Trial Outcomes & Findings for Acute Effect of Mometasone on Beta-adrenergic Airway and Airway Vascular Relaxation in Severe Asthma (NCT NCT01210170)

NCT ID: NCT01210170

Last Updated: 2017-11-21

Results Overview

FEV1 will be measured before and after inhalation of 180 mcg albuterol.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: 15 minutes after albuterol inhalation
• Results posted on: 2017-11-21

Participant Flow

Participant milestones

Measure	All Study Participants • Inhalation of 400 µg mometasone DPI 30 min before inhalation of 180 µg albuterol Mometasone furoate: • Inhalation of 400 µg mometasone or placebo DPI 30 min before inhalation of 180 µg albuterol • Inhalation of 400 µg mometasone or placebo DPI 60 min before inhalation of 180 µg albuterol
Overall Study STARTED	22
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acute Effect of Mometasone on Beta-adrenergic Airway and Airway Vascular Relaxation in Severe Asthma

Baseline characteristics by cohort

Measure	All Study Participants n=15 Participants • participant with asthma were enrolled in the study
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants

PRIMARY outcome

Timeframe: 15 minutes after albuterol inhalation

Population: As specified by the protocol, -60 minutes values were not to be analyzed if 200 mcg and 400 mcg of mometasone given 30 minutes before albuterol were determined to have no effect

FEV1 will be measured before and after inhalation of 180 mcg albuterol.

Outcome measures

Measure	All Participants Received 400 mcg Mometasone-30 Min n=15 Participants mometasone 400 mcg 30 minutes before albuterol 180 mcg inhalation	All Participants Received Placebo 30 Minutes Before Albuterol n=15 Participants mometasone placebo 30 minutes before albuterol 180 mcg inhalation	All Participants Received 400 mcg Mometasone Simultaneous n=15 Participants inhalation of 400 mcg mometasone immediately before inhalation of 180 mcg albuterol	All Participants Received Placebo Simultaneously With Albutero n=15 Participants inhalation of mometasone placebo immediately before inhalation of 180 mcg albuterol.	All Participants Received 200 mcg Mometasone-30 Min n=15 Participants mometasone 200 mcg 30 minutes before inhalation of 180 mcg of albuterol	All Participants Received 400 mcg -60 Min n=15 Participants mometasone 400 mcg 60 minutes before inhalation of 180 mcg of albuterol	All Participants Received Placebo -60 Min n=15 Participants placebo 60 minutes before inhalation of 180 mcg of albuterol	All Participants Received 200 mcg Mometasone Simultaneous n=15 Participants inhalation of mometasone placebo immediately before inhalation of 180 mcg albuterol	All Participants Received 200 mcg -60 Min n=15 Participants mometasone 200 mcg 60 minutes before inhalation of 180 mcg of albuterol
Albuterol-induced Change in FEV1	0.27 liters Standard Error 0.04	0.18 liters Standard Error 0.04	0.32 liters Standard Error 0.04	0.20 liters Standard Error 0.05	0.23 liters Standard Error 0.04	NA liters Standard Error NA Prespecified data were not analyzed due to the -30min results	NA liters Standard Error NA were not analyzed due to the -30min results	NA liters Standard Error NA were not analyzed due to the -30min results	NA liters Standard Error NA were not analyzed due to the -30min results

SECONDARY outcome

Timeframe: change in Qaw 15 minutes after albuterol inhalation

Population: As specified by the protocol, -60 minutes values were not to be analyzed if 200 mcg and 400 mcg of mometasone given 30 minutes before albuterol were determined to have no effect

Qaw will be measured before and 15 min after albuterol inhalation

Outcome measures

Measure	All Participants Received 400 mcg Mometasone-30 Min n=15 Participants mometasone 400 mcg 30 minutes before albuterol 180 mcg inhalation	All Participants Received Placebo 30 Minutes Before Albuterol n=15 Participants mometasone placebo 30 minutes before albuterol 180 mcg inhalation	All Participants Received 400 mcg Mometasone Simultaneous n=15 Participants inhalation of 400 mcg mometasone immediately before inhalation of 180 mcg albuterol	All Participants Received Placebo Simultaneously With Albutero n=15 Participants inhalation of mometasone placebo immediately before inhalation of 180 mcg albuterol.	All Participants Received 200 mcg Mometasone-30 Min n=15 Participants mometasone 200 mcg 30 minutes before inhalation of 180 mcg of albuterol	All Participants Received 400 mcg -60 Min n=15 Participants mometasone 400 mcg 60 minutes before inhalation of 180 mcg of albuterol	All Participants Received Placebo -60 Min n=15 Participants placebo 60 minutes before inhalation of 180 mcg of albuterol	All Participants Received 200 mcg Mometasone Simultaneous n=15 Participants inhalation of mometasone placebo immediately before inhalation of 180 mcg albuterol	All Participants Received 200 mcg -60 Min n=15 Participants mometasone 200 mcg 60 minutes before inhalation of 180 mcg of albuterol
Albuterol Induced Percent Change in Qaw	18 percent change in Qaw Standard Error 3	0 percent change in Qaw Standard Error 3	30 percent change in Qaw Standard Error 7	-2 percent change in Qaw Standard Error 3	NA percent change in Qaw Standard Error NA data not analyzed	NA percent change in Qaw Standard Error NA data not analyzed	NA percent change in Qaw Standard Error NA data not analyzed	NA percent change in Qaw Standard Error NA data not analyzed	NA percent change in Qaw Standard Error NA data not analyzed

Adverse Events

All Study Participants

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

Adam Wanner, MD

University of Miami

Phone: (305) 243-2568

Email: awanner@med.miami.edu

Results disclosure agreements

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