NCT01111110

Brief Summary

Delivery of HFA albuterol through an antistatic valved holding chamber (VHC) will improve bronchodilator response during nocturnal bronchospasm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2010

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

June 19, 2012

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

April 23, 2010

Results QC Date

January 10, 2012

Last Update Submit

February 3, 2022

Conditions

Asthma

Outcome Measures

Primary Outcomes (3)

  • Y=100([FEV1 at 1 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.

    (Percent improvement in FEV1 (Forced Expiratory Volume and Forced Vital Capacity) Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 1 Puff go into chamber

    fifteen minutes after 1 puff of albuterol

  • Y=100([FEV1 at 2 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.

    (Percent improvement in FEV1(Forced Expiratory Volume and Forced Vital Capacity) Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 2 Puffs go into chamber

    15 minutes after 2 puffs of albuterol

  • Y=100([FEV1 at 4 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.

    (Percent improvement in FEV1 (Forced Expiratory Volume and Forced Vital Capacity) Post Dose for Period 2 over 4AM Baseline value)less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 4 Puffs go into chamber

    fifteen minutes after 4 puffs of albuterol

Study Arms (2)

Anti-static then Static for Albuterol

EXPERIMENTAL

albuterol anti-static first then static chamber second.

Device: anti-static then static

Static then Anti-static for Albuterol

EXPERIMENTAL

static then antistatic albuterol

Device: Static then anti-static chamber

Interventions

anti-static then staticDEVICE

Albuterol using static chambers

Anti-static then Static for Albuterol
Static then anti-static chamberDEVICE

albuterol with Static then anti-static chambers

Static then Anti-static for Albuterol

Eligibility Criteria

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

You may qualify if:

  • Age 18-65 years.
  • Physician diagnosis of asthma.
  • FEV1 60-80% predicted during the day.
  • FEV1 increases ≥ 12 % and to ≥ 80% predicted after 2- 4 puffs of albuterol HFA MDI delivered by antistatic VHC.
  • No smoking in the previous year and \< 10-pack year history.
  • No history of severe asthma attacks requiring ER visit or hospitalization in the previous three months.

You may not qualify if:

  • Patient required a short course of oral steroid in the past 30 days.
  • Any disease that is inadequately controlled or any medication that would worsen asthma or interact with asthma medications.
  • History of viral respiratory tract infection in the 3 weeks prior to the screening visit.
  • Positive pregnancy test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Nocturnal asthma model is a very sensitive model, but very labor intensive and to get more completed subjects, we might need to do multicenter trial

Results Point of Contact

Title
Dr.Sreekala Prabhakaran. Clinical Assistant Professor Pediatrics
Organization
University of Florida
sprabhakaran@peds.ufl.edu
352-273-8381

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2010

First Posted

April 27, 2010

Study Start

May 1, 2008

Primary Completion

April 1, 2009

Study Completion

March 1, 2010

Last Updated

February 28, 2022

Results First Posted

June 19, 2012

Record last verified: 2022-02

Locations

US(1)