Trials Sponsors Conditions Drugs Pricing

Conditions

Asthma

Keywords

Poorly Controlled Asthma

Outcome Measures

Primary Outcomes (1)

Change in post-inhalation percent-predicted FEF 25-75 (%) from baseline (week 0) to week 12
Final Visit

Secondary Outcomes (1)

Mean and mean change from pre-dose to 15-minute post-dose in percent predicted FEV1 (%) at week 12
week 12

Study Arms (2)

Qvar

EXPERIMENTAL

Qvar 160 mcg twice daily

Drug: Qvar

Flovent Diskus

ACTIVE COMPARATOR

Flovent Diskus 200 mcg twice daily

Drug: Flovent Diskus

Interventions

QvarDrug

Qvar (HFA-propelled beclomethasone dipropionate metered dose inhaler) 160 mcg twice daily for 12 weeks

Qvar

Flovent DiskusDrug

Flovent Diskus (fluticasone propionate multi-dose dry powder inhaler) 200 mcg twice daily for 12 weeks

Flovent Diskus

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age12 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Poorly controlled asthma;
Average use of over 2 puffs of albuterol per day in the previous 7 days OR Having symptoms of asthma on 5 of the last 7 days OR Awakening at night due to asthma at least once in the previous 7 days OR Having been treated with a course of oral or intravenous steroids at least once in the last 3 months.

Sponsors & Collaborators

Teva Branded Pharmaceutical Products R&D, Inc.
Industrylead

Study Sites (1)

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

MeSH Terms

Conditions

Asthma

Interventions

BeclomethasoneFluticasone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienes

Enrollment

49 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 28, 2003

First Posted

October 29, 2003

Study Start

January 31, 2004

Actual (reported)

Study Stopped

Efficacy of QVAR vs Flovent Diskus on Small Airways in Poorly Controlled Asthmatic Adolescents/Adult Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Qvar

Flovent Diskus

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Qvar

Flovent Diskus

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations