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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible 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
Positive methacholine challenge test reflecting mild to moderate bronchial hyperreactivity (PC20: 0.25-4.0 mg/mL) performed within two weeks prior randomization (at visit 1 or between visit 1 and 2)
None or stable dosages of pulmonary medications (SABA only) in the past 6 weeks
Non smokers or ex-smokers for the last 5 years
Signed and dated written informed consent prior to admission to the trial in accordance with GCP and the local legislation
Proper use of RMT and MDI
Able to perform technically satisfactory pulmonary function test
You may not be 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 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)
Any vulnerable subjects
Inability to comply with protocol requirements, instructions and study related restrictions, dietary regimen of trial site, and improbability of completing the study
Patients with mild asthma
Any finding of the medical examination (including BP, PR) deviating from normal and of clinical relevance
Any laboratory value that was of clinical relevance
Moderate or severe persistent asthma
Pregnant or breast feeding women or women of childbearing potential without a negative ß-HCG pregnancy test and without using a medically approved highly effective method of contraception for the previous 3 months
Clinically relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
Chronic or relevant acute infections
Treated or non-treated bacterial and viral infections of the lung, including active or latent tuberculosis
Use of any corticosteroids, long acting muscarinic antagonist (LAMA) or long acting beta agonists (LABA), all within 1 month prior to screening Visit 1 and prior to administration of investigational product (i.e., allergic patients could only participate outside their season)
Clinically relevant perennial allergies (i.e., which need actual treatment)
Methylxanthines, antihistamines, antileukotrienes, cromolyn/nedocromil sodium all within 1 month prior to screening Visit 1 and prior to administration of investigational product
SABAs 12 h prior to each visit day
Use of other drugs which reasonably influence the results of the trial within 10 days prior to first administration or during the trial (e.g., beta blockers, all antimuscarinic agents like phenothiazines and some antidepressants)
Participation in another trial with an investigational product 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 3 days prior to administration or during the trial)
Inability to comply with protocol requirements, instructions and trial related restrictions, dietary regimen of trial site, and improbability of completing the trial
Any vulnerable patients
Clareo Health | 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)
