Phase 2
Completed N=37
Investigation of the 24 Hour Forced Expiratory Flow in 1 Second (FEV1) Profile of a Single Dose of Indacaterol/Mometasone Delivered Via the TWISTHALER® Device in Adult Patients With Persistent Asthma
Source: ClinicalTrials.gov NCT00557440 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcomePrimary: Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) — 0.081; 0.049; -0.083 liters — p=0.001
Summary
This study is designed to provide data about the 24 hours FEV1 profile, safety and tolerability of indacaterol/mometasone TWISTHALER device compared to placebo and using fluticasone/salmeterol as an active control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) |
0.081; 0.049; -0.083 | 0.001 sig |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points |
2.713; 2.632; 2.554; 2.754; 2.719; 2.527 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours Post-dose |
2.730; 2.713; 2.469; 2.718; 2.679; 2.430 | — |
| SECONDARY Time to Peak Forced Expiratory Volume in 1 Second (FEV1) |
87.4; 67.7; 22.3 | — |
| SECONDARY Forced Vital Capacity (FVC) at Single Time Points |
3.917; 3.880; 3.830; 3.946; 3.933; 3.839 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female adult patients aged 18-75 years (inclusive), who have signed an Informed Consent Form prior to initiation of any study-related procedure,
- Patients with persistent asthma, diagnosed according to Global Initiative for Asthma (GINA) guidelines (National Institute of Health, National Heart, Lung and Blood Institute, 2006) and who additionally meet the following criteria:
- Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the product label, in a stable regimen for the month prior to Visit 1.
- Patients with an FEV1 at Visit 1 ≥50% of predicted normal.
- Patients who demonstrate an increase of ≥ 12% and ≥ 200 mL in FEV1 over their pre-bronchodilator.
Exclusion Criteria
- Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception.
- Patients who have used tobacco products within the 6 months period prior to Visit 1, or who have a smoking history of greater than 10 pack years.
- Patients diagnosed with Chronic Obstructive Pulmonary disease (COPD) as defined by the GOLD guidelines (Global Initiative for Chronic Obstructive Lung Disease 2006).
- Patients with seasonal allergy whose asthma is likely to deteriorate during the study period.
- Patients who have had an acute asthma attack/exacerbation requiring hospitalization in the 6 months prior to Visit 1.
- Patients who have had an acute asthma attack / exacerbation requiring an emergency room visit within 6 weeks prior to Visit 1 or at any time between Visit 1 and Visit 2.
- Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1 or at any time between Visit 1 and Visit 2.
- Patients with a history of long QT interval syndrome or whose QT interval corrected for heart rate (QTc) interval (Bazett's) measured at Visit 1 or Visit 2 is prolonged: > 450 ms (males) or > 470 ms (females).
- Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00557440). 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.