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AsthmaPhase 2NCT01189396

Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006

A Phase 2 study testing A006 and Proventil-HFA in people with Asthma and Bronchospasm, run by Amphastar Pharmaceuticals, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic profiles of A006 (Albuterol Dry Powder Inhaler (DPI)), in comparison with those of an active control, Proventil-HFA (Albuterol Metered Dose Inhaler (MDI)), and a Placebo DPI in escalating and cumulative-doses up to 1440 mcg… Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
A006 and Proventil-HFA
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
27 participants
Where
4 sitesUnited States
Study dates
Jul 2010to Jan 2011
Phase
Phase 2
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 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Body weight ≥ 50 kg for men and ≥ 45 kg for women, and BMI within the range of 18.5 - 30.0 kg/m2 inclusive;
  • Sitting blood pressure ≤ 135/90 mmHg;
  • Demonstrating negative alcohol/drug screen tests;
  • Demonstrating negative HIV, HBsAg and HCV-Ab screen tests;
  • With mild-to-moderate persistent asthma for at least 6 months prior to Screening, and having used inhaled β-agonist(s) for asthma control;
  • Demonstrating a Mean Screening Baseline FEV1 at 50.0 - 85.0 % of predicted normal;
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  • Demonstrating a ≥ 15.0% Airway Reversibility in FEV1 within 30(±5) min after inhaling 2 actuations of Proventil-HFA;
  • Demonstrating Peak Inspiratory Flow Rate within 80-150 L/min;
  • Demonstrating proficiency in the use of DPI and MDI after training;
  • Females of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
  • Having properly consented to participate in the trial.

Who cannot join

  • Smoking history of ≥ 10 pack-years, or having smoked within 6 months prior to Screening;
  • Upper respiratory tract infections within 2 wk, or lower respiratory tract infection within 4 wk;
  • Asthma exacerbations that required emergency care or hospitalized treatment, within 4 wk prior;
  • Any current or recent respiratory conditions that might significantly affect pharmacodynamic response to the study drugs, besides asthma;
  • Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignancies, or other illnesses that could impact on the conduct, safety and evaluation of the study;
  • Known intolerance or hypersensitivity to any of the ingredients of the A006 or Proventil-HFA;
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  • Use of prohibited drugs or failure to observe the drug washout restrictions;
  • Having been on other clinical drug/device studies in the last 30 days;
  • Having donated blood within the last 30 days prior to Screening.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Amphastar Site 0025

    Medford, Oregon, 97504

  • Amphastar Site 0026

    Portland, Oregon, 97213

  • Amphastar Site 0032

    San Antonio, Texas, 78229

  • Amphastar Site 0034

    Seattle, Washington, 98105

Other trials in United States

About this study

Official title: A Randomized, Double- or Evaluator-blinded, Active- and Placebo-controlled, Cumulative-dose, Dose-escalating, Three-arm, Cross-over Study, in 24 Asthma Patients

The main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic profiles of A006 (Albuterol Dry Powder Inhaler (DPI)), in comparison with those of an active control, Proventil-HFA (Albuterol Metered Dose Inhaler (MDI)), and a Placebo DPI in escalating and cumulative-doses up to 1440 mcg, eight (8) times of the proposed clinical dose.

Being tested
A006, Placebo DPI, Proventil-HFA
Keywords
asthma, bronchospasm, COPD, reversibility, efficacy
Medical subject headings
Asthma, Bronchial Spasm, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A006Drug

    Albuterol DPI with 180 mcg Albuterol/inhalation

  • Placebo DPIDrug

    Placebo DPI with 0 mcg Albuterol/inhalation

  • Proventil-HFADrug

    Albuterol MDI with 90 mcg Albuterol/inhalation

Study groups in NCT01189396
Study groupRoleWhat they receive
TExperimentalFour doses of A006 taken in 30 minute intervals. Doses will have an escalating number of inhalations (1, 1, 2, and 4 inhalations). Total cumulative Albuterol dose at 90 minutes is 1440 mcg.
Receives: Drug: A006
RActive comparatorFour doses of Proventil-HFA taken in 30 minute intervals. Doses will have an escalating number of inhalations (2, 2, 4, and 8 inhalations). Total cumulative Albuterol dose at 90 minutes is 1440 mcg.
Receives: Drug: Proventil-HFA
PPlacebo comparatorFour doses of Placebo DPI taken in 30 minute intervals. Doses will have an escalating number of inhalations (1, 1, 2, and 4 inhalations). Total cumulative Albuterol dose at 90 minutes is 0 mcg.
Receives: Drug: Placebo DPI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bronchodilatory efficacy after the escalating and cumulative-doses, up to 1,440 mcg.

    Area Under the Curve (AUC)0-t of percent change in Forced Expiratory Volume in 1 second (FEV1), which is defined as the area under curve of post-dose FEV1 percentage changes from the Pre-dose Baseline FEV1 (FEV10) versus time. Doses are at 0, 30, 60 and 90 min.

    Measured: -15 min predose, 15 min post dose 1, 2 and 3 and 15, 45, 90, 120, 180, 240, 360 min post dose 4

Secondary outcomes (6)

  1. AUC0-t of change in FEV1

    AUC of FEV1 volume post-dose changes (change in Volume) from the Pre-dose Baseline FEV1 (FEV10). Doses are at 0, 30, 60 and 90 min.

    Measured: -15, 15 min post 1, 2, and 3, and 15, 90, 120, 240, and 360min post dose 4

  2. Time to onset

    Time to onset of bronchodilatory effect, determined by linear interpolation as the point where FEV1 % change first reaches ≥ 12% from FEV10.

    Measured: 0 - 120 min

  3. Peak Response

    The peak bronchodilator response, defined as the maximum post-dose FEV1 % change. Doses are at time 0, 30, 60, and 90 min.

    Measured: 15 min post dose 1, 2 and 3 and 15, 45, 90, 120, 180, 240, and 360 min post dose 4

  4. Adverse Events

    The adverse drug events (ADE) that are observed with Proventil-HFA may be expected with the use of A006

    Measured: Time 0, 15, 45, 75, 105, 150, 195, 130, 190, 250, 435 minutes post dose 1

  5. Blood Analysis

    serum glucose and potassium analysis and PK analysis

    Measured: -15, 10, 25,40, 55, 70, 85, 95, 115, 145, 175, 210, 270, 330, 690 min post dose 1

  6. Vital Signs and Electrocardiogram (ECG)

    vital signs, including pulse and blood pressure and 12-lead ECG

    Measured: -15, 5, 35, 65, 100, 155, 275, 455, 815 min post dose 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionDec 2010
  4. Study completionJan 2011

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01189396
Sponsor's protocol ID
API-A006-CL-C
Status last verified
Jun 2017
First submitted
24 Aug 2010
Last updated
2 Jul 2017
Results posted
No
Data monitoring committee
No

Publications

  • Ahrens RC. The role of the MDI and DPI in pediatric patients: "Children are not just miniature adults". Respir Care. 2005 Oct;50(10):1323-8; discussion 1328-30.

    PubMed 16185368

  • Goldstein DA, Tan YK, Soldin SJ. Pharmacokinetics and absolute bioavailability of salbutamol in healthy adult volunteers. Eur J Clin Pharmacol. 1987;32(6):631-4. doi: 10.1007/BF02456001.

    PubMed 3653233

  • Hindle M, Newton DA, Chrystyn H. Dry powder inhalers are bioequivalent to metered-dose inhalers. A study using a new urinary albuterol (salbutamol) assay technique. Chest. 1995 Mar;107(3):629-33. doi: 10.1378/chest.107.3.629.

    PubMed 7874928

  • Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. General considerations for lung function testing. Eur Respir J. 2005 Jul;26(1):153-61. doi: 10.1183/09031936.05.00034505. No abstract available.

    PubMed 15994402

  • Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68. doi: 10.1183/09031936.05.00035205. No abstract available.

    PubMed 16264058

  • Crapo RO, Morris AH, Gardner RM. Reference spirometric values using techniques and equipment that meet ATS recommendations. Am Rev Respir Dis. 1981 Jun;123(6):659-64. doi: 10.1164/arrd.1981.123.6.659.

    PubMed 7271065

  • Crapo RO, Morris AH, Clayton PD, Nixon CR. Lung volumes in healthy nonsmoking adults. Bull Eur Physiopathol Respir. 1982 May-Jun;18(3):419-25.

    PubMed 7074238

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing A006 and Proventil-HFA in people with Asthma and Bronchospasm, run by Amphastar Pharmaceuticals, Inc. at 4 sites in United States.

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 11 inclusion and 9 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Bronchodilatory efficacy after the escalating and cumulative-doses, up to 1,440 mcg. (time frame: -15 min predose, 15 min post dose 1, 2 and 3 and 15, 45, 90, 120, 180, 240, 360 min post dose 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01189396, which also lists 7 linked publications.

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 2 Jul 2017.

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