Phase 2
Completed N=53
A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects
Source: ClinicalTrials.gov NCT00583947 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcomePrimary: Mean Heart Rate — 87.6; 84.7; 87.0; 89.3 beats per minute
Summary
To determine the safety and tolerability of Arformoterol Tartrate in children with asthma
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Heart Rate |
87.6; 84.7; 87.0; 89.3; 85.2; 89.4 | — |
| PRIMARY Change From Predose in Mean Heart Rate |
1.6; 0.5; 2.3; 3.2; 2.0; 2.5 | — |
| PRIMARY Mean Systolic Blood Pressure |
102.1; 101.5; 100.6; 102.9; 101.2; 102.6 | — |
| PRIMARY Change From Predose in Mean Systolic Blood Pressure |
0.8; -0.4; 2.0; 2.6; 0.9; -0.3 | — |
| PRIMARY Mean Diastolic Blood Pressure |
62.5; 63.2; 63.6; 61.4; 62.0; 62.5 | — |
| PRIMARY Change From Predose in Mean Diastolic Blood Pressure |
-1.1; -1.1; -1.0; -1.7; -0.6; -1.9 | — |
| PRIMARY Mean Serum Potassium Levels |
4.25; 4.27; 4.31; 3.67; 3.83; 3.71 | — |
| PRIMARY Change From Predose in Mean Serum Potassium |
-0.58; -0.42; -0.62; -0.23; -0.31; -0.39 | — |
| PRIMARY Mean Serum Glucose Values |
86.4; 87.5; 87.6; 114.5; 108.6; 120.6 | — |
| PRIMARY Change From Predose in Mean Serum Glucose |
27.1; 22.4; 32.9; 20.3; 12.1; 18.6 | — |
| SECONDARY Mean Forced Expiratory Volume in One Second(FEV1) |
1.554; 1.552; 1.486; 1.714; 1.668; 1.620 | — |
| SECONDARY Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) |
0.160; 0.117; 0.133; 0.159; 0.142; 0.158 | — |
| SECONDARY Mean Peak Expiratory Flow Rate (PEFR) |
3.604; 3.546; 3.565; 3.926; 3.788; 3.824 | — |
| SECONDARY Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) |
0.322; 0.242; 0.259; 0.399; 0.320; 0.279 | — |
| SECONDARY Plasma Concentration of (R,R) Formoterol |
0.646; 0; 0.737; 2.402; 2.236; 1.659 | — |
Eligibility Criteria
Inclusion Criteria
- Male and Female
- Between Age 2 and 11, inclusive, at the time of consent
- Weight equal to or greater than 15 Kg
- History of physician-diagnosed asthma of at least 2 years duration for children age 6 and older, and at least 1 year duration for children 5 and younger.
Exclusion Criteria
- Female subject who is pregnant or lactating.
- Subject who has a history of hospitalization for asthma within one year, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial.
- Subject with any history of life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures.
- Subject with a history of cancer.
- Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders.
- Subject with a history of cigarette smoking or use of any tobacco products.
Data sourced from ClinicalTrials.gov (NCT00583947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.