Phase 3
Completed N=350
A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 Hydrofluoroalkane (HFA) Versus Fluticasone Propionate 100 HFA In Children With Asthma
Source: ClinicalTrials.gov NCT00441441 ↗Enrolled (actual)
350
Serious AEs
0.3%
Results posted
Sep 2010
Primary outcomePrimary: Possible Drug-Related Adverse Events — 13; 16; 9; 4 participants
Summary
This study is to assess the safety of an investigational drug in children 4 to 11 years of age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests performed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Possible Drug-Related Adverse Events |
13; 16; 9; 4; 0; 2 | — |
| PRIMARY Investigator Evaluations of Electrocardiogram (ECG) Results |
145; 155; 27; 21; 1; 0 | — |
| PRIMARY Clinically Significant Unfavorable ECGs at Week 12 |
24; 18; 22; 18; 11; 11 | — |
| PRIMARY ECG Measures - Heart Rate |
84; 82.6; 85.5; 81.9; 73.1; 92.4 | — |
| PRIMARY ECG Measures - QT Interval |
394.5; 390.8; 397.5; 393.6; 392; 394.8 | — |
| PRIMARY Cardiovascular Adverse Events Reported During Treatment Period |
98; 103; 3; 2; 2; 1 | — |
| PRIMARY Cardiovascular Adverse Events Reported During the Post-Treatment Period |
19; 19; 11; 5; 1; 2 | — |
| PRIMARY Asthma Exacerbations: Worsening of Asthma Requiring Emergency Intervention, Hospitalization, or Treatment With Asthma Medications Prohibited by the Protocols |
1; 3; 1; 2; 0; 1 | — |
| PRIMARY Number of Participants With the Indicated Levels of 24-hour Urinary Cortisol Excretion |
13; 17; 1; 0; 13; 8 | — |
| PRIMARY Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12 |
32.71; 28.39; 25.03; 22.80 | — |
| PRIMARY Geometric Mean Ratio for Week12:Baseline for 24-hour Urinary Cortisol Excretion |
0.77; 0.75 | — |
| PRIMARY Number of Participants With the Indicated Levels of 24 Hour Urinary Cortisol Excretion by Spacer Use |
12; 1; 14; 3; 0; 1 | — |
| PRIMARY Geometric Mean Values of 24 Hour Urinary Cortisol Excretion by Spacer Use at Baseline and Week 12 |
31.89; 35.84; 30.61; 31.89; 23.37; 32.05 | — |
| PRIMARY Geometric Mean Ratio for Week12: Baseline for 24 Hour Urinary Cortisol Excretion by Spacer Use |
0.73; 0.89; 0.76; 0.72 | — |
| SECONDARY Clinic Morning (AM) Forced Expiratory Volume in Participants 6-11 Years |
1.67; 1.64; 1.91; 1.82; 0.24; 0.18 | — |
| SECONDARY AM Peak Expiratory Flow |
213; 203; 233; 220; 20.2; 17.4 | — |
| SECONDARY Asthma Symptom Scores |
1.3; 1.4; 0.9; 0.8; -0.4; -0.6 | — |
| SECONDARY Percentage of Symptom Free Days |
20.0; 18.4; 46.7; 48.7; 26.8; 30.5 | — |
| SECONDARY Albuterol Use |
1.5; 1.8; 1.0; 0.9; -0.6; -1.0 | — |
| SECONDARY Percent of Albuterol-free Days |
43.7; 42.5; 67.1; 70.0; 23.6; 28.3 | — |
Eligibility Criteria
Inclusion criteria
- Must have asthma.
- Must be currently taking an inhaled corticosteroid.
- Must be able to attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests that are at least 60% of normal (AM FEV1 or PEF).
- Have a historical or current FEV1 or PEF reversibility of >=12%.
Exclusion criteria
- Has ever had life-threatening asthma (for example respiratory arrest, mechanical ventilation).
- Has a current ear or respiratory tract infection.
- Has ever had any other major illnesses (such as cystic fibrosis, heart problems, tuberculosis).
Data sourced from ClinicalTrials.gov (NCT00441441). 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.