Phase 2
Completed N=80
Efficacy and Safety of Indacaterol Acetate Delivered Via the Concept1 Inhalation Device in Children Greater or Equal to 6 and Less Than 12 Years of Age With Asthma
Source: ClinicalTrials.gov NCT02892019 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Trough Forced Expiratoty Volume in 1 Second (FEV1) — 0.171; 0.212 L
Summary
This study is designed to explore lung function effects of two doses of indacaterol acetate, 75 μg and 150 μg, in pediatric asthma patients 6-11 years old, and to compare the systemic exposure to indacaterol in plasma with historical data in adults, to identify an appropriate dose to Phase III evaluation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratoty Volume in 1 Second (FEV1) |
0.171; 0.212 | — |
| SECONDARY Systemic Exposure to Indacaterol in Plasma |
0.0; 0.0; 204.1; 73.7; 125.8; 43.9 | — |
| SECONDARY Asthma Control as Assessed by Pediatric Interviewer-administered Asthma Control Questionnaire |
-0.375; -0.270 | — |
| SECONDARY Pre-dose Morning and Evening Peak Expiratoty Flow (PEF) |
29.6; 14.7; 29.7; 15.2 | — |
| SECONDARY Rescue Medication Usage (Mean Daiily Number of Puffs) |
-0.19; -0.22 | — |
| SECONDARY Rescue Medication Usage (Percentage of Rescue Medication Free Days) |
7.4; 3.1 | — |
| SECONDARY Forced Expiratoty Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) |
0.234; 0.224; 0.224; 0.258 | — |
| SECONDARY Symptoms as Recorded by Patient E-diary (Mean Total Daily Symptom Score) |
-0.18; 0.08 | — |
| SECONDARY Symptoms as Recorded by Patient E-diary (Percentage of Asthma Symptoms Free Days) |
12.3; 4.4 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female children ≥ 6 years and < 12 years with confirmed diagnosis of asthma for at least 1 year prior to study enrollment.
- Written informed consent by parent(s)/legal guardian(s) and depending upon their age and local requirements a consent or assent for the patient.
- Patients receiving daily treatment with a stable low dose Inhaled Corticosteroid (ICS) (with or without additional controller), or patients receiving daily treatment with a stable mid-dose ICS (monotherapy or together with LTRA) for at least 4 weeks prior to Screening, and able to tolerate fluticasone propionate 100 μg b.i.d. inhaler starting at Visit 1 (or soon after).
- Patients with a pre-bronchodilator FEV1 ≥ 50% and ≤ 90% of the predicted normal value for the patient at the start and end of Run-in (Visits 101 and 199).
- Patients who demonstrate an increase in FEV1 of 12% within 30 minutes after administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at Visit 101. All patients must perform a reversibility test at Visit 101.
Exclusion Criteria
- Patients taking a mid-dose ICS (per GINA guidelines) in combination with LABA or any patient taking high-dose ICS.
- Evidence of unstable disease within 4 weeks prior to Screening (Visit 1).
- Patients who have had an asthma attack/exacerbation requiring systemic steroids (SCS) or hospitalization or emergency room visit within 3 months prior to Visit 1 (Screening) or more than 3 separate exacerbations in the 12 months preceding Visit 1.
- Suspected or documented bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Screening (Visit 1).
- Prior intubation for asthma.
Data sourced from ClinicalTrials.gov (NCT02892019). 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.