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A Pilot Study to Determine the Feasibility and Utility of Implementing of the Full Scale TOM Trial (SAPS)

2. januar 2019 oppdatert av: Joe Ramsdell, University of California, San Diego

SAPS:Smoking Asthmatics Pilot Study:

The primary aim of the pilot (SAPS) protocol is to determine the feasibility and utility of implementing the provisional design of the full scale TOM trial (e.g., the six month treatment period, the impact of the smoking cessation intervention).

There is no active hypothesis for the Vanguard Protocol.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The protocol is a small scale pilot of the full-scale TOM trial, and it will utilize a placebo design and incorporates 4 treatment arms. In the Vanguard Protocol all participants are to complete a 4 week run-in with Advair 100/50, followed by randomization to 1 of 4 arms of study treatment. The 4 drug treatment combinations are (2 inhalers, 2 pills):

  • Advair 250/50, Placebo, Placebo, Placebo
  • Advair 100/50 and montelukast, Placebo, Placebo
  • Advair 100/50 and theophylline, Placebo, Placebo
  • Advair 100/50 and ipratropium, Placebo, Placebo The 24 week treatment phase will be followed by a 4 week washout period on Advair 100/50. There is no crossover.

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • San Diego, California, Forente stater, 92103
        • Airway Research & Clinical Trials Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 50 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Gender and Age:
  • Males and females, ages 18- 50

Current Smoker:

  • Smoke at least 5 cigarettes per day for at least 5 years
  • Positive urine cotinine test

Asthma:

  • Physician diagnosed asthma

  • Symptomatic, as evidenced by

    • Use of SABA two or more times per week for relief of asthma symptoms, or
    • One or more nocturnal awakenings per week for asthma symptoms ACRC - SC MEETING - 19 MAY 2012 SAPS │ 25 Confidential, not for attribution or citation.
  • Pre-BD FEV1 greater than or equal to 40% predicted

  • Asthma diagnosis confirmed by either

    • albuterol reversibility of FEV1 by 12% or more, or
    • 20% fall in FEV1 at 8mg or less of methacholine
  • If over age 45, a DLco greater than 80% predicted
  • Females of childbearing potential: not pregnant, not lactating and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study.

Exclusion Criteria:

  • Diagnosis of COPD or emphysema

  • Other major chronic illnesses in the opinion of the investigator that might interfere with the study:

    - e.g. including but not limited to uncontrolled diabetes, uncontrolled HIV infection or other immune system disorder, hyperthyroidism, seizure disorders, renal failure, liver disease, non-skin cancer, unstable psychiatric illness.

  • Recent active substance abuse (in past 6 months)
  • Lung disease other than asthma including COPD, bronchiectasis, sarcoidosis, or other significant lung disease
  • Unstable cardiac disease (decompensated CHF, unstable angina, recent MI, atrial fibrillation, supraventricular or ventricular tachycardia, congenital heart disease, or severe uncontrolled hypertension).

  • High risk of near fatal or fatal asthma as defined by the following 1-3

    • ICU admission of asthma in the past year
    • more than 2 hospitalizations for asthma in the previous year
    • more than 3 ED visits for asthma in the previous year
    • intubation or ICU admission for asthma in the past 2 years
    • use of more than 2 canisters of inhaled short-acting beta2-agonist in past month
  • Acute asthma exacerbation in the past 4 weeks (treatment with systemic corticosteroids)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Faktoriell oppgave
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Ipratropium
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 2.5 mL, 0.02% 3 times daily via mini nebulizer with placebo theophylline and placebo montelukast.
Legemiddel: ipratropium
Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks.
Andre navn:
  • Atrovent
Placebo komparator: Theophylline
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and placebo montelukast.
Legemiddel: Theophylline 400 mg
Participants will be assigned to theophylline once a day for 24 weeks
Placebo komparator: Montelukast
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and placebo ipratropium.
Legemiddel: Montelukast 10mg
Participants will be assigned to montelukast once a day for 24 weeks.
Andre navn:
  • Singulair
Placebo komparator: fluticasone 250 mg/salmeterol 50mg
Participants will be assigned to inhaled fluticasone 250/salmeterol 50 twice a day for 24 weeks with placebo theophylline, placebo ipratropium, and placebo montelukast.
Legemiddel: Fluticasone 250 mg/salmeterol 50 mg
Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo
Andre navn:
  • Advair(fluticasone/salmeterol)250/50

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Asthma Control Test
Tidsramme: Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and at follow-up visit 1 month off study drug. Median scores over the 24 weeks of treatment were compared.
The primary symptomatic measure, the Asthma Control Test (ACT), has been shown to be valid for measuring poor asthma control in asthmatic children and non-smoking adults. The ACT is a tool developed by Nathan and collaborators a decade ago for evaluating asthma control. It consists of five questions with five possible answers each. A maximum score of 25 points indicates complete asthma control. A score between 20 and 24 represents partially controlled asthma, while a score 19 or below indicates poorly controlled asthma and a score <16 indicates uncontrolled asthma. The minimally important clinical difference has been determined to be 3.
Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and at follow-up visit 1 month off study drug. Median scores over the 24 weeks of treatment were compared.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Asthma Symptom Utility Index (ASUI)
Tidsramme: Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and a follow-up visit 1 month off study drug. Median scores, change from initial visit and end of treatment, were compared
The Asthma Symptom Utility Index (ASUI), an important secondary outcome in the proposed full-scale TOM Trial, has also been shown to be useful in tracking the frequency and severity of asthma-related symptoms in non-smoking asthmatics. ASUI is a brief, interviewer-administered, patient preference-based scale assessing frequency and severity of selected asthma-related symptoms and treatment side effects. 11 items are reviewed, with 2-week recall to assess four symptoms (cough, wheeze, shortness of breath, and awakening at night) and medication side-effects each on two dimensions (frequency and severity). 4-point Likert scale is used to assess frequency (not at all, 1 to 3 days, 4 to 7 days, and 8 to 14 days) and severity (not applicable, mild, moderate and severe). Scores range from 0 (worst possible symptoms) to 1 (no symptoms). The change between two time points, initial visit and after 24 weeks of treatment, is reported. The median value is reported with the standard deviation.
Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and a follow-up visit 1 month off study drug. Median scores, change from initial visit and end of treatment, were compared
Percent (%) Perdicted FEV1 Changes
Tidsramme: Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks. Median scores over the 24 weeks of treatment were compared
Physiologic measures of % predicted FEV1
Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks. Median scores over the 24 weeks of treatment were compared

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of California, San Diego

Samarbeidspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Etterforskere

  • Hovedetterforsker: Joe Ramsdell, MD, UCSD

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2012

Primær fullføring (Faktiske)

1. mai 2015

Studiet fullført (Faktiske)

1. november 2016

Datoer for studieregistrering

Først innsendt

25. juni 2012

Først innsendt som oppfylte QC-kriteriene

27. september 2012

Først lagt ut (Anslag)

28. september 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. januar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. januar 2019

Sist bekreftet

1. januar 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ARCTC-09
  • IR34HL109482-01A1 (Annet stipend/finansieringsnummer: National Heart, Lung, and Blood Institute (NHLBI))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

results will be presented been publication four-minute meetings

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