

Diagnosed with type 2 diabetes mellitus
Men and women (non-pregnant and using a medically approved birth-control method) aged at least 18 years at screening.
T2D patients treated with stable metformin monotherapy for at least 8 weeks prior to screening. Metformin dose should be ≥ 1500 mg/day (or individual maximally tolerated dose), but not more than the maximum dose specified in the label
HbA1c ≥ 7.5% and ≤ 11.0% at screening or within 4 weeks prior to screening (by local laboratory) and HbA1c ≥ 7.0% and ≤ 11.0% at pre-randomization visit (by central laboratory)
FPG ≤ 13.3 mmol/L (≤ 240 mg/dL) at pre-randomization visit (by central laboratory)
Able and willing to provide written informed consent and to comply with the study protocol

Exclusion Criteria:

Women who are pregnant, intending to become pregnant during the study period, lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods.

Diagnosis or history of:

Type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary forms of diabetes, eg, acromegaly or Cushing's syndrome.
Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months.
Previous treatment with any dipeptidyl peptidase-4 (DPP4) inhibitor or GLP-1 receptor agonists within the past one year.
History of hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to dipeptidyl peptidase-4 inhibitor (DPP4) or Acarbose.
Treatment with any anti-diabetic medication for more than 7 consecutive days other than metformin in the last 8 weeks prior to screening
Intervention: Pibrentasvir
Trial phase: Phase 2 | Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.
Eligibility criteria:
Inclusion Criteria:

Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection.
Chronic HCV infection.
Participant had to be either HCV treatment-naïve or treatment-experienced.
Participant had to be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only).

Exclusion Criteria:

History of severe, life-threatening or other significant sensitivity to any drug.
Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
Intervention: Pibrentasvir
Trial phase: Phase 2 | Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
Eligibility criteria:
Inclusion Criteria:

Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection.
Chronic HCV infection.
Participant had to be either HCV treatment-naïve or treatment-experienced.
Participant had to be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only).

Exclusion Criteria:

History of severe, life-threatening or other significant sensitivity to any drug.
Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
Intervention: Pibrentasvir
Trial phase: Phase 2 | Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
Eligibility criteria:
Inclusion Criteria:

Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection.
Chronic HCV infection.
Participant had to be either HCV treatment-naïve or treatment-experienced.
Participant had to be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only).

Exclusion Criteria:

History of severe, life-threatening or other significant sensitivity to any drug.
Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
Intervention: Pibrentasvir
Trial phase: Phase 2 | Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.
Eligibility criteria:
Inclusion Criteria:

Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection.
Chronic HCV infection.
Participant had to be either HCV treatment-naïve or treatment-experienced.
Participant had to be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only).

Exclusion Criteria:

History of severe, life-threatening or other significant sensitivity to any drug.
Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
Intervention: Pibrentasvir
Trial phase: Phase 2 | Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 145
Group description: ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.
Eligibility criteria:
Inclusion Criteria:

Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection.
Chronic HCV infection.
Participant had to be either HCV treatment-naïve or treatment-experienced.
Participant had to be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only).

Exclusion Criteria:

History of severe, life-threatening or other significant sensitivity to any drug.
Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
Intervention: Pibrentasvir
Trial phase: Phase 2 | Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 58
Group description: ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
Eligibility criteria:
Inclusion Criteria:

Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection.
Chronic HCV infection.
Participant had to be either HCV treatment-naïve or treatment-experienced.
Participant had to be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only).

Exclusion Criteria:

History of severe, life-threatening or other significant sensitivity to any drug.
Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
Intervention: Probenecid
Trial phase: Early Phase 1
ATC code: G01AE10 | M04AB01
SMILES: CCCN(CCC)S(=O)(=O)c1ccc(C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: These patients will receive 5 days of probenecid.

Probenecid: Treatment
Eligibility criteria:
Inclusion Criteria:

Age >21 years,
CPPD diagnosed by Ryan /McCarty criteria
Joint effusion in a shoulder or knee

Exclusion Criteria:

Inability to sign informed consent
Age <21 years
History of renal stones
Significant renal dysfunction (CKD >stage 2)
Blood dyscrasias
Current use of drugs which interact with probenecid
Concurrent gout
Active infection, including bacteremia and overlying cellulitis
Recent joint trauma
Intra-articular corticosteroids in the affected joint within three months
Intervention: Sugammadex
Trial phase: Phase 4
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Subjects in this arm will be reversed with sugammadex 2-4 mg/kg

Sugammadex
Eligibility criteria:
Inclusion Criteria:

Age 18 years
- BMI < 35
-ASA class I- III

-Patients scheduled for surgery requiring general anesthesia with the use of NMBA's

Patients with ability to give oral and written informed consent

Exclusion Criteria:

Failure to meet the inclusion criteria

-Known or suspected neuromuscular disorders impairing neuromuscular function
-Allergies to muscle relaxants, anesthetics or narcotics

A (family) history of malignant hyperthermia

-Women who are or may be pregnant or are currently breast feeding
-Contraindications for the use of neostigmine
Intestinal obstruction,

COPD GOLD 4

-Abnormal heart rhythm (eg. bradycardia: < 40/min);
-Surgery requiring neuraxial anesthesia / analgesia
-Preoperative cognitive dysfunction or mental disabilities
-Preexistent significant pulmonary disease with preoperative SpO2 < 90%
-Preoperative ICU treatment / intubation (ICU patient);
-Need for postoperative ICU treatment or ventilation;
Intervention: Neostigmine
Trial phase: Phase 4
ATC code: N07AA01 | N07AA51 | S01EB06
SMILES: CN(C)C(=O)Oc1cccc([N+](C)(C)C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg

Neostigmine
Eligibility criteria:
Inclusion Criteria:

Age 18 years
- BMI < 35
-ASA class I- III

-Patients scheduled for surgery requiring general anesthesia with the use of NMBA's

Patients with ability to give oral and written informed consent

Exclusion Criteria:

Failure to meet the inclusion criteria

-Known or suspected neuromuscular disorders impairing neuromuscular function
-Allergies to muscle relaxants, anesthetics or narcotics

A (family) history of malignant hyperthermia

-Women who are or may be pregnant or are currently breast feeding
-Contraindications for the use of neostigmine
Intestinal obstruction,

COPD GOLD 4

-Abnormal heart rhythm (eg. bradycardia: < 40/min);
-Surgery requiring neuraxial anesthesia / analgesia
-Preoperative cognitive dysfunction or mental disabilities
-Preexistent significant pulmonary disease with preoperative SpO2 < 90%
-Preoperative ICU treatment / intubation (ICU patient);
-Need for postoperative ICU treatment or ventilation;
Intervention: Ezetimibe
Trial phase: Phase 2
ATC code: C10AX09 | C10BA02 | C10BA05 | C10BA06 | C10BA10 | C10BA11 | C10BA12
SMILES: [H][C@]1(CC[C@H](O)c2ccc(F)cc2)C(=O)N(c2ccc(F)cc2)[C@]1([H])c1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Ursodiol (URSO Forte) 13-15 mg per kg (250-500 mg b.i.d. or t.i.d depending on body weight) combined with Ezetimibe (Zetia) 10 mg o.p.d.

EZ-Urso combination therapy: Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day
Eligibility criteria:
Inclusion Criteria:

Steatosis
ALT >1.5 times normal
ALT/AST ratio >1.0
Normal Kidney Function

Exclusion Criteria:

Normal ALT within last 6 months
Advanced fibrosis based on 1) biopsy, if available (Stage 3 or 4 NAFLD), 2) imaging, or 3) lab (platelet count <150,000)
Daily alcohol use above 20 g/day for women and 30 g/day for men
Prescription use of ursodiol, ezetimibe, vitamin E, fish oils, thiazolidinediones, insulin, sulfonylureas, HMG-CoA reductase inhibitors
Weight loss greater than 15% in past 12 months
Pregnant or breastfeeding
Body Mass index greater than 50
Largest body circumference greater than 160 cm
Claustrophobia
Allergy to ezetimibe or ursodiol
Intervention: LOTEPREDNOL ETABONATE
Trial phase: Not Applicable
ATC code: S01BA14
SMILES: [H][C@@]12CC[C@](OC(=O)OCC)(C(=O)OCCl)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: KPI-121 1.0% Ophthalmic Suspension dosed QID for 4 weeks in subjects with Retinal Vein Occlusion or Diabetic Macular Edema

KPI-121 1.0% Ophthalmic Suspension: KPI-121 drug product will be supplied a 1.0% loteprednol etabonate as a suspension packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
Eligibility criteria:
Inclusion Criteria:

Have documented presence of intraretinal or subretinal fluid secondary to Retinal Vein Occlusion or Diabetic Macular Edema at Screening

Exclusion Criteria:

Treatment with topical, intravitreal injection, posterior sub-Tenon's, or periocular corticosteroids within 120 days prior to Visit 1 and for the duration of the study
History of uncontrolled glaucoma, IOP over 21 mmHg at Visit 1, or are being treated for glaucoma in the study eye
Any significant ocular disease that could compromise vision in the study eye (including ongoing ocular infection, wet age-related macular degeneration, myopic degeneration with active subfoveal choroidal neovascularization)
Known hypersensitivity or contraindication to the investigational product(s) or their components
Diagnosis of severe/serious ocular condition that in the judgment of the Investigator could confound study assessments or limit compliance; or severe/serious systemic disease or uncontrolled medical condition that in the judgment of the Investigator could confound study assessments or limit compliance
Exposed to an investigational drug within 30 days prior to Visit 1 and for the duration of the study
In the opinion of the Investigator or study coordinator, an unwillingness or inability to comply with the study protocol or inability to successfully instill eye drops
Intervention: Leucomethylene Blue dimesylate
Trial phase: Phase 3
SMILES: CN(C)c1ccc2c(c1)Sc1cc(N(C)C)ccc1N2.CS(=O)(=O)O.CS(=O)(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 896
Group description: The initial LMTM dose was 200 mg/day (one 100-mg tablet twice daily), except in subjects with bvFTD who were taking a reduced dose (i.e., 100 mg/day) upon entering this extension study. The dose could be increased (after at least 13 weeks of treatment) or decreased (at any time at or after 2 weeks of treatment) by the Investigator in 100-mg increments or decrements. The maximum allowable dose was 300 mg/day (or in those countries where limited by a Competent Authority or Ethics Committee, 200 mg/day).
Eligibility criteria:
Inclusion Criteria:

Subjects with all cause dementia and probable Alzheimer's disease at enrollment and who completed participation in one of the following three TauRx studies (inclusive of the 4-week post-treatment follow-up visit): TRx-237-005, TRx-237-008, or TRx-237-015.
Subjects with a diagnosis of probable bvFTD at enrollment and who completed participation in TauRx study TRx-237-007 through Visit 9 (Week 52).
Females, if of child-bearing potential, must practice true abstinence or continue to use adequate contraception and agree to maintain this throughout the study
Subject, and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law and ethics approval is/are able to read, understand, and provide written informed consent
Has an identified adult caregiver who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥1 hour/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug
Able to comply with the study procedures

Exclusion Criteria:

History of swallowing difficulties
Pregnant or breastfeeding
Clinically significant laboratory, pulse co-oximetry, electrocardiogram, or imaging abnormality (in originating study) or emergent intercurrent illness that, in the judgment of the principal investigator, could result in the risk of participation outweighing the potential benefit
Current participation in, or intent to enroll in, another clinical trial of a drug, biologic, device, or medical food
In Germany, subjects mandated to reside in a continuous care or assisted living facility or those whose willingness to participate in the clinical trial may be unduly influenced
Intervention: Viani
Trial phase: Phase 3
SMILES: CCC(=O)OC1(C(=O)SCF)C(C)CC2C3CC(F)C4=CC(=O)C=CC4(C)C3(F)C(O)CC21C.OCc1cc(C(O)CNCCCCCCOCCCCc2ccccc2)ccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 512
Group description: Advair Diskus administered two times per day by inhalation throughout the study

Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device
Eligibility criteria:
Key inclusion criteria include:

Male or female subjects aged ≥18 years. Females may be of either childbearing or non-childbearing potential
Physician diagnosed history of asthma for at least 12 weeks prior to screening
pre-bronchodilator FEV1 60-85% at screening and other specified visits
Post-bronchodilator reversibility >/=12%
Non-smokers and prior smokers with no history of smoking within the past 12 months prior to screening and a total smoking history of ≤10 pack-years
Subjects able to discontinue asthma medications for the duration of the study and be maintained using albuterol as required
Body mass index between 18-40 kg/m2 inclusive

Key exclusion criteria include:

Presence or recent history of any other active, severe, progressive, and/or uncontrolled clinical disease, eg, poorly controlled Type 1 or 2 diabetes, seizure disorder or epilepsy, cerebrovascular accident, significant cardiac conduction abnormalities
Respiratory conditions other than asthma and allergic rhinitis, including but not limited to: severe nasal polyposis or chronic rhinosinusitis, chronic obstructive pulmonary disease, bronchiectasis, Churg-Strauss Disease, lung resection, pulmonary fibrosis (primary or secondary), pulmonary hypertension, cystic fibrosis, sarcoidosis
History of life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s)
In patient hospitalization (not including ER visits) for an asthma exacerbation within the past year or during the run in period
An asthma exacerbation requiring change in asthma therapy or oral/IV corticosteroids in the 3 months prior to screening
History of seasonally unstable asthma where the season will coincide with the subject's participation in the study
Use of prescription or non-prescription drugs, including beta blockers, tricyclic antidepressants, oral decongestants, benzodiazepines, digitalis, phenothiazines, monoamine oxidase inhibitors, etc
Suspected hypersensitivity to the study drugs (including lactose) or severe milk protein allergy
Clinically significant abnormalities in the screening ECG
Evidence of alcohol or drug abuse or dependency within 6 months prior to screening