NCT01103037

Brief Summary

This study will assess the safety and efficacy of QAV680 in patients with mild to moderate asthma

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2 asthma

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_2 asthma

Geographic Reach
3 countries

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

December 19, 2020

Status Verified

May 1, 2012

Enrollment Period

6 months

First QC Date

April 12, 2010

Last Update Submit

December 11, 2020

Conditions

Asthma

Keywords

MildModerateAsthma

Outcome Measures

Primary Outcomes (1)

  • Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry

    28 days

Secondary Outcomes (5)

  • FEV1 assessments at various timepoints including time of peak drug concentration

    28 days

  • Measure the change in exhaled Nitric Oxide (FeNO)

    28 days

  • Assessment of the pharmacokinetics of multiple doses of QAV680 in patients with mild to moderate asthma.

    28 days

  • Total serum IgE levels

    28 days

  • Change in daily variability in the morning and evening Peak Expiratory Flow Rate (PEFR) from Baseline.

    28 days

Study Arms (2)

QAV680

EXPERIMENTAL
Drug: QAV680

QAV680 Placebo

PLACEBO COMPARATOR
Drug: QAV680 Placebo

Interventions

QAV680DRUG

QAV680 500 mg (5 x 100 mg capsules) four times per day

QAV680
QAV680 PlaceboDRUG

Placebo to QAV680 5 capsules four times per day

QAV680 Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with moderate persistent asthma

You may not qualify if:

  • Smokers
  • Any significant disease or illness, other than asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

West Coast Clinical Trials

Cypress, California, 90630, United States

Location

American Health Research

Charlotte, North Carolina, 28207, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Novartis Investigative Site

Berlin, Germany

Location

Novartis Investigative Site

Hamburg, Germany

Location

Novartis Investigative Site

Wiesbaden, Germany

Location

Novartis Investigative Site

Moscow, Russia

Location

Related Links

MeSH Terms

Conditions

AsthmaLymphoma, Follicular

Interventions

NVP-QAV680

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative Disorders

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 13, 2010

Study Start

March 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

December 19, 2020

Record last verified: 2012-05

Locations

DE(3)US(3)RU(1)