Phase 2
Completed N=28
Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma
Source: ClinicalTrials.gov NCT00605306 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcomePrimary: Participants With Adverse Events — 9; 12; 0; 0 participants
Summary
This study will investigate the safety and tolerability of indacaterol maleate/mometasone furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Adverse Events |
9; 12; 0; 0; 0; 1 | — |
| SECONDARY Levels of Serum Potassium Over Time |
4.271; 4.336; 4.264; 4.279; 4.293; 4.314 | — |
| SECONDARY Levels of Plasma Glucose Over Time |
5.079; 5.157; 5.057; 5.236; 5.007; 5.264 | — |
| SECONDARY Levels of Serum Cortisol Over Time |
466.214; 441.143; 159.643; 140.714; 153.786; 151.000 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female adult patients aged 18-65 years (inclusive)
- Patients with mild-moderate asthma
- Forced expiratory volume in one second (FEV1) at Visits 1 and 2 are ≥60% of the predicted normal value for the patient.
- Body mass index (BMI) must be within the range of 18-32 kg/m^2.
- Non-smokers or light smokers (≤10 cigarettes per day), with a smoking history of 10 pack years or less.
Exclusion Criteria
- Patients who suffer from chronic obstructive pulmonary disease (COPD)
- Patients who have been hospitalized or had emergency treatment for an asthma attack in the 6 months prior to study start
- QTcF interval > 450 msec in men and >470 msec in women
- Pregnant women or nursing mothers
- Females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable).
- History of immunocompromise, including a positive human immunodeficiency virus (HIV)
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- History of drug or alcohol abuse within 12 months of dosing
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00605306). 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.