ClinicalTrials.Veeva

Menu

Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma

Novartis logo

Novartis

Status and phase

Completed
Phase 2

Conditions

Asthma

Treatments

Drug: placebo to indacaterol maleate/mometasone furoate
Drug: indacaterol maleate / mometasone furoate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00605306
CQMF149A2203

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

28 participants in 2 patient groups, including a placebo group

indacaterol maleate/mometasone furoate
Experimental group
Description:
Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
Treatment:
Drug: indacaterol maleate / mometasone furoate
Placebo
Placebo Comparator group
Description:
Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
Treatment:
Drug: placebo to indacaterol maleate/mometasone furoate

Trial contacts and locations

3

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems