Bronchodilatory Efficacy of a Single Dose QMF149 Via a Multiple-Dose Dry Powder Inhaler (MDDPI) in Adult Asthma Patients - Full Text View

Sponsor:	Novartis
Collaborator:	Schering-Plough
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00556673

Purpose

This study is designed to evaluate the bronchodilatory efficacy of QMF149 via a MDDPI device in adult patients with persistent asthma.

Condition	Intervention	Phase
Asthma	Drug: 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	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Mometasone furoate Salmeterol Fluticasone Salmeterol xinafoate

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Trough forced expiratory volume in one second (FEV1) change from baseline [ Time Frame: throughout the study ]

Secondary Outcome Measures:

Peak forced expiratory volume in one second (FEV1) change from baseline [ Time Frame: throughout the study ]
FEV1, forced vital capacity (FVC) and FEV1/FVC ratio [ Time Frame: throughout the study ]
Pharmacokinetics [ Time Frame: throughout the study ]

Estimated Enrollment:	24
Study Start Date:	October 2007
Study Completion Date:	April 2008

Arms	Assigned Interventions
1: Active Comparator QMF149 + matched placebo followed by an open label arm of fluticasone/salmeterol	Drug: QMF149 + matched placebo followed by an open label arm of fluticasone/salmeterol
2: Active Comparator matched placebo +QMF149 followed by an open label arm of fluticasone/salmeterol	Drug: matched placebo + QMF149 followed by an open label arm of fluticasone/salmeterol

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556673

Locations

Switzerland
Novartis Investigator Site
Basel, Switzerland

Sponsors and Collaborators

Novartis

Schering-Plough

Investigators

Principal Investigator:

Novartis

Novartis investigator site

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CQMF149A2204
Study First Received:	November 9, 2007
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00556673 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Asthma, QMF149, fixed combination of indacaterol and mometasone furoate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Albuterol
Physiological Effects of Drugs
Reproductive Control Agents
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Tocolytic Agents
Respiratory Tract Diseases
Therapeutic Uses

Fluticasone
Dermatologic Agents
Salmeterol
Immune System Diseases
Adrenergic beta-Agonists
Mometasone furoate
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on February 09, 2010