Safety and Tolerability of QMF149 After 14 Days Treatment in Patients With Mild to Moderate Asthma - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00605306

Purpose

This study will investigate the safety and tolerability of QMF149 after 14 days treatment in patients with mild to moderate asthma.

Condition	Intervention	Phase
Asthma	Drug: QMF149 Drug: Placebo	Phase II

MedlinePlus related topics: Asthma

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Safety and Tolerability of 14-Days Treatment With an Inhaled Dose of QMF149 (500/800) in Mild to Moderate Asthmatic Patients

Further study details as provided by Novartis:

Primary Outcome Measures:

Forced expiratory volume in 1 second (FEV1) on Days 1 and 14 [ Time Frame: throughout the study ]

Secondary Outcome Measures:

Level of potassium, glucose and cortisol in blood [ Time Frame: throughout the study ]
Quality of life assessed by CASIS (COPD [chronic obstructive pulmonary disease] and Asthma Sleep Impact Scale) and CAFS (COPD and Asthma Fatigue Scale) at baseline and Day 14 [ Time Frame: throughout the study ]

Estimated Enrollment:	24
Study Start Date:	January 2008
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: QMF149
2: Placebo Comparator	Drug: Placebo

Eligibility

Criteria

Inclusion Criteria:

Male and female adult patients aged 18-65 years (inclusive)
Patients with mild-moderate asthma
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.
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 COPD
Patients who have been hospitalized or had emergency treatment for an asthma attack in the 6 months prior to study start
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 HIV
A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
History of drug or alcohol abuse within 12 months of study start

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605306

Locations

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

NOVARTIS

Novartis investigator site

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CQMF149A2203
Study First Received:	January 18, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00605306
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Novartis:

Asthma
spirometry
lung function

serum cortisol
serum potassium
plasma glucose

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Hydrocortisone
Cortisol succinate
Respiratory Tract Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Hydrocortisone acetate
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 14, 2009