BI 443651 Methacholine Challenge

NCT03135899 | Completed Phase 1 Results

• 2 other identifiers: 1363.72016-001506-42
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to investigate safety and tolerability of three consecutive administrations, 12 hours apart, at three different dose-levels of BI 443651 administered via oral inhalation in male and female mild asthmatic subjects after a bolus methacholine challenge.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• Absolute Change From Baseline in Maximum Forced Expiratory Volume Within 1 Second (FEV1) Reduction Following Bolus Methacholine Challenge in Part 1

  Absolute change from baseline in maximum forced expiratory volume within 1 second (FEV1) reduction following bolus methacholine challenge in Part 1 was defined as the difference between the maximum reduction in FEV1 obtained during the treatment challenge and during the baseline challenge.

  Baseline and Day 2

• Absolute Change From Baseline in Maximum Forced Expiratory Volume Within 1 Second (FEV1) Reduction Following Bolus Methacholine Challenge in Part 2.

  Absolute change from baseline in maximum FEV1 reduction following bolus methacholine challenge in Part 2 was defined as the difference between the maximum reduction in FEV1 obtained during the treatment challenge and during the baseline challenge.

  Baseline and Day 2

Secondary Outcomes (4)

• Relative Change From Baseline in FEV1 Area Under the Curve Over the Time Interval From 0 to Timepoint tz (FEV1 AUC0-tz) Following Bolus Methacholine Challenge in Part 1

  Baseline and Day 2

• Relative Change From Baseline in FEV1 Area Under the Curve Over the Time Interval From 0 to Timepoint tz (FEV1 AUC0-tz) Following Bolus Methacholine Challenge in Part 2

  Baseline and Day 2

• Time to Recovery of FEV1 to Within 95% of Post-diluent Value in Part 1

  Day 2

• Time to Recovery of FEV1 to Within 95% of Post-diluent Value in Part 2

  Day 2

Study Arms (2)

BI 443651

EXPERIMENTAL

Drug: BI 443651

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 443651 DRUG

Three doses, each 12 hours apart

BI 443651

Placebo DRUG

Three doses, each 12 hours apart

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects must have a diagnosis of asthma by a physician at least 3 months prior to screening. The diagnosis of asthma must meet the following spirometric criteria:
• \-- Pre-bronchodilator clinic measured FEV1 \>=70% of predicted normal (calculated by the Global Lung Function Initiative equation (GLI)) measured \>= 8 hours after the last use of short acting bronchodilator at the screening visit and on the day of randomisation.
• Age \>= 18 \<= 60 years. Subjects must be within the eligible age range on the day of signing informed consent.
• ACQ value \< 1.5 at the screening visit.
• PD20 (Provocative dose causing at least a 20% decline in FEV1) at the screening visit of methacholine \<= 1mg
• Body mass index (BMI) \>= 18.5 and \<= 32.0 kg/m2 at the screening visit
• Subjects must be able to perform all study related procedures and assessments, including pulmonary function tests, as required by the protocol.

You may not qualify if:

• Significant pulmonary diseases other than asthma (up to GINA treatment step 2) or other medical conditions (as determined by medical history, examination and clinical investigations at screening) that may, in the opinion of the investigator result in any of the following:
• Put the subject at risk because of participation in the study
• Influence the results of the study
• Cause concern regarding the subject's ability to participate in the study.
• Respiratory tract infection or asthma exacerbation in the 4 weeks prior to the screening visit. Subjects can be rescreened 4 weeks after resolution of the infection or exacerbation.
• Hospitalisation for asthma exacerbation within 3 months or intubation for asthma within 3 years of the screening visit.
• Serum potassium measurement above the ULN at the screening visit. Any value about the ULN excludes the subject irrespective of clinical relevance.
• Blood donation (more than 100mL within 30 days prior to the administration of trial medication or intended during the trial)
• Subjects who have been treated with any of the following asthma medications in the given interval prior to Visit 1:
• Non-approved asthma therapies such as methotrexate,
• Intravenous, intramuscular or oral corticosteroids
• Inhaled corticosteroids (iCS) other than low dose iCS (defined as equivalent to equal to, or less than 250 μg fluticasone / day)
• A long acting beta agonist or anticholinergic bronchodilator (Visit 1), including fixed dose beta agonist/inhaled corticosteroid combinations and oral bronchodilators.
• A biological based antagonist therapy including Omalizumab, or immune modulators
• Asthma controller medications (e.g: leukotriene modifier, methylxanthines, nedocromil or cromolyn sodium)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

The Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 2, 2017
• Study Start: May 18, 2017
• Primary Completion: February 7, 2018
• Study Completion: February 21, 2018
• Last Updated: November 27, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-11

Locations

GB (1)