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Trial Outcomes & Findings for Inhaled Corticosteroids Versus Observation for Patients With Decreased Lung Function Status (NCT NCT00656916)

NCT ID: NCT00656916

Last Updated: 2012-04-23

Results Overview

Lung function non deterioration rate defined by change of forced expiratory volume in one second (FEV1) of \< 20%. FEV1, maximal amount of air forcefully exhaled in 1 second, converted to percentage of normal, calculated from a pulmonary function test (PFT) performed at baseline and three months.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Baseline and three months

Results posted on

2012-04-23

Participant Flow

Recruitment Period: 03/24/08 through 12/15/10. All participants recruited at UT MD Anderson Cancer Center.

Study terminated due to slow accrual.

Participant milestones

Participant milestones
Measure
Fluticasone Propionate
440 micrograms twice daily by oral inhalation.
Observation
Comparator group, no intervention.
Overall Study
STARTED
1
0
Overall Study
COMPLETED
1
0
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Inhaled Corticosteroids Versus Observation for Patients With Decreased Lung Function Status

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Fluticasone Propionate
n=1 Participants
440 micrograms twice daily by oral inhalation.
Observation
Comparator group, no intervention.
Total
n=1 Participants
Total of all reporting groups
Age Continuous
46 years
FULL_RANGE 0 • n=99 Participants
—
46 years
n=206 Participants
Gender
Female
1 participants
n=99 Participants
—
1 participants
n=206 Participants
Gender
Male
0 participants
n=99 Participants
—
0 participants
n=206 Participants
Region of Enrollment
United States
1 participants
n=99 Participants
—
1 participants
n=206 Participants

PRIMARY outcome

Timeframe: Baseline and three months

Population: There was no analysis performed for the protocol due the low enrollment (one participant).

Lung function non deterioration rate defined by change of forced expiratory volume in one second (FEV1) of \< 20%. FEV1, maximal amount of air forcefully exhaled in 1 second, converted to percentage of normal, calculated from a pulmonary function test (PFT) performed at baseline and three months.

Outcome measures

Outcome data not reported

Adverse Events

Fluticasone Propionate

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Observation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lara Bashoura, MD / Assistant Professor

UT MD Anderson Cancer Center

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place