A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma

Asthma Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Determine the Safety and Efficacy of AMG 827 in Subjects With Inadequately Controlled Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199289
• Other study ID #: 20090203
• Status: Completed
• Phase: Phase 2
• Start date: October 4, 2010
• Est. completion date: December 21, 2011

Study information

• Verified date: October 2021
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if AMG 827 is effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: December 21, 2011
• Est. primary completion date: December 21, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Men or women 18 to 65 years of age

• Percent of predicted FEV1 = 50% and = 80%

• At least 12% reversibility over pre-bronchodilator FEV1

• Inhaled corticosteroid (ICS) = 200 and = 1000 µg/day fluticasone powder or equivalent

• Ongoing asthma symptoms with ACQ composite score = 1.5 points

Exclusion Criteria:

• Respiratory infection within 4 weeks of screening visit or 1 week of baseline visit

• History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma

• Any uncontrolled or clinically significant systemic disease (eg, uncontrolled diabetes, liver disease)

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• AMG 827
SC injection.
• Placebo
SC injection.

Locations

Country	Name	City	State
Austria	Research Site	Feldbach
Austria	Research Site	Hallein
Austria	Research Site	Wien
Belgium	Research Site	Bruxelles
Belgium	Research Site	Leuven
Belgium	Research Site	Liege
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Toronto	Ontario
Finland	Research Site	Helsinki
Finland	Research Site	Jyväskylä
Finland	Research Site	Turku
Hungary	Research Site	Edeleny
Hungary	Research Site	Matrahaza
Hungary	Research Site	Tatabanya
Hungary	Research Site	Torokbalint
Hungary	Research Site	Zalaegerszeg - Pozva
Korea, Republic of	Research Site	Bucheon-si
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon
Netherlands	Research Site	Rotterdam
Poland	Research Site	Bialystok
Poland	Research Site	Chodziez
Poland	Research Site	Gdansk
Poland	Research Site	Wroclaw
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Saint Petersburg
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bellevue	Nebraska
United States	Research Site	Bozeman	Montana
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Dallas	Texas
United States	Research Site	El Paso	Texas
United States	Research Site	Encinitas	California
United States	Research Site	High Point	North Carolina
United States	Research Site	Huntington Beach	California
United States	Research Site	Lake Oswego	Oregon
United States	Research Site	Los Angeles	California
United States	Research Site	Madison	Wisconsin
United States	Research Site	Medford	Oregon
United States	Research Site	North Dartmouth	Massachusetts
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Rockville Centre	New York
United States	Research Site	Saint Louis	Missouri
United States	Research Site	San Diego	California
United States	Research Site	Skillman	New Jersey
United States	Research Site	Stockbridge	Georgia
United States	Research Site	Stockton	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Finland,  Hungary,  Korea, Republic of,  Netherlands,  Poland,  Russian Federation, 

References & Publications (1)

Busse WW, Holgate S, Kerwin E, Chon Y, Feng J, Lin J, Lin SL. Randomized, double-blind, placebo-controlled study of brodalumab, a human anti-IL-17 receptor monoclonal antibody, in moderate to severe asthma. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1294-302. doi: 10.1164/rccm.201212-2318OC. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12	The ACQ is an instrument used in clinical research and practice to evaluate asthma control/impairment.; It is a validated composite score that assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon awakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and forced expiratory volume in 1 second (FEV1).; The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/limitation) scale. The total score is obtained by adding the value from each question and dividing by the number of questions. Higher scores indicates worsening of condition and a negative change from baseline indicates improvement.	Baseline and Week 12
Secondary	Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. FEV1 was performed both pre and post-administration of bronchodilator treatment at Baseline and Week 12.	Baseline and Week 12
Secondary	Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) to Week 12		Baseline and Week 12
Secondary	Change From Baseline in the Frequency of Rescue Short Acting ß-Agonist (SABA) Use to Week 12	Participants recorded SABA use for 1 week prior to randomization (baseline) and the average number of days recorded was subtracted from average days of SABA use across 12 week intervention period.	Baseline to Week 12
Secondary	Change From Baseline in Daily Asthma Symptom Score to Week 12	Participants recorded their daily asthma symptoms in their electronic diaries (Ediary). It included 7 questions: frequency of night time awakening, time awake at night, wheezing, shortness of breath, cough, chest tightness and activity limitation.; Daily asthma symptoms score is the sum of 7 individual scores (with the total score ranging from 0-21).; Higher scores indicates worsening of condition and a negative change from baseline indicates improvement.	Baseline and Week 12
Secondary	Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12	The AQLQ is the most commonly used asthma specific instrument and includes evaluations of both symptom and quality of life measures. The 32-item instrument measures 4 domains affected by asthma including activity limitations, emotional function, exposure to environmental stimuli, and symptoms (Mitchell EA et al, 1997, Juniper et al, 1994, Christie MJ et al, 1993, Juniper et al, 1993).; Participants were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (7=no impairment, 1=severe impairment). The overall score = mean of the responses to the 32 questions.; Higher scores indicate "better quality of life" and a positive change from baseline indicates improved symptoms.	Baseline and Week 12
Secondary	Proportion of Asthma Symptom-free Days	Asthma symptom-free days were defined as a participant having a score of zero in their daily asthma symptom score. Asthma symptom-free days without SABA use were defined as a participant having a score of zero in their daily asthma symptom score and no SABA use.; The proportion of asthma symptom-free days was calculated as the number of asthma symptom-free days over the number of days in the double-blind treatment period (12 weeks).	Up to Week 12
Secondary	Time to Maximum Observed Concentration (Tmax) of AMG 827 at Week 8 to 10		Week 8 (days 60 and 64), and pre-dose on Week 10
Secondary	Maximum Observed Concentration (Cmax) of AMG 827 at Week 8 to 10		Week 8 (days 60 and 64), and pre-dose on Week 10
Secondary	Area Under the Concentration-time Curve During the Dosing Interval (AUCtau) of AMG 827 at Week 8 to 10		Week 8 (days 60 and 64), and pre-dose on Week 10

External Links

•   AmgenTrials clinical trials website