AsthmaPhase 1NCT02220673
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)
A Phase 1 study testing BHT 0.1% and BHT 0.5% in people with Asthma, run by Boehringer Ingelheim.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- BHT 0.1% and BHT 0.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to May 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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
Who cannot join
- 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
Show all 38Show fewer
- 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)
- 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 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
- 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
About this study
Official title: Serial Lung Function Measurements in 12 Healthy and 48 Mild Asthmatic Adults After Oral Inhalation of Ethanolic Solutions Containing Two Concentrations of the Excipient Butylated Hydroxytoluene (BHT, 0.1% and 0.5%) Administered With the Respimat® B (RMT-B) vs. Corresponding RMT-B and HFA MDI Without BHT; Repeated Increasing Doses With 2, 4, and 6 Actuations of Low Concentration Prior to High Concentration on Separate Days, Double Blind for RMT-B Use, Randomised 4-way Cross-over Design
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
- Being tested
- BHT 0.1%, BHT 0.5%, Placebo for RMT-B, Placebo for HFA-MDI
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHT 0.1%Drug
BHT 0.5%Drug
Placebo for RMT-BDrug
Placebo for HFA-MDIDrug
| Study group | Role | What they receive |
|---|---|---|
| BHT 0.1% | Experimental | Not described Receives: Drug: BHT 0.1% |
| BHT 0.5% | Experimental | Not described Receives: Drug: BHT 0.5% |
| Placebo for RMT-B | Placebo comparator | Not described Receives: Drug: Placebo for RMT-B |
| Placebo for HFA-MDI | Placebo comparator | Not described Receives: Drug: Placebo for HFA-MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline, 3 h after administration
Secondary outcomes (12)
Maximum decrease in FEV1 after 2 actuations
(minimum FEV1 value over the interval 5 min to 50 min) - (baseline value)
Measured: baseline, up to 50 minutes after drug administration
Maximum decrease in FEV1 after 4 actuations
(minimum FEV1 value over the interval 1 h 5 min to 1 h 50 min) - (baseline value)
Measured: baseline, up to 1:50 hours after drug administration
Maximum decrease in FEV1 after 6 actuations
(minimum FEV1 value over the interval 2 h 5 min to 2 h 50 min) - (baseline value)
Measured: baseline, up to 2:50 hours after drug administration
Number of subjects with a decrease in FEV1
stratified into classes of 0-20%, >20-40%, and >40%
Measured: baseline, up to 2:50 hours after drug administration
Number of patients with cough episodes
within 5 min prior to the 1st inhalation and within 5 min after each of the 3 inhalations on each treatment day
Measured: up to 9 days
Number of patients requiring rescue medication
Measured: up to 60 min after each dosing
Number of patients with adverse events
Measured: up to 10 days after the last treatment day
Cmax (maximum measured concentration of the analyte in plasma)
Measured: pre-dose, 2, 10, 25 and 55 min after each dosing
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Measured: pre-dose, 2, 10, 25 and 55 min after each dosing
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz)
Measured: pre-dose, 2, 10, 25 and 55 min after each dosing
Area under the curve (AUC) of FEV1
Measured: over 3 hours after first dosing
AUC of FEV1
Measured: over 1 hours after each dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startNov 2009
- Primary completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220673
- Sponsor's protocol ID
- 1256.13
- Status last verified
- Aug 2014
- First submitted
- 19 Aug 2014
- Last updated
- 20 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Lung Function Measurements in 12 Healthy and 48 Mild Asthmatic Adults After Oral Inhalation of Ethanolic Solutions Containing Two Concentrations of the Excipient Butylated Hydroxytoluene (BHT, 0.1% and 0.5%) Administered With the Respimat® B (RMT-B) vs. Corresponding RMT-B and HFA MDI Without BHT; Repeated Increasing Doses With 2, 4, and 6 Actuations of Low Concentration Prior to High Concentration on Separate Days, Double Blind for RMT-B Use, Randomised 4-way Cross-over Design
- ClinicalTrials.gov ID
- NCT02220673
- Acronym / sponsor ID
- 1256.13
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- May 2010 (actual)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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)
Key exclusion criteria (38 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Maximum decrease of forced expiratory volume in one second (FEV1)
Time frame: baseline, 3 h after administration
(Minimum FEV1 value over the interval 5 min to 2 h 50 min) minus (baseline value)
12 secondary outcomes
Maximum decrease in FEV1 after 2 actuations
Time frame: baseline, up to 50 minutes after drug administration
Maximum decrease in FEV1 after 4 actuations
Time frame: baseline, up to 1:50 hours after drug administration
Maximum decrease in FEV1 after 6 actuations
Time frame: baseline, up to 2:50 hours after drug administration
Number of subjects with a decrease in FEV1
Time frame: baseline, up to 2:50 hours after drug administration
Number of patients with cough episodes
Time frame: up to 9 days
Number of patients requiring rescue medication
Time frame: up to 60 min after each dosing
Number of patients with adverse events
Time frame: up to 10 days after the last treatment day
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: pre-dose, 2, 10, 25 and 55 min after each dosing
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Time frame: pre-dose, 2, 10, 25 and 55 min after each dosing
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz)
Time frame: pre-dose, 2, 10, 25 and 55 min after each dosing
Area under the curve (AUC) of FEV1
Time frame: over 3 hours after first dosing
AUC of FEV1
Time frame: over 1 hours after each dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BHT 0.1% and BHT 0.5% in people with Asthma, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum decrease of forced expiratory volume in one second (FEV1) (time frame: baseline, 3 h after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014.