Serial Lung Function Measurements in Healthy and Mild Asthmatic Adults After Oral Inhalation of Ethanolic Solutions Containing Two Concentrations of the Excipient Butylated Hydroxytoluene (BHT) Administered With the Respimat® B (RMT-B)

NCT02220673 | Completed Phase 1

• 1 other identifier: 1256.13
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary objective: To investigate the safety and local tolerability of increasing cumulative doses (2, 4, 6 actuations) of a low (0.1%) and a high (0.5%) concentration of BHT administered via oral inhalation with the Respimat® inhaler B (RMT-B) vs. 2 inhalation solutions without BHT (placebo to BHT given by RMT B and placebo given by hydroxylfluoralkane metered dose inhaler (HFA MDI)). In a first step, the trial was performed in healthy subjects and - if no safety concerns arose - in a second step in patients with mild asthma who were sensitive to metacholine in a respective challenge test. Secondary objective: To explore the pharmacokinetics (PK) of BHT.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Maximum decrease of forced expiratory volume in one second (FEV1)

  (Minimum FEV1 value over the interval 5 min to 2 h 50 min) minus (baseline value)

  baseline, 3 h after administration

Secondary Outcomes (12)

• Maximum decrease in FEV1 after 2 actuations

  baseline, up to 50 minutes after drug administration

• Maximum decrease in FEV1 after 4 actuations

  baseline, up to 1:50 hours after drug administration

• Maximum decrease in FEV1 after 6 actuations

  baseline, up to 2:50 hours after drug administration

• Number of subjects with a decrease in FEV1

  baseline, up to 2:50 hours after drug administration

• Number of patients with cough episodes

  up to 9 days

Study Arms (4)

BHT 0.1%

EXPERIMENTAL

Drug: BHT 0.1%

BHT 0.5%

EXPERIMENTAL

Drug: BHT 0.5%

Placebo for RMT-B

PLACEBO COMPARATOR

Drug: Placebo for RMT-B

Placebo for HFA-MDI

PLACEBO COMPARATOR

Drug: Placebo for HFA-MDI

Interventions

BHT 0.1% DRUG

BHT 0.1%

BHT 0.5% DRUG

BHT 0.5%

Placebo for RMT-B DRUG

Placebo for RMT-B

Placebo for HFA-MDI DRUG

Placebo for HFA-MDI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects
• Male or female adult subjects
• Age ≥ 18 and ≤ 65 years
• Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2
• Non-smokers (within the last 5 years)
• Signed and dated written informed consent prior to admission to the trial in accordance with Good Clinical Practice (GCP) and the local legislation
• Proper use of RMT and MDI
• Able to perform technically satisfactory pulmonary function test
• Patients with mild asthma
• Male or female adult subjects with intermittent and mild persistent asthma
• Age ≥ 18 and ≤ 65 years
• Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2
• FEV1 ≥ 70% predicted and stable for at least 7 days prior to randomization
• Short acting beta agonist (SABA) response documented in the last 6 months
• A history of wheeze, cough, dyspnoea or chest tightness following exposure to at least one of the following: cold, exercise, dry air, smoke, dust, allergens

You may not qualify if:

• Healthy subjects
• Any finding in the medical examination (including blood pressure (BP), pulse rate (PR)) deviating from normal and of clinical relevance
• Any laboratory value outside the reference range deemed of clinical relevance
• Pregnant or breast feeding women or women of childbearing potential without having a negative Human choriongonadotropin, β-subunit (ß-HCG) pregnancy test and without using a medically approved highly effective method of contraception for the previous 3 months
• Abnormal spirometry i.e., FEV1 \<80% predicted and/or methacholine challenge at screening Visit 1 (or between Visits 1 and 2)
• Acute or chronic bacterial and viral infections of the lung
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Clinically relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• Use of drugs which might reasonably influence the results of the trial within 10 days prior to first administration or during the trial (assessed and judged by the investigator)
• Participation in another trial with an investigational drug within 1 month prior to administration or during the trial
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Blood donation (\>120 mL within 4 weeks prior to administration or during the trial)
• Excessive physical activities (within 1 week prior to administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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

Study Design

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

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 20, 2014
• Study Start: November 1, 2009
• Primary Completion: May 1, 2010
• Last Updated: August 20, 2014

Record last verified: 2014-08