Bronchodilatory Efficacy of a Single Dose QMF149 Via a Multiple-Dose Dry Powder Inhaler (MDDPI) in Adult Asthma Patients
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: QMF149 + matched placebo followed by an open label arm of fluticasone/salmeterol (Drug); matched placebo + QMF149 followed by an open label arm of fluticasone/salmeterol (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Principal Investigator, Affiliation: Novartis investigator site
Summary
This study is designed to evaluate the bronchodilatory efficacy of QMF149 via a MDDPI device
in adult patients with persistent asthma.
Clinical Details
Official title: An Exploratory, Multi-Centre, Double-Blind, Placebo Controlled Crossover Study, to Investigate the Bronchodilatory Efficacy of a Single Dose of Indacaterol in Fixed Combination With Mometasone Furoate Delivered Via a MDDPI (Twisthaler) in Adult Patients With Persistent Asthma Using Open Label Salmeterol/Fluticasone(50/250 Mcg b.i.d.) as an Active Control
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study
Primary outcome: Trough forced expiratory volume in one second (FEV1) change from baseline
Secondary outcome: Peak forced expiratory volume in one second (FEV1) change from baselineFEV1, forced vital capacity (FVC) and FEV1/FVC ratio Pharmacokinetics
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male and female adult patients aged 18-75 years with persistent asthma
- BMI between18 and 32 and weight >50 kg
- Subjects using local contraception
Exclusion Criteria:
- Pregnant or nursing women
- Recent use of tobacco or history of heavy smoking
- Patients diagnosed with COPD
- Patients with recent experience of severe asthma attack/exacerbation
- Patients with frequent rescue medication
- Clinically relevant laboratory abnormality or a clinically significant condition
- Active cancer or a history of cancer with less than 5 years disease free survival
time
- History of long QT syndrome or with long QTc interval prior to dosing
- History of hypersensitivity to the study drugs or to drugs with similar chemical
structures
- Patients who have had live attenuated vaccinations within 30 days
- Use of certain medications
- Use of other investigational drugs
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
- History of immunodeficiency diseases, including a positive HIV test result.
- History of drug or alcohol abuse or evidence of such abuse
- Donation or loss of 400 ml or more of blood
- In custody due to an administrative or a legal decision, or under tutelage, or being
admitted to a sanitary or social institution.
- Any staff directly involved in the conduct of the protocol
Other protocol-defined inclusion/exclusion criteria may apply.
Locations and Contacts
Novartis Investigator Site, Basel, Switzerland
Additional Information
Starting date: October 2007
Ending date: April 2008
Last updated: June 9, 2008
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